Dexcom CEO on ‘treading new ground’ with G6 glucose monitor

Kevin Sayer sold his first glucose sensor in 1994. More than twenty years later, the chief executive of Dexcom (NSDQ:DXCM) still believes that glucose-monitoring technology can transform the way patients manage their diabetes.

This week, Dexcom won FDA approval for its latest continuous glucose monitor. The G6 system is the first of the company’s that does not require a finger-prick for calibration and is also cleared as “fully interoperable” with other medical devices, like insulin pumps and decision support software.

“This Gen 6 system brings to fruition all that I envisioned when I first saw a sensor in the 90’s,” Sayer told Drug Delivery Business News. 

Get the full story at our sister site, Drug Delivery Business News.

The post Dexcom CEO on ‘treading new ground’ with G6 glucose monitor appeared first on MassDevice.

from MassDevice https://ift.tt/2GpTIUv

Congestive heart failure device dev Alleviant Medical raises $1m

Alleviant Medical has raised $1.1 million in a new round of debt and options financing, according to an SEC filing posted this week.

Money in the round came from 15 unnamed sources, according to the SEC filing, with the first sale recorded on December 19 last year.

The company is looking to raise an additional $434,000 in the round to bring the total raised to $1.5 million, according to an SEC filing. Alleviant Medical has not yet stated how it plans to spend funds raised in the round.

Alleviant Medical is developing a minimally invasive device designed to treat congestive heart failure.

The company’s device is designed to relieve pressure within the left atrium, according to its website, using an inter arterial shunt between the left and right atrium. The shunt is intended to allow pressure to offload from the left atrium into the lower pressure right atrium.

The post Congestive heart failure device dev Alleviant Medical raises $1m appeared first on MassDevice.

from MassDevice https://ift.tt/2uySpRv

Applied Medical touts surgical GI wound protector study data

Applied Medical this week released results from a meta-analysis study of wound protectors used during lower gastro intestinal procedures, touting their ability to reduce surgical site infections.

Results from the study were published this month in the journal Surgical Endoscopy, the Rancho Santa Margarita, Calif.-based company said.

Data from the analysis, which examined 12 randomized controlled trials with 3,029 participants, indicated that use of wound protectors like the company’s Alexis system significantly reduced rates of SSI patients undergoing lower GI surgery.

Furthermore, SSI rates were reduced by 63% when clinicians used dual-ring wound protectors, as compared to single wound-protectors, Applied Medical said. The company touted the analysis as the only such published study that focuses on wound protectors in lower GI surgery.

Applied Medical touted that its Alexis wound protector and retractor features a dual-ring design and 360-degree protection against surgical site infections.

“At Applied Medical, it’s our mission to enhance clinical care and improve patient outcomes. We work in partnership with our customers to help reduce surgical site infections through our products and programs. We’re proud to provide our dual-ring Alexis wound protector/retractor to hospitals worldwide to help meet clinical needs,” Applied Medical Horizon II division prez Serene Wachli said in a prepared statement.

The post Applied Medical touts surgical GI wound protector study data appeared first on MassDevice.

from MassDevice https://ift.tt/2GmZF4q

OmniGuide’s Domain Surgical launches ferromagnetic vessel-sealing shears

OmniGuide said yesterday its subsidiary Domain Surgical launched its FMsealer laparoscopic shears designed for surgical vessel sealing.

The Lexington, Mass.-based company touted the newly released FMsealer as the only vessel sealing instrument based on ferromagnetic surgical energy, which it claims provides quick transection with minimal thermal impact on surrounding tissue.

The device is cleared for sealing vessles up to 7mm in diameter, including lymphatics in open and laparoscopic procedures, OmniGuide said.

“The FMsealer Laparoscopic Shears offers intuitive plug-and-play capabilities with our award-winning FMX Ferromagnetic Surgical System; expanding the utility of our electrically silent precision-based surgical platform. The FMsealer provides surgeons with an optimal combination of reliability, efficiency, customization, and safety in a variety of laparoscopic procedures, without passing potentially dangerous electrical current through the patient,” OmniGuide CEO John Buhler said in a prepared statement.

OmniGuide said that the FMsealer had been shown to be safe and effective in a peer-reviewed article of the device published last year in the journal Surgical Laparoscopy, Endoscopy & Percutaneous Techniques.

OmniGuide acquired Domain Surgical and its FMX ferromagnetic surgical system in August 2016 for an undisclosed amount.

The post OmniGuide’s Domain Surgical launches ferromagnetic vessel-sealing shears appeared first on MassDevice.

from MassDevice https://ift.tt/2IjgnCl

Bovie Medical launches Renuvion cosmetic surgery J-Plasma brand

Bovie Medical (NYSE:BVX) said yesterday it launched the Renuvion brand of cosmetic surgery devices using its J-Plasma technology.

Through the newly launched brand, the Clearwater, Fla.-based company said it will sell devices powered by the J-Plasma technology specifically for the cosmetic surgery market.

The J-Plasma device is a plasma-based cutter and coagulator that uses helium ionization to produce a focused beam of ionized gas over a blade, used for cutting or coagulating during surgeries, Bovie Medical said.

“On behalf of Bovie Medical, I am excited to announce the launch of the Renuvion brand, which we have developed as part of our commitment to enhancing our ability to commercialize our J-Plasma technology in the cosmetic surgery market. The Renuvion brand – and its taglines: Reshaping What’s Possible and What will you renu? – represent the potential that we see for our transformational J-Plasma technology to positively impact physician practices and the lives of their patients. Most importantly, Renuvion was created specifically for physicians in the cosmetic surgery market, including plastic surgeons, cosmetic surgeons and dermatologists, who will be able to leverage the increasing awareness of this brand as we establish Bovie Medical as a provider of innovative technologies in this market,” CEO Charlie Goodwin said in a prepared statement.

In January, Bovie Medical said it launched an FDA investigational device exemption clinical study of its J-Plasma surgical cutter, looking to explore the use of the device in dermal skin resurfacing.

The post Bovie Medical launches Renuvion cosmetic surgery J-Plasma brand appeared first on MassDevice.

from MassDevice https://ift.tt/2GKpzml

Why partnerships between medtech companies and doctors are so important

Laura Dietch, CEO of BioTrace Medical [Image from BioTrace Medical]

As new devices and technologies are being developed in the medtech industry, doctors and physicians have to learn about the devices on platforms that are different from what they know. One way to help make the healthcare provider’s transition into using new devices easier is to forge a partnership between the industry and the physician, according to Laura Dietch, CEO of BioTrace Medical (Menlo Park, Calif.).

BioTrace Medical is a medical device company that makes temporary pacing leads to improve patient outcomes while also reducing hospital costs. The company’s Tempo Lead uses an active fixation mechanism, bipolar electrodes and a soft tip to create secure and stable cardiac pacing and reduce complications following cardiovascular procedures.

“We are pleased that the growing adoption of the Tempo Lead is resulting in an increasing body of evidence that continues to validate the Lead’s safety and effectiveness, both intra- and post-procedure, as well as its contribution to reducing costs,” said Dietch. “The Tempo Lead is already migrating throughout the hospital wherever safe, stable, temporary pacing is needed.”

Get the full story on our sister site, Medical Design & Outsourcing.

The post Why partnerships between medtech companies and doctors are so important appeared first on MassDevice.

from MassDevice https://ift.tt/2Gl52Fo

Allina Health and Zipnosis partner to expand online care platform

Allina Health and Zipnosis have recently partnered to update Allina Health’s online diagnosis and treatment service.

Allina Health recently launched its Everyday Online platform that is powered by virtual care company Zipnosis. Allina Health Everyday Online is designed to bring convenient access to patients through Minnesota and Western Wisconsin.

Get the full story on our sister site, Medical Design & Outsourcing.

The post Allina Health and Zipnosis partner to expand online care platform appeared first on MassDevice.

from MassDevice https://ift.tt/2uwTCJh

Medicrea inks Belgian JV deal with Motion Medical

Medicrea (EPA:ALMED) said today it inked a joint-venture deal with Belgian distributor Motion Medical looking to accelerate adoption of its products in Belgium.

France-based Medicrea will hold a 51% majority stake in the newly formed Medicrea Belgium with plans to transition the JV into a fully-owned Medicrea subsidiary over the coming years.

The newly founded subsidiary will be led by Motion Medical head Steven Mesdom, who will also remain in on board at Motion Medical, Medicrea said.

“We have had an exceptional track record introducing Medicrea’s flagship platforms to Belgium, including PASS thoracolumbar fixation. This partnership marks an important step for our continued penetration of the Belgian market,” Mesdom said in a prepared statement.

“We are extremely pleased to have successfully negotiated this mutually-beneficial agreement with Mr. Mesdom and to announce the creation of Medicrea Belgium, a direct sales subsidiary. Our collective experience in this market will allow us to capitalize on a direct sales model and immediately generate additional revenue for the group. In addition, we will create new opportunities for growth with the latest patient-specific UNiD ASI technologies,” Medicrea prez & CEO Denys Sournac said in a press release.

Last November, Medicrea said it won FDA clearance for its IB3D portfolio of 3D-printed titanium interbody devices featuring its AdapTEK technology.

The post Medicrea inks Belgian JV deal with Motion Medical appeared first on MassDevice.

from MassDevice https://ift.tt/2H1Ke2U

NuVasive touts Porous PEEK interbody implant study

NuVasive (NSDQ:NUVA) yesterday released results from a study of the company’s Porous PEEK material compared against titanium-coated PEEK and smooth PEEK material used in interbody fusion devices, touting advantages of its proprietary materials.

Results from the study were published in The Spine Journal.

In the study, researchers compared interbody implants composed of titanium-coated PEEK, smooth PEEK and NuVasive’s Porous PEEK, which were all subjected to impaction loading conditions.

Results indicated that the Porous PEEK implants maintained a greater than 65% porosity with minimal changes to pore size and depth following impaction. Titanium-coated PEEK implants showed titanium coating loss after impaction with a decrease in surface roughness, while smooth PEEK showed minimal signs of damage and a decrease in surface roughness, the company said.

“The findings in this study are significant because they demonstrate the durability and impaction resistance of interbody implants made from Porous PEEK. Knowing that the porous structure is seamlessly integrated with the implant, without sacrificing implant strength, and that the implant maintains porosity following impaction means that the opportunity for bony ingrowth is optimized,” Dr. Kevin Foley said in a prepared statement.

“Porous PEEK exemplifies our focus on disruptive technology and materials science. Born out of years of pre-clinical research, this durable implant technology combines the inherent benefits of porosity with the advantageous material properties of PEEK. Designed for enhanced osseointegration, biomechanical, and imaging properties, Porous PEEK and the entire NuVasive advanced materials science portfolio, which also includes Modulus titanium interbody implants, represent the future of porous implant technologies,” NuVasive strategy, tech and corp dev EVP Matt Link said in a press release.

Earlier this month, NuVasive said it is appealing a $27.8 million loss to distributor Madsen Medical in a sales poaching case, with the new case slated for April 18.

The post NuVasive touts Porous PEEK interbody implant study appeared first on MassDevice.

from MassDevice https://ift.tt/2pRm2c5

FDA reschedules eMDR system update

The FDA recently announced that the eMDR adverse event code update that was originally set to take place on April 6 has been rescheduled for July 5.

The delay in update will give AS2 submitters more time to develop and validate changes to adverse event compliant handling system with the test eMDR system that was updated on March 6.

Get the full story on our sister site, Medical Design & Outsourcing.

The post FDA reschedules eMDR system update appeared first on MassDevice.

from MassDevice https://ift.tt/2Gpf97W

T2 Biosystems touts results from 4 studies of its T2Dx diagnostics system

T2 Biosystems this week released results from four studies of its T2Dx blood diagnostics system designed to detect pathogens that cause sepsis, touting clinical and performance advantages when compared to traditional blood cultures.

The four studies were published in the Journal of Antimicrobial Chemotherapy, the Lexington, Mass.-based company said.

A study conducted at Rome’s Gemelli Hospital examined the use of the T2Bacteria panel on the T2Dx, and found that positive results were produced 4.5 times faster at 5.5 hours versus 25 hours with a standard blood culture. Negative results on the T2Bacteria panel were produced 20 times faster at 6.1 hours versus 120 hour for blood cultures.

The T2Bacteria panel had a reported 89.5% sensitivity and 98.4% specificity in comparison with clinical criterion of a true infection. Study authors also said that 66.7% of clinically infected patients missed by blood culture were identified by the T2 Bacteria panel.

“Our study demonstrates that the T2Bacteria Panel has the speed and accuracy to detect deadly, sepsis-causing infections, leading to more targeted therapy for patients and improved stewardship for the hospital. T2Bacteria is a very important advance in the fight against sepsis, and we are excited to be among the first hospitals to demonstrate its value,” Dr. Maurizio Sanguinetti of Gemelli Hospital said in a prepared statement.

A second study, performed at Florida’s Lee Health, found that patients suspected of Candida infections received therapy 6 times faster, at 6 hours versus 34 hours with conventional testing. Average duration of antifungal therapy after T2Dx testing was also reduced by 4 days, with therapy discontinued after a single dose or avoided entirely by 58.4% of patients without an increase in patient mortality.

Two studies from Madrid’s Gregorio Marañón Hospital reported that positive T2Candida panel results identified patients with an over 30 times increased risk of developing health complications, and was a better predictor of patient risk than existing diagnostic tests.

The use of the T2Candida panel was also shown to reduce the duration of antifungal therapy for 67% of patients, and was able to distinguish between complicated and uncomplicated infections better than existing tests.

“The predictive value of the T2Candida Panel represents an important advance in our understanding of the clinical uses of T2Dx diagnostics. A T2Candida Panel positive demonstrated a 30x increase in the likelihood of a complicated infection and showed significant advantages over beta-D-glucan, blood culture and CAGTA. Together, these studies demonstrate that the T2Dx Instrument is a powerful stewardship tool that can help inform clinicians when they can safely reduce the use of antimicrobial drugs – or when a patient needs more aggressive treatment,” Dr. Patricia Muñoz of Madrid’s Hospital General Universitario Gregorio Marañón said in a press release.

Earlier this month, T2 Biosystems won a $2 million grant to develop a test using its T2Dx MR-based technology to detect strains of drug-resistant bacteria or so-called “superbugs.”

The post T2 Biosystems touts results from 4 studies of its T2Dx diagnostics system appeared first on MassDevice.

from MassDevice https://ift.tt/2IdMJyw

Apple launches Health Records, gives patients smartphone-based EHR access

Apple (NSDQ:AAPL) is continuing its journey into the healthcare industry, saying yesterday it moved the Health Records functionality in its iOS-based Health app out of the beta phase, allowing all patients of 39 US health systems direct access to their electronic health records.

With the update, individuals belonging to the chosen health systems will be able to actively view electronic health records from various organizations in a single view, and will be able to receive notifications when that data is updated.

The health records stored on the phone are encrypted by the user’s iPhone or iOS device passcode, Apple said. The company added that it is hopeful that the new functionality will help patients have more informed conversations with their physicians and family members, and enable better-informed future decisions.

Participants in the program include NYU Langone Health, Johns Hopkins Medicine, Cerner Health Clinic, CoxHealth, Adventist Health System, BayCare Health System, Cedars-Sinai, Scripps Health and Stanford Medicine, amongst 30 other systems across the US.

“Any time you can put information in patients’ and doctors’ hands and allow there to be more informed decision making, that is the best of all,” Stanford department of medicine chair Dr. Robert Harrington said in a press release.

Last month, Apple reportedly began collecting data it could use in pursuit of FDA approval for an iOS-based health and heart monitoring program.

The post Apple launches Health Records, gives patients smartphone-based EHR access appeared first on MassDevice.

from MassDevice https://ift.tt/2J503GE

Sunovion seeks FDA nod for sublingual film to treat Parkinson’s disease

Sunovion Pharmaceuticals submitted a new drug application to the FDA this week for its apomorphine sublingual film designed to treat motor fluctuations experienced by people with Parkinson’s disease.

The Marlborough, Mass.-based company is testing the film as a therapy for Parkinson’s patients experiencing “off” episodes – when symptoms that are otherwise controlled by medications resurface. As many as 60% of Parkinson’s patients have these kinds of episodes, according to the company.

Get the full story at our sister site, Drug Delivery Business News.

The post Sunovion seeks FDA nod for sublingual film to treat Parkinson’s disease appeared first on MassDevice.

from MassDevice https://ift.tt/2pS1Rdb

Foundation Medicine launches genomic profiling test for solid tumors

Foundation Medicine (NSDQ:FMI) today launched the first FDA-approved comprehensive genomic profiling assay for all solid tumors in the U.S.

The test, FoundationOne CDx, is designed to detect specific genomic alterations and help doctors make personalized treatment decisions for their patients.

Get the full story at our sister site, Drug Delivery Business News.

The post Foundation Medicine launches genomic profiling test for solid tumors appeared first on MassDevice.

from MassDevice https://ift.tt/2E7fWIR

FDA committee backs Senseonics’ implantable continuous glucose monitor

An FDA advisory panel voted unanimously to recommend approval for Senseonics‘ (NYSE:SENS) implantable continuous glucose monitor, Eversense, the company touted this week.

The panel of medical experts voted 8-0 that the benefits of the technology outweigh the risks and that the system, which works for up to 90 days, is safe and effective.

Get the full story at our sister site, Drug Delivery Business News.

The post FDA committee backs Senseonics’ implantable continuous glucose monitor appeared first on MassDevice.

from MassDevice https://ift.tt/2pQWThI

7 digital health startups you need to watch in 2018

If you want to see where the big money is going in healthcare these days, digital health products are the place to look. Digital health startups raised $11.5 billion in 2017, up 27 percent over 2016, according to the StartUp Health Insights Year End Report.

Digital health startups are doing everything from enhancing patient-provider relationships to streamlining workflows within health systems, and they’re raising a lot of money along the way.

The influx of cash for a digital health startup ranges from $1 million up to $100 million. Even more exciting, early-stage deals made up 65 percent of the total deal activity. Series A funding was 36 percent of the total funding, and seed funding made up 29 percent of the total funding. Series D funding increased from 2 percent in 2016 to 4 percent in 2017.

Digital health products are compelling in a few ways, particularly to investors. They meet a similar schedule of investment to other digital technology products aimed at consumers, and they won’t require the level of regulatory rigor demanded by traditional and even connected medical devices.

They also serve a real need in healthcare. Many of the startups on this list aim to help patients get connected to physicians or to patient communities, and give them access to a complete body of care. Others work to generate population health data or prioritize physician workflow and integration with payers to improve the standards of care.

The editors of MassDevice and Medical Design & Outsourcing can’t ignore such a huge focus of funding, We also wanted to share the digital startups we think are interesting before they get bought by Apple, Google or Amazon. All the companies selected for this list are less than 5 years old and either in seed or series A funding rounds. However, many are already doing pilot studies to expand services and entering into agreements with big providers and payers.

Next>>

The post 7 digital health startups you need to watch in 2018 appeared first on MassDevice.

from MassDevice http://bit.ly/2GCpIYO

Digital woundcare dev Swift Medical raises $12m

Canadian digital health dev Swift Medical said today it raised $11.6 million in Series A funding to help support its digital wound care management system designed to assess and monitor wounds.

The round was led by Data Collective and joined by Real Ventures Relay Ventures and the Business Development Bank of Canada in Montreal, the Toronto-based company said.

Swift Medical has developed a smartphone-ready system, called Swift Skin and Wound, that captures images and measurements of wounds including wound depth without having to touch the wound or use other tools, including rulers or acetate tracings. The system also allows patients and attending clinicians to track their wounds during healing, the company said.

“This growth funding enables us to expand our reach and bring Swift’s solution to every bedside in every hospital and care facility. There are more patients worldwide suffering from chronic wounds than from lung cancer, breast cancer, colon cancer and leukemia combined. By augmenting the abilities of clinicians and facility administrators to deliver the best possible wound care management, we’re helping them heal over 10,000 patients a month. And we’re just getting started,” co-founder & CEO Carlo Perez said in a prepared statement.

“Swift’s product execution is a wonderful example of Data Collective’s computational care philosophy of pushing compute intelligence closer to the patient, but in a way that is empathetic to the patient and the caregivers and systems that surround them. We invested because of Swift’s near science-fiction quality machine vision, Carlo’s leadership, and because Swift enables wound care quality that all of us should demand for a loved one,” Data Collective partner Scott Barclay said in a press release.

The post Digital woundcare dev Swift Medical raises $12m appeared first on MassDevice.

from MassDevice http://bit.ly/2E6hBOS

Titan Medical, Mimic Tech collab on Sport surgical simulation modules

Titan Medical (TSX:TMD) said today it inked a collaborative deal with robotic simulation developer Mimic Technologies to develop simulation modules for Titan’s Sport robotic surgical platform.

Toronto-based Titan Medical said that surgical simulations using its Sport surgical system have been successfully demonstrated, which it claims is the first step towards developing a “comprehensive surgeon training curriculum” for the system.

“Mimic is delighted to partner with Titan to build revolutionary simulation systems that prepare surgeons for safe and efficient robotic surgery. Both Mimic and Titan believe that training is the cornerstone of a successful robotic surgery program. We applaud Titan’s forward-looking approach to simulation training by its commitment to launch the Sport Surgical System with a full suite of simulation software in place. By emphasizing simulation as part of a comprehensive training program, we hope to expedite the learning curve for surgeons looking to offer Sport single port robotic surgery to their patients,” Mimic Tech founder & CEO Jeff Berkley said in a prepared statement.

“We are thrilled to announce this strategic collaboration with Mimic Technologies, and with the successful demonstration of Mimic’s first simulation modules on our surgeon workstation, deliver an important product development milestone right on schedule. Mimic, with its experience and leadership in simulation training for robotic surgery, provides us with a proven component of surgeon training in preparation for clinical adoption of our Sport Surgical System. Simulation training has evolved with robotic surgery and it will continue to play a vital role in the successful implementation of new robotic programs. Surgeons and hospital administrators alike have indicated that simulation will remain a preferred training regimen in the future. We are leveraging Mimic’s deep subject matter expertise and well-accepted simulation exercises in order to provide best-in-class simulation training at product launch. By doing so, we believe we can accelerate the learning curve, reduce training and operating costs, and mitigate potential risks associated with the implementation of our robotic technology. We enthusiastically look forward to completing the full simulation training curriculum for our Sport Surgical System with the Mimic team of simulation experts,” Titan Medical prez & CEO David McNally said in a press release.

Last month, Titan Medical released its full year 2017 financial results, touting that it met all its milestones during the year and that its Sport system was used in the first single-port procedures.

The post Titan Medical, Mimic Tech collab on Sport surgical simulation modules appeared first on MassDevice.

from MassDevice http://bit.ly/2Gki6ef

Avinger touts 1st use of extended-nosecone Pantheris cath

Avinger (NSDQ:AVGR) said today it launched its Pantheris lumivascular atherectomy system with extended nosecone in the European Union, touting that the device has been used in its first human patients.

The device was used by Dr. Arne Schwindt in treating peripheral artery disease in three patients at Münster, Germany’s St. Franziskus Hospital, the Redwood City, Calif.-based company said.

“Despite the difficult nature of these particular interventions, I was able to safely and effectively achieve positive outcomes for these patients using the new version of Pantheris with the extended nosecone. I am excited to continue to use this technology in lesions with higher plaque burden, and continue to see the added benefit of the design improvements incorporated into the next generation Pantheris platform,” Dr. Schwindt said in a prepared statement.

The new version of the device features a longer nosecone for improved plaque removal, Avinger said, and is qualified for sale in European Union under its existing CE Mark. The company said the extended nosecone increases storage capacity of the Pantheris system by 75%, which it says will result in improved procedural efficiency.

“We appreciate Dr. Schwindt’s continued partnership with us in our objective to improve physician user experience with our technology while continuing to generate positive patient outcomes. Dr. Schwindt’s feedback will continue to be invaluable as we launch our Pantheris next generation platform in additional sites both in the EU and in the US, once we receive FDA 510(k) clearance,” prez & CEO Jeff Soinski said in a press release.

Earlier this month, Avinger said it inked a $5 million deal to settle a class-action investors suit against the company and several of its officers and directors.

The post Avinger touts 1st use of extended-nosecone Pantheris cath appeared first on MassDevice.

from MassDevice https://ift.tt/2GVqfmp

NeoVasc shares tumble on 2017 earnings release, sales slide nearly 50%

Shares in Neovasc (NSDQ:NVCN) have fallen nearly 50% today after the structural heart device maker posted shrinking sales in its 2017 earnings release and updated on progress with its investigational Tiara mitral valve replacement.

The Vancouver-based company posted losses of $22.9 million, or 28¢ per share, on sales of $5.4 million for the full 2017 year, seeing losses shrink 73.5% while sales shrunk 43.3% compared with the previous fiscal year.

Losses per share were just behind the 26¢ consensus on Wall Street, where analysts were expecting to see sales of $4.1 million, which the company handily topped.

NeoVasc said that a total of 50 patients have been treated with its investigational Tiara mitral valve system to date. A total of 12 of those patients come from its 150-patient European Tiara II CE Mark study, with 2 additional patients scheduled for implantation and others “currently under evaluation for eligibility.”

The company said that it has developed a new tool to hasten enrollment in the study, and that it expects the CE Mark trial to be complete by approximately 2020.

NeoVasc said a total of 21 patients were implanted with the Tiara valve in 2017, with a 100% technical success rate and a 90% survival rate at 30 days.

“Since joining Neovasc in late January, I have been evaluating the company’s current clinical and commercial activities, as well as organizational and financial matters. We are making adjustments to these programs and have started to implement a broader turnaround strategy designed to more effectively create value for our patients, customers, shareholders and employees, while bringing our innovative products to market. We still face challenges, however, I believe that our innovative and promising products, as well as the determination of our team, will lead us to long-term success. We have three specific tasks to focus on, in order to recognize the potential of our Tiara and Reducer products. Our goal is to expand on the foundation we established in Europe and on the growing enthusiasm in the market for the Reducer therapy, based on the initial, promising clinical experiences. We also remain pleased with the clinical results to-date from the first 50 Tiara implants, with ongoing enrollment in our Tiara I and II studies, as well as the initiation of the development of the transfemoral, trans-septal version of Tiara,” CEO Fred Colen said in a press release.

Shares in Neovasc are down 50% so far today, at 6¢ as of 1:05 p.m. EDT.

In February, NeoVasc said that it won reimbursement coverage from the German Institute for the Hospital Renumberation System for its Reducer device designed to treat refractory angina.

The post NeoVasc shares tumble on 2017 earnings release, sales slide nearly 50% appeared first on MassDevice.

from MassDevice https://ift.tt/2GkKPvh

Inari Medical raises $27m

Inari Medical said today it closed a $27 million Series C round of financing, with funds slated to support commercialization of its FlowTriever and ClotTriever catheters designed for the treatment of venous thromboembolisms.

Irvine, Calif.-based Inari’s ClotTriever device is designed to remove blood clots from large vessels in the peripheral vasculature, while it’s FlowTriever device is designed to retrieve pulmonary embolisms.

The round was led by newly invested Gilde Healthcare and joined by all of Inari’s existing investors, including Versant Ventures and U.S. Venture Partners. Inari said that as part of the round, Gilde Healthcare’s Geoff Pardo will join the company’s board of directors.

“We are fortunate to have the support of a strong consortium of life sciences venture capital firms and would like to welcome both Gilde Healthcare as an investor in Inari and Geoff Pardo as a board member. We will use these funds to support and accelerate our commercial, clinical and technology development programs,” prez & CEO Bill Hoffman said in a prepared statement.

“There is a significant need to improve outcomes for the millions of patients suffering from VTE. We have been impressed by the Inari team, the progress they’ve made to date and their vision to transform the treatment of VTE,” Gilde Healthcare’s Pardo said in a press release.

Last April, Inari Medical touted that it its ClotRetriever thrombectomy device, approved by the FDA on February 16, had already been used in its first commercial procedure.

The post Inari Medical raises $27m appeared first on MassDevice.

from MassDevice https://ift.tt/2J2wiWO

Zimmer Biomet touts 7-year results in Mobi-C cervical disc trial

Zimmer Biomet (NYSE:ZBH) yesterday released seven-year follow-up results from a study of its Mobi-C cervical disc device designed for total disc replacement procedures, touting lower pain, maintained motion range and other benefits.

Results from the study were published in the International Journal of Spine Surgery, the Warsaw, Ind.-based company said.

In the study, researchers compared the use of the the Mobi-C cervical total disc replacement system against the previous standard of care, anterior cervical discectomy and fusion, in nearly 600 patients over seven years.

Results indicated that use of the Mobi-C during cTDR procedures was associated with lower pain scores, a maintained range of motion, less adjacent level degeneration and subsequent adjacent level surgeries and a lower rate of secondary surgery when compared to ACDF.

Follow-up rates in the trial ranged from 73.5% to 84.4%, with overall success rates for patients undergoing two-level cTDR of 60.8% versus 34.6% for ACDF. Success rates were more similar between one-level patients, with 55.2% for cTDR patients and 50% for ACDF.

Researchers indicated that the composite success analysis showed the two-level cTDR was superior over ACDF, and that one-level cTDR was non-inferior versus ACDF.

Results also indicated a higher Neck Disability Index success rate in two-level cTDR over ACDF at 79% versus 58%, respectively. More than 86% of patients who received two-level cTDR and 73.9% of patients who underwent ACDF were “very satisfied” with the outcomes at seven years.

“This study further validates the strengths of Mobi-C as a solution for cervical total disc replacement. The positive clinical outcomes remain consistent with previous findings, mainly that Mobi-C continues to deliver positive patient outcomes including efficacy, safety, patient satisfaction and fewer follow-up surgeries. It is particularly important that the clinical effectiveness of cTDR versus ACDF becomes more apparent when treatment increases from one to two levels, indicating a significant benefit for Mobi-C in two-level procedures, which affects an estimated one in three cervical disc patients,” Zimmer Biomet spine division GM Joe Ross said in a press release.

Earlier this week, Zimmer Biomet said it will participate in the US Dept. of Energy’s Better Buildings, Better Plants energy reduction programs as it looks to reduce its carbon footprint in the US and Puerto Rico.

The post Zimmer Biomet touts 7-year results in Mobi-C cervical disc trial appeared first on MassDevice.

from MassDevice https://ift.tt/2J6PqTO

Abbott launches new CardioMems trial

Abbott (NYSE:ABT) said today it launched a new trial of its CardioMems HF implantable cardiac monitoring system, exploring the device’s ability to improve survival and quality of life for people with New York Heart Association Class II to Class IV heart failure.

The study, dubbed the Guide-HF trial, is slated to enroll a total of 3,600 patients at 140 hospitals across North America as the company looks to expand coverage for the device.

“Monitoring pulmonary artery pressure with Abbott’s CardioMems device has already been shown to offer improvements in patient care. We now want to build a stronger body of clinical evidence, with Guide-HF, that establishes its role in improving patient survival,” primary investigator Dr. JoAnn Lindenfeld of Nashville’s Vanderbilt University Medical Center said in a prepared statement.

The trial will examine patients with stage C, NYHA Class II-IV heart failure with either elevated brain-type natriuretic peptide levels or prior heart failure hospitalizations in the past 12 months, Abbott said.

The first patients have already been enrolled in the trial, Abbott said, with the first implants taking place at the Southfield, Mich.-based Providence Hospital by Dr. Marcel Zughaib and Dr. Herman Kado, at the Sioux Falls, S.D.-based Sanford Medical Center by Dr. Orvar Jonsson and at Austin’s Austin Heart by Dr. Kunjan Bhatt.

“Data suggests that proactively managing people living with heart failure may change the course of the disease’s progression. The CardioMEMS HF System is the first-of-its-kind approach to redefine heart failure management. The Guide-HF study sets out to make this technology available to an expanded group of people who could benefit from it,” Abbott heart failure biz medical director & divisional VP Dr. Philip Adamson said in a press release.

Earlier this month, Abbott said that it logged a reimbursement win in Japan for its MitraClip device for treating mitral valve regurgitation.

The post Abbott launches new CardioMems trial appeared first on MassDevice.

from MassDevice https://ift.tt/2uuwuet

Is 3D printing going to replace injection molding?

3D-printed Tyrannosaurus rex models, made with Carbon’s proprietary CLIP technology. [Image courtesy of Carbon]

3D printing and injection molding each have their own benefits and limitations when it comes to making medical device parts, according to experts from PTI Engineered Plastics, Carbon and Protolabs. 

Medical device parts makers are increasingly turning to 3D printing, but additive manufacturing has yet to reach the tipping point where it could supplant injection molding in medtech parts manufacturing, according to a March 8 experts panel at the AD&M Cleveland show in March.

Whether a manufacturer uses 3D printing or injection molding is completely reliant on what a customer’s needs are, said the experts from PTI Engineered Plastics, Carbon and Protolabs.

In fact, the two processes may be more of a dynamic duo.

One of the advantages of 3D printing is that a manufacturer can get their hands on a product quicker than they would be able to with injection molding, while having the ability to completely customize the product. In contrast, injection molding allows parts to be produced in mass volumes.

Get the full story on our sister site, Medical Design & Outsourcing.

The post Is 3D printing going to replace injection molding? appeared first on MassDevice.

from MassDevice https://ift.tt/2E5cfmN

AngioDynamics shares down on fiscal Q3 sales miss

Shares in AngioDynamics (NSDQ:ANGO) have fallen today after the medical device maker posted fiscal third quarter earnings that beat earnings per share expectations but fell short on sales.

The Latham, N.Y.-based company posted profits of $14 million, or 37¢ per share, on sales of $83.9 million for the 3 months ended February 28, for bottom-line growth of 385.6% while sales shrunk 2% compared with the same period during the previous year.

Earnings per share were ahead of the 19¢ consensus on Wall Street, while sales fell short of their $85.2 million expectations.

“Our third quarter results demonstrate continued execution against our operational goals as evidenced by meaningful gross margin expansion and strong profitability. Revenue growth remains negatively impacted by competitive headwinds in our venous and PICCs product lines, but we continue to believe that our ongoing portfolio evaluation and reshaping efforts will drive long-term sustainable top-line growth. We remain committed to creating value through both organic efforts and M&A as we continue transforming AngioDynamics into a dynamic leader in our industry,” prez & CEO Jim Clemmer said in a press release.

AngioDynamics reaffirmed earlier released guidance for the 2018 fiscal year, expecting to post net sales between $345 million and $350 million, with adjusted earnings per share between 70¢ and 74¢.

Shares in AngioDynamics have fallen 7.6% so far today, at $15.59 as of 10:21 a.m. EDT.

The post AngioDynamics shares down on fiscal Q3 sales miss appeared first on MassDevice.

from MassDevice https://ift.tt/2J5Nomy

LivaNova wins expanded CE Mark labeling for Bicarbon aortic valve

LivaNova (NSDQ:LIVN) said today it won expanded CE Mark labeling for its Bicarbon aortic heart valves, now cleared for use with low-dose anticoagulant therapy.

The new approval clears low risk patients who’ve received a Bicarbon aortic valve implant to be targeted using a lower international normalized ratio measurement of blood coagulability, allowing for a lower-range level of anticoagulant medication therapy, the London-based company said.

“When choosing a mechanical valve, patients look for a treatment option which lasts for life. The lower INR range approval for LivaNova Bicarbon Aortic Valves means patients now have a greater choice when selecting a mechanical prosthesis, with the freedom to enjoy a more active, confident lifestyle,” LivaNova cardiac surgery biz GM Alistair Simpson said in a press release.

The expanded indication was supported by results from the company’s Lowering-IT trial of the valve, which reported that patients experienced a 60% reduction in risk of bleeding.

“Our experience from the Lowering-IT trial with nearly 300 patients implanted with Bicarbon aortic valves maintained with an INR close to 1.9, with a median follow-up of over five years was presented at the American Heart Association 2017 meeting in Anaheim, California. Our study indicated that the proposed low-INR range between 1.5 and 2.5 (with 1.9 median target) is safe and feasible in low-risk patients after isolated aortic valve replacement with LivaNova’s Bicarbon prosthesis, resulting in similar thrombotic events and in a significant reduction of bleeding occurrence when compared to the conventional anticoagulation regimen,” study lead author Dr. Michele Torella of Naples, Italy’s Monaldi Hospital said in a prepared statement.

Yesterday, LivaNova said it launched a new feasibility trial of its Microburst Vagus Nerve Stimulation therapy system exploring its safety and effectiveness in treating patients with drug-resistant epilepsy.

The post LivaNova wins expanded CE Mark labeling for Bicarbon aortic valve appeared first on MassDevice.

from MassDevice https://ift.tt/2GTzZ0p

Pulmatrix prices $15m underwritten public offering

Pulmatrix (NSDQ:PULM) today priced an underwritten public offering of 23,500,000 units, including one share of common stock, one Series A warrant to buy one share of common stock and one Series B warrant to buy one share of common stock per unit.

The Lexington, Mass.-based company also gave underwriters a 30-day option to buy an additional 1,150,000 units. Pulmatrix reported that it expects to bring in approximately $15.2 million from the offering.

Get the full story at our sister site, Drug Delivery Business News.

The post Pulmatrix prices $15m underwritten public offering appeared first on MassDevice.

from MassDevice https://ift.tt/2J3BCcp

pSivida buys Icon Bioscience and rebrands as EyePoint Pharmaceuticals

With the help of $61 million from EW Healthcare Partners and a third-party investor, pSivida (NSDQ:PSDV) announced today that it acquired Icon Bioscience and its FDA-approved dexamethasone intraocular suspension designed to treat postoperative inflammation. The two companies combined and plan to do business as EyePoint Pharmaceuticals.

pSivida also landed a $20 million debt facility from SWK Holdings Corp., to help fund the Icon buyout and prepare for the commercial launch of Icon’s Dexycu product.

Get the full story at our sister site, Drug Delivery Business News.

The post pSivida buys Icon Bioscience and rebrands as EyePoint Pharmaceuticals appeared first on MassDevice.

from MassDevice https://ift.tt/2us3809

Zimmer Biomet joins US Dept of Energy sustainability, energy reduction program

Zimmer Biomet (NYSE:ZBH) said this week it will participate in the US Dept. of Energy’s Better Buildings, Better Plants energy reduction programs as it looks to reduce its carbon footprint in the US and Puerto Rico.

In joining the program, the Warsaw, Ind.-based company committed to reduce energy intensity by 25% over the next 10 years, as well as reduce its water use.

Zimmer Biomet said it is already using tools from the program to establish an energy baseline, and will refine its 2020 sustainability plan to reduce energy costs and boost facility performance.

Future strategies include using renewable energy when available, LED lighting technologies, improved compressed-air systems and premium-efficiency motors.

“Zimmer Biomet recognizes that we all have a responsibility to be good stewards of energy, as evidenced by our 2015 goal to reduce our carbon footprint by 20% by 2020. This partnership will help us reach that goal and continue to reduce energy intensity over the long term. Partnering with the DOE and its subject matter experts will provide our global and local energy teams with a variety of resources to help us meet our sustainability goals and have a positive influence on our business performance. The program will provide us with new insights into cost-effective and proven strategies for reducing our carbon footprint while meeting internal quality requirements, occupant comfort and stakeholder expectations,” global operations & logistics senior VP Adrian Furey said in a prepared statement.

Earlier this month, Zimmer Biomet priced two upcoming offerings worth $750 million with proceeds slated to repay approximately $1.2 billion in outstanding senior notes due April 1, 2018.

The post Zimmer Biomet joins US Dept of Energy sustainability, energy reduction program appeared first on MassDevice.

from MassDevice https://ift.tt/2GfVDPw

InspireMD wins Peruvian nod for CGuard, MGuard

InspireMD (NYSE:NSPR) said yesterday it won regulatory approval from Peru’s Ministry of Health for its CGuard embolic prevention system and MGuard Prime.

The Israel-based company said it inked an exclusive distribution agreement with Peru-based medical device distributor Dispositivos Medicos E.I.R.L.

“We have been working closely with InspireMD in order to educate key opinion leaders and top hospital chains in preparation for marketing clearance, which we have now secured. The clinical data from both of these products is quite impressive and we expect our physicians to start using the products very quickly,” Dispositivos Medicos E.I.R.L. GM Maximiliano Arboleda said in a prepared statement.

InspireMD said that both it and Dispositivos Medicos collaborated to pursue regulatory approval for both the CGuard and MGuard devices in the country, and that sales on both will commence immediately.

“We are excited to officially launch our commercial efforts in Peru following an extensive regulatory review and approval by the Peruvian health authorities. The approval of both CGuard EPS and MGuard Prime in Peru is further recognition of the importance of our products and supports our expansion into Latin America. With a population of more than 30 million and solid GDP growth, Peru is an attractive market and Dispositivos Medicos E.I.R.L is a great partner, as it represents many of the leading global medical device manufacturers in Peru,” InspireMD chief commercial officer and EVP Agustin Gago said in a press release.

Last month, InspireMD said it pulled the trigger on a 1-for-35 reverse stock split.

The post InspireMD wins Peruvian nod for CGuard, MGuard appeared first on MassDevice.

from MassDevice https://ift.tt/2uuWUww

RTI Surgical touts SImmetry sacroiliac joint fusion study

RTI Surgical (NSDQ:RTIX) today released results from a study of its SImmetry sacroiliac joint fusion system, touting that it produces effective joint fixation with a reduced range of motion in the SI joint.

Results from the study were published in The Spine Journal, the Alachua, Fla.-based company said.

In the study, researchers compared two minimally-invasive techniques for placing primary and secondary threaded implants to compare effectiveness at stabilizing the SI joint. Investigators also explored the impact of removing the secondary implant on construct rigidity.

Data from the study indicated that the SImetry implants provided a 65-71% reduction in joint motion which was maintained after repeated loading, the company said.

“These results reinforce the effectiveness of the SImmetry System in aiding patients who suffer from chronic low back pain caused by SI joint dysfunction. The SImmetry System is the only minimally-invasive surgical procedure that promotes SI joint fusion through decortication, reducing the range of motion in all directions with only two implants,” prez & CEO Camille Farhat said in a press release.

RTI Surgical said it recently acquired the SImmetery system in efforts to invest in advanced spinal surgery innovations.

Earlier this month, RTI Surgical put black ink into the ledger for 2017 and pared its fourth-quarter losses in its earnings release.

The post RTI Surgical touts SImmetry sacroiliac joint fusion study appeared first on MassDevice.

from MassDevice https://ift.tt/2Gfytsh

LivaNova launches Microburst VNS drug-resistant epilepsy trial

LivaNova (NSDQ:LIVN) said today it launched a new feasibility trial of its Microburst Vagus Nerve Stimulation therapy system exploring its safety and effectiveness in treating patients with drug-resistant epilepsy.

The London-based company said that Dr. Rebecca O’Dwyer of Chicago’s Rush University Medical Center has enrolled the first patient in the trial, which aims to enroll a total of 40 patients at 15 US sites.

“At the Rush Epilepsy Center, we are very dedicated to research and advancing the field of epilepsy therapeutics for patients. It is an honor to have enrolled the first patient in the Microburst VNS Therapy Feasibility Study, and we look forward to the resulting impact it will have on this patient population,” Dr. O’Dwyer said in a press release.

The trial will consist of a cohort of 20 patients with primary generalized tonic-clonic seizures and a 20-patient cohort of patients with partial onset seizures, including complex partial seizures with or without secondary generalization.

Patients in the trial will be monitored for 15 months with a primary endpoint measuring the percent change in seizure frequency and stimulation-related adverse events as compared to a baseline. Brain activation in response to stimulation will be assessed using functional magnetic resonance imaging.

Secondary endpoints in the trial include changes from the baseline in seizure severity, quality of life, anti-epileptic drug use, suicidality and adverse events.

“LivaNova is launching this study to enrich our understanding of epilepsy patient populations and the significant role VNS Therapy can play in the overall management of this disease. Through the Microburst feasibility study, we have the opportunity to evaluate a prospective new feature for VNS Therapy where stimulation is delivered in higher frequency bursts rather than gradual intervals,” LivaNova neuromod GM Edward Andrle said in a prepared statement.

Earlier this month, LivaNova said it launched a new trial of its Perceval sutureless aortic valve implant in China as it pursues Chinese Registration of the device.

The post LivaNova launches Microburst VNS drug-resistant epilepsy trial appeared first on MassDevice.

from MassDevice https://ift.tt/2Gi8D7e

Wright launches Invision ankle revision, Prophecy preoperative nav systems in US

Wright Medical (NSDQ:WMGI) last week announced the US launch of its Invision total ankle revision system and Prophecy preoperative navigation planning system.

The Memphis, Tenn.-based company touted the Prophecy preoperative navigation system as the first such system with patient specific instrumentation designed for ankle revision arthroplasty procedures.

“Revision of a failed total ankle arthroplasty remains a challenge. The ability to preoperatively plan out these cases and determine appropriate alignment based on the individual patient’s CT data will provide surgeons with an extra level of confidence that the implants will be positioned in the optimal alignment,” Dr. William McGarvey of the University of Texas Health Science Center said in prepared remarks.

Wright Medical said the Prophecy system won initial approval in 2012, and has been shown in clinical trials to help surgeons align ankle replacements, increase surgical efficiency and reduce operating room time and potentially reduce cost.

“The Invision Total Ankle Revision System with Prophecy Preoperative Navigation builds on Wright Medical’s commitment to providing physicians with innovative tools that lead to the best possible patient outcomes. Total ankle arthroplasties provide a unique set of challenges for our physicians and we are excited to be bringing this technology to market to see its success in action.  The launch of Invision with Prophecy expands our leadership in total ankle technology and marks our ability to best address the total ankle replacement continuum of care,” prez & CEO Robert Palmisano said in a press release.

Earlier this month, KFx Medical said it and Wright Medical agreed to dismiss patent litigation over rotator cuff repair patents between the companies and ink a licensing deal.

The post Wright launches Invision ankle revision, Prophecy preoperative nav systems in US appeared first on MassDevice.

from MassDevice https://ift.tt/2GgiG8M

Materialise touts FDA first in clearance of 3D printed anatomical model tech

Materialise said today it won FDA 510(k) clearance for its Mimis inPrint software designed for 3D printing anatomical models for diagnostic use, touting it as the first clearance of its kind.

The Belgian company said that last August, the FDA ruled that software designed to create files for 3D printing patient-specific anatomical models for diagnostic purposes would be labeled as class II medical devices, and that it is the first company to provide conforming software to create such models.

“510k clearance is an essential component to ensure quality and safety in the practice of anatomical modeling in hospitals. This milestone for Materialise serves as a benchmark for the clinical implementation of 3D printing for physicians creating 3D models at the point-of-care,” Dr. Frank Rybicki of the Ottawa Hospital said in a prepared statement.

The newly cleared Materialise Mimics inPrint software is designed for pre-operative planning and printing of physical models for diagnostic purposes including patient management, treatment and surgeon-to-surgeon communication.

“Materialise has nearly three decades of experience in developing certified medical solutions that create a better and healthier world. The FDA clearance for our Mimics inPrint software will support the adoption of 3D planning and printing in U.S. hospitals and the creation of point-of-care 3D printing facilities,” Materialise CEO Wilfried Vancraen said in a press release.

Last November, Siemens (NYSE:SI) Healthineers and Materialise announced a 3D printing deal looking to place Materialise’s Mimics inPrint 3D printing software in hospitals globally.

The post Materialise touts FDA first in clearance of 3D printed anatomical model tech appeared first on MassDevice.

from MassDevice https://ift.tt/2E1FJSQ

Bigfoot brings Series B total to $55m with new investment from Abbott

Reeling in an $18 million add-on to the $37 million Series B that it reported last year, Bigfoot Biomedical touted today that it has raised over $90 million in total funding since the Milpitas, Calif.-based company first launched.

Investments from Abbott (NYSE:ABT), which has an established partnership with Bigfoot, and other new and existing investors, brought the Series B round total to $55 million. The company said it plans to use its newly-acquired funds to support the development and clinical evaluation of its closed-loop automated insulin delivery system, Bigfoot Loop, and its connected insulin pen-based decision support system, Bigfoot Inject.

Get the full story at our sister site, Drug Delivery Business News.

The post Bigfoot brings Series B total to $55m with new investment from Abbott appeared first on MassDevice.

from MassDevice https://ift.tt/2GDNvYc

How medical device industry suppliers can save their clients money

[Image from Unsplash]

Count Spectrum Plastics Group (Alpharetta, Ga.) among the medical device industry suppliers adding capabilities and expertise in order to add value to what they provide their customers.

Long gone are the days when medtech contract manufacturers simply made orders to spec. As four recent case studies out of Spectrum highlight, it’s all about branching out and finding ways to save medical device companies money.

Here are four ways Spectrum has been able to up its game with customers in recent years:

1. Taking a lead on standards

A Spectrum Plastics Group company, formerly known in the market as Xeridiem Medical Devices, was an early leader in the Global Enteral Device Supplier Association (GEDSA) — an industry alliance seeking to address the fact that the same Luer connector was in use for several different medical tubing purposes. The resulting ISO 80369-3 standard spurred the innovation of a new connector under the trade name ENFit that is specific for enteral feeding. ENFit is meant to ensure that only devices intended for nutritional delivery connect with the corresponding tubing, preventing potentially deadly and costly situations.

Industry adoption for ENFit is at 25%, according to Spectrum, where company officials expect full adoption by 2020.

Get the full story on our sister site Medical Design & Outsourcing. 

The post How medical device industry suppliers can save their clients money appeared first on MassDevice.

from MassDevice https://ift.tt/2GgKSIp

Boston Scientific touts win in UK-based patent spat with Edwards Lifesciences

Boston Scientific (NYSE:BSX) said today it won a victory in a U.K.-based patent spat with Edwards Lifesciences (NYSE:EW).

The Marlborough, Mass.-based company said that the U.K. Court of Appeals dismissed an appeal from Edwards and upheld an earlier decision that its Sapien 3 infringes on a Boston Scientific patent.

In the decision, the appeals court found that all claims on the Boston Scientific patent were valid, the company said.

Boston Scientific added that it plans to appeal a U.S. Patent Office Inter Partes Review finding that certain claims of a US patent related to transcatheter heart valves owned by Boston Scientific asserted against Edwards are invalid.

Earlier this month, Edwards announced that the US Patent and Trademark Office had ruled in their favor in the patent spat.

“We are pleased with another positive ruling from the European courts which further substantiates our intellectual property. We see the U.K. court’s decision as an important validation of our patents and supports our goal to bring differentiated solutions to patients suffering from severe and symptomatic aortic valve stenosis,” corporate secretary, GC and senior VP Desiree Ralls-Morrison said in prepared remarks.

Yesterday, Boston Scientific said it is joining the Mayo Clinic and the University of Minnesota in backing startup accelerator Gener8tor as it launches a medtech focused incubator in Minneapolis.

The post Boston Scientific touts win in UK-based patent spat with Edwards Lifesciences appeared first on MassDevice.

from MassDevice https://ift.tt/2GkZrLf