dimarts, 30 de juny del 2015

BSN Medical buys FarrowMed

BSN Medical buys FarrowMedBSN Medical said yesterday it has acquired elastic short-stretch compression garment maker FarrowMed.

The acquisition will expand BSN’s product line which is focused on the management of lymphatic and venous disorders, the Hamburg, Germany-based company said.

“This acquisition benefits BSN and our customers alike, as we are now able to offer more comprehensive management solutions to the growing patient population suffering from lymphoedema and wounds associated with chronic venous insufficiency. We aim to build a leading position in lymphology. The combined product offering from BSN and FarrowMed fuels growth and is an important step towards becoming a one-stop provider of therapy solutions to the benefit of patients,” BSN CEO Dr. Guido Oelkers said in prepared remarks.

BSN will begin to offer elastic short stretch compression wraps for treating lymphatic and venous disorders with the acquisition, including FarrowMed’s Farrowrap, the company said. The acquisition will also expand BSN’s market presence in the U.S., the company added.

“We focus our efforts on creating innovative problem solving solutions, which will provide cost-effective care and improve the lives of patients with lymphoedema and venous disease. We are very proud of what we have been able to accomplish as a small and focused company. We are excited to join BSN, as the company has a fantastic history of clinical excellence and this step will help drive further clinical innovation. BSN’s global presence makes it possible for our compression garment technology to now be made available to lymphoedema patients worldwide,” FarrowMed CEO Dr. Wade Farrow said in a press release.

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Imthera Medical opens $10m financing round

Imthera Medical opens $10m financing roundImThera Medical has opened for a $10 million equity financing round, according to an SEC filing posted last Friday.

The company’s flagship product is the Aura6000, an implanted hypoglossal nerve stimulator for sleep apnea that won FDA investigational device exemption in November 2014.

ImThera Medical has already raised $2.7 million from 29 investors, according to the SEC filing from the San Diego, Calif.-based company. No investors were named, and the company has not commented on the funding round.

The Aura6000 system uses 2 implanted components, 1 near the collarbone and 1 in the upper neck. The therapy uses a multi-contact electrode and programmable pulse generator to improve muscle tone in certain tongue muscles to help control upper airway flow and reduce or eliminate sleep apnea, according to the company’s website.

In May, ImThera said the 1st 2 U.S. patients were successfully implanted with the device for a clinical study of its Aura6000 system.

ImThera’s Aura6000 has already received CE Mark clearance in Europe and is currently commercially available in certain markets outside the U.S., the company said.

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Inari Medical closes $12.4m Series B

Inari Medical closes $12.4m Series BInari Medical said today it closed a $12.4 million Series B financing round to fund continued product development and studies of its FlowTriever thrombectomy system.

The round was led by members of the board of directors and returning Versant Ventures and U.S. Venture Partners, as well as several medical device industry veterans, the Irvine, Calif.-based company said.

“We are very pleased to complete this financing with the support of new and existing investors. These funds will allow us to significantly enhance company value with continued product improvements and clinical studies that demonstrate the value of the FlowTriever retrieval/aspiration system in several markets with important unmet needs,” CEO Bill Hoffman said in a press release.

The FlowTriever is an FDA approved catheter-based thrombectomy device designed to remove clots in the peripheral vasculature, Inari Medical said. The device won FDA 510(k) approval in February and was used to treat its 1st patient in March, the company said.

“Inari’s approach to emboli retrieval is novel.  It provides the interventionalist with a tool that can substantially reduce the need for thrombolytics, which carry unacceptably high risk for many patients,”co-founder and chairman Bob Rosenbluth said in prepared remarks.

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MassDevice.com +3 | The top 3 medtech stories for June 30, 2015

plus3-1x1

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. EnteroMedics registers for $15m follow-on

MassDevice.com news

EnteroMedics registered for a follow-on offering that could bring in as much as $15 million for its Maestro obesity device.

St. Paul, Minn.-based EnteroMedics won FDA approval for the Maestro device in January 2015, following a mixed vote last year after the device failed to meet its efficacy endpoint in a clinical trial. It’s designed to use what EnteroMedics calls “vBloc therapy,” in which electrical pulses are used to block intra-abdominal vagus nerve signaling between the brain and stomach using a pacemaker-like device. Read more


2. Ethicon takes on ‘diabesity’ with $3m research program

MassDevice.com news

Johnson & Johnson’s Ethicon subsidiary said today that it’s dropping $3.2 million on a research program on the effects of early surgical intervention on obesity and Type II diabetes.

Cincinnati-based Ethicon said its “Time to Act on Obesity” program involves more than 20 clinical trials enrolling some 2,000 patients and investigator-initiated studies in 5 countries. Read more


1. AHA/ASA updates stroke treatment guidelines

MassDevice.com news

The American Heart Association/American Stroke Association said today that it updated its treatment guidelines for patients suffering from ischemic stroke to include endovascular treatments.

The decision supports the use of stent retrieval, and other thrombectomy devices, used to remove clots in patients who have obstructions in the large arteries supplying blood to the brain according to a new focused update published in the American Heart Association journal StrokeRead more

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Toshiba, Merge ink partnership deal

Toshiba, Merge ink dealMerge Healthcare (NSDQ:MRGE) said yesterday it formed a strategic partnership with Toshiba Medical Systems (TYO:6502) to offer both companies products together as a turnkey solution for customers.

The companies will partner to offer Merge’s cardiology PACS and hemodynamic monitoring with the Toshiba vascular x-ray systems, Chicago, Ill.-based Merge Healthcare said.

“For more than 15 years, the Toshiba Corporation has been a great partner with Merge and we are pleased to expand our partnership with Toshiba America Medical Systems to support their enterprise imaging initiative for a unified, interoperable cardiology management system. Being an enterprise imaging preferred partner is an honor, and we look forward to helping them achieve their objectives,” Merge CEO Justin Dearborn said in a press release.

Toshiba will offer customers the Merge Hemo, a real-time documentation tool for cardiac cath labs, as well as Merge Cardio, a web-enabled image and information system.

“At Toshiba, we understand our customers’ concerns when it comes to integrating IT solutions with imaging. Through this partnership, our customers will get a complete solution for accessing imaging information faster to improve the patient experience and our customers’ overall business,” Toshiba America medical systems veep of marketing Satrajit Misra said in a prepared statement.

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ViewRay reels in $50m debt round

ViewRayViewRay said today that it reeled in a debt round worth $50 million from CRG for its MRIdian MRI-guided radiation therapy device, a few months after scrapping an initial public offering that would have fetched $52 million at the midpoint.

The debt funding, from healthcare investment firm CRG, consists of an initial $30 million, 3-year, interest-only debt facility and another $20 million ViewRay can draw on once it meets unspecified milestones, the Cleveland-based company said.

In April ViewRay scrapped its planned IPO, after setting a range of $12 to $14 apiece for the 4-million-share flotation. The company had planned to trade under the “VRAY” symbol on the NASDAQ exchange.

The 1st $30 million is slated for the commercialization of the MRIdian device and to pay down $13 million in other debt.

“We are pleased to have the confidence and support of CRG, an investment partner renowned for its strategic investments in healthcare,” president & CEO Chris Raanes said in prepared remarks. “This loan facility provides the funding to support the next stage of commercialization and marks an important step in bringing the benefits of simultaneous MRI guidance and on-table adaptive treatments to radiation oncology professionals and the patients they serve.”

“We believe that MRI guidance is the future of treating cancer with radiation, and we are pleased to support ViewRay as the technology leader,” added CRG chairman Charles Tate. “The demonstrated clinical value of the MRIdian System at leading U.S. cancer centers gives us the confidence to invest in ViewRay’s business model.”

CRG has funded a number of medical device companies, including Navidea,  Ceterix and Astute Medical.

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SpineGuard wins clearance for Pediguard in China

SpineGuard wins clearance for Pediguard in ChinaSpineGuard  (EPA:ALSGD) said today that it received Chinese clearance to sell its Pediguard, a handheld surgical device designed to help guide proper spine screw placement.

The spine market in China is the 2nd-largest behind the U.S., the Vincennes, France-based company said, and is projected to be worth more than $1 billion by 2019.

“This regulatory clearance is the result of a diligent collaborative process with General Care International. It is a major milestone for SpineGuard and further validates the value of our DSG-based PediGuard device for making spine surgery safer,” CEO Pierre Jérôme said in a press release.

“The number of spine fusions is growing rapidly across China, and I believe there is a strong need for a simple smart device like PediGuard consistently ensuring safe and accurate placement of pedicle screws,” chief spinal surgeon Yong Qiu of the Nanjing University Hospital said in a prepared statement.

In September 2013, SpineGuard won Japanese Ninsho approval for its PediGuard device after going public on Europe’s Alternext exchange in April, drumming up $11.4 million.

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Lombard Medical debuts latest Aorfix stent graft

Lombard MedicalLombard Medical Technologies (NSDQ:EVAR) today announced the debut of its Aorfix Plus stent graft for endovascular repair of abdominal aortic aneurysms.

The Aorfix Plus, designed to treat larger-size AAAs, won 510(k) clearance from the FDA for the device in February.

Irvine, Calif.-based Lombard said the 1st clinical cases using the device were successfully completed at sites including the Loma Linda Veterans Administration Hospital in California and Blount Memorial Hospital in Merryville, Tenn.

“I find the stent graft extremely easy to deploy making the placement very predictable,” Blount Memorial’s Dr.Randy Reisser said in prepared remarks, noting that “the Aorfix stent graft works very well as compared to other devices and its broader size range now available will allow surgeons to deploy the device in a greater patient pool.”

“The launch of the Aorfix Plus stent graft further expands our ability to treat a wider range of patients,” added CEO Simon Hubbert. “Our aim is to provide the most effective on-label solution for the broadest AAA patient population – this clearance gets us closer to that goal. Based on patient data collected while conducting the premarket approval (PMA) study for Aorfix, we anticipate Aorfix Plus will enable us to treat up to 10 percent more patients with our family of devices. Aorfix’s unique indication to treat patients with aortic neck angulations up to 90 degrees, coupled with a comprehensive suite of sizing options, will allow an even greater number of patients with AAAs to benefit from treatment with Aorfix.”

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Zimmer & Biomet shift personnel after acquisition| Personnel Moves

Zimmer & Biomet shift personnel after acquisition| Personnel MovesZimmer (NYSE:ZMH), who acquired Biomet in a deal that closed this month, announced a series of personnel shifts upon the closure of the merger.

Zimmer CFO and senior veep James Crines has stepped down from his position to retire, effective August 3, to be replaced by former CFO and senior veep of BiometDaniel Florin, the company said. Prior to his position at Biomet, Florin was veep and corporate controller at Boston Scientific (NYSE:BSX) from 2001-2007.

Zimmer veep of finance and chief accounting officer Derek Davis has been lifted to veep of global integration, the company said. Zimmer global reconstructive division veep of finance Tony Collins will take the chief accounting position upon Davis’ exit.

Zimmer Asia Pacific president Stephen Ooi will also be stepping down to retire in December, the company said.

The combined company said it also expanded its board of directors from 10 members to 12, designating LVB directors Michael Michelson and Jeffrey Rhodes to the board.

 

 Second Sight taps ex-Volcano McGuire for CEO

Second Sight Medical (NSDQ:EYES) said it has tapped Volcano executive Will McGuire for its new CEO, with former CEO Dr. Robert Greenberg becoming chairman of the board of directors, replacing Dr. Alfred Mann, who will be chairman emeritus.

Read more

 Cochlear lifts NA prez Smith to CEO

Cochlear Ltd. (ASX:COH) said it will promote North American prez Chris Smith to CEO as current chief Chris Roberts is set to step down at the end of August.

Read more

 Cantel Medical taps ex-BSX exec, promotes another

Cantel Medical (NYSE:CMN) said it tapped ex-Boston Scientific senior veep David Hemink for president of its medivators division and will promote ex-Boston Scientific Michael Spicer to prez of Americas sales and global service division.

Read more

 Nevro adds Intersect ENT CEO to board

Nevro Corp. (NYSE:NVRO) said it has added Intersect ENT CEO Lisa Earnhardt to its board of directors with Bay City Capital’s Nathan Pliam stepping down.

Read more

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Centinel Spine claims 1st multi-level cervical indication

Centinel Spine Stalif C Ti today claimed it won the 1st multi-level indication for an interbody fusion device in the cervical spine, saying the FDA OK’d its Stalif C and Stalif C-Ti devices for then procedures.

“This is a valuable indication given the high incidence of multilevel degenerative disc disease in the cervical spine. We are excited to be the 1st company to receive this indication and to offer this benefit to our surgeon customers and their patients,” chairman & CEO John Viscogliosi said in prepared remarks. “This 1st-to-market indication is evidence that Centinel Spine will continue to be on the forefront of developing and enhancing spinal devices to meet the needs of our surgeon customers and their patients.”

YY-based Centinel’s Stalif C was already cleared for cervical single-level fusion with autograft or allogeneic bone graft, the company said.

“The FDA clearance provides both surgeons and patients with the assurance that Stalif C and Stalif C-Ti can be safely used to treat multilevel cervical spine pathologies,” added Dr. John Demakas of the Rockwood Neuroscience Institute in Spokane, Wash. “As an integrated interbody, the dynamic capability of the Stalif C-Ti screws allow the vertebral bodies to settle onto to the graft site. Combine this with compressive lag fixation and the osteoconductive advantage of the titanium coating, and Stalif C-Ti gives my patients the best opportunity for a solid fusion.”

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Teleflex recalls neonate manual resuscitator

Teleflex recalls neonate manual resuscitator

Teleflex (NYSE:TFX) said yesterday it is recalling its Hudson RCI Lifesaver neonate manual resuscitator.

The company said it began notifying hospitals and distributors of the recall on May 14.

The FDA labeled it a Class I recall, the most serious type of recall issued by the federal watchdog, indicating that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

The device is being recalled because “the intake port may be blocked, which can cause the bag to fail to fill,” Teleflex said.

A total of 9,333 items are being recalled, with 42 lots and 5 product codes affected, the company said.

Three complaints have been received and no patient injuries have been reported, but delays in treatment to obtain another resuscitator could potentially lead to adverse events such as hypoxia, the Wayne, Penn.-based company said.

In February Teleflex expanded a Class I recall for Maquet Servo 163 humidifiers, which are used to warm and humidify gases inhaled through the throat by patients who have undergone a tracheotomy.

The initial humidifier recall, issued Dec. 4, 2014, covered only 3 lots of the product distributed in Florida, Kansas, Michigan and West Virginia from June 2013 through November 2014. The recall was expanded Jan. 12 to include 6 lots distributed in those states during that time.

The recall was issued over reports that cracks had been discovered in some of the devices, which could interfere with patients receiving sufficient amounts of gases such as oxygen, according to the FDA.

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EnteroMedics registers for $15m follow-on

EnteroMedicsEnteroMedics (NSDQ:ETRM) today registered for a follow-on offering that could bring in as much as $15 million for its Maestro obesity device.

St. Paul, Minn.-based EnteroMedics won FDA approval for the Maestro device in January 2015, following a mixed vote last year after the device failed to meet its efficacy endpoint in a clinical trial. It’s designed to use what EnteroMedics calls “vBloc therapy,” in which electrical pulses are used to block intra-abdominal vagus nerve signaling between the brain and stomach using a pacemaker-like device.

Each share in the offering consists of a share of common stock, Series A warrants to purchase common stock and Series B warrants to purchase common stock, the company said. Canaccord Genuity is the book-runner and Craig-Hallum Capital Group is co-manager for the flotation, which has yet to price, EnteroMedics said.

The company said it plans to use the proceeds to further the commercialization for Maestro, which saw its 1st commercial implantation last month. The cash will also be used for clinical work, product development and other working capital and corporate needs, EnteroMedics said.

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St. Jude Medical launches OCT stenting trial

St. Jude MedicalSt. Jude Medical (NYSE:STJ) today said it’s launching the 1st trial comparing optical coherence tomography device with intravascular ultrasound or angiography during stenting procedures.

St. Paul, Minn.-based St. Jude said the 420-patient Ilumien III trial will compare treatment with its Optis Integrated and Ilumien Optis percutaneous coronary intervention optimization systems in treating patients with stable or unstable angina, silent ischemia or NSTEMI or STEMI heart attacks. Subjects will be randomized to undergo PCI with either OCT, angiography or IVUS, with a primary endpoint of the degree of minimum stent area achieved. The 1st patient, treated at the Columbia University Medical Center in New York, was randomized to the OCT arm of the study, the company said.

 

“We are excited about Ilumien III because this is the first randomized study of its kind to directly compare patient outcomes associated with guidance by OCT, IVUS or angiography during PCI,” principal investigator Dr. Ziad Ali said in prepared remarks. “Ilumien III is unique because we will be specifically assessing the utility of OCT in imaging guided PCI and gaining valuable insight into how OCT imaging can help shape patient care.”

 

“The launch of Ilumien III is an important step in assessing St. Jude Medical’s OCT technology and its ability to improve stent implantation over 1st-generation diagnostic tools,” added St. Jude’s chief medical officer Dr. Mark Carlson. “The study builds on important research showing the benefits of OCT imaging in supporting clinical decision making, and we’re excited to have this important trial underway.”

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UPDATE: Medical societies update stroke guidelines

UPDATED: Medical societies update stroke guidelines

A bevy of cardiac medical societies updated their guidelines for stroke treatment yesterday to take into account new devices and technology, including left atrial appendage occlusion devices, stent retrievers and thrombectomy devices.

The American College of Cardiology, Heart Rhythm Society and Society for Cardiovascular Angiography and Interventions have updated their guidelines to include the benefits of left atrial appendage occlusion for patients with atrial fibrillation.

The groups suggests that the use of LAA occlusion devices, such as Medtronic‘s (NYSE:MDT) Watchman device, may lower the risk of stroke in select patients. The societies recommended the treatment for patients who are contraindicated for or unable to take anticoagulation drugs, which they said is the standard of care.

“This document highlights the critical issues surrounding left atrial appendage occlusion therapies. We aimed to facilitate the alignment among patients and their families, primary care physicians, general cardiologists, and additional heart team members and procedural specialists. We also identified the need to collect robust clinical data on outcomes for patients who are treated with these devices in clinical practice, especially because in some cases, the evidence for some devices in use is sparse,” writing committee chair Dr. Frederick Masoudi of the University of Colorado Anschutz Medical Campus said in prepared remarks.

The medical groups said that they expected to see new devices for LAA occlusion and an increase in the use of the devices in the future, and supported a focus on data collection as their use grows.

The societies said the update was the first in a series that addresses new technology integration into the guidelines for patients with atrial fibrillation.

The American Heart Association/American Stroke Association said yesterday that it updated treatment guidelines for patients suffering from ischemic stroke to include endovascular treatments, such as stent retrievers and other thrombectomy devices.

The decision supports devices used to remove clots in patients who have obstructions in the large arteries supplying blood to the brain, according to a new focused update published in the American Heart Association journal Stroke.

The AHA/ASA said that optimal treatment still lies with the intravenous use of tissue plasminogen activator, used to break down clots, but recommends the use of retrieval devices in cases where obstructions continue after the medication has been administered.

“What we’ve learned in the last 8 months, from 6 new clinical trials, is that some people will benefit from additional treatment with a stent retrieval device if a clot continues to obstruct one of the big vessels after tPA is given,” update lead author Dr. William Powers of the University of North Carolina at Chapel Hill said in a press release.

The decision was based upon the results of randomized clinical trials published since 2013, when the last treatment guidelines were issued. These included 3 trials of Medtronic’s Solitaire stent retriever device and Penumbra‘s Mr Clean trial of its Ace64 aspiration thrombectomy device, the companies said.

“Since Medtronic’s invention of the first stent retriever in 2007, our commitment to fighting stroke has not wavered. We helped to bring the five global trials to bear that have proven this device can be a game changer in the treatment of stroke, reducing functional disability in patients. The AHA/ASA guidelines have validated our commitment to and belief in this technology, and we will work hard to make it accessible to as many stroke patients as possible,” Medtronic neurovascular business president Brett Wall said in a prepared statement.

“We are pleased that the American Heart Association/American Stroke Association updated their acute ischemic stroke treatment guidelines to support the endovascular treatment of stroke patients. This is another step forward for those patients who can benefit from mechanical thrombectomy as shown by the landmark Mr Clean study and subsequent confirmatory trials that support endovascular treatment over medical management alone,” Penumbra CEO Adam Elsesser said in a press release.

The update suggests a preference for stent retrievers over other mechanical thrombectomy devices, but adds that the use of other devices may be reasonable based upon a physician’s clinical judgement.

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Ethicon takes on ‘diabesity’ with $3m research program

Ethicon tackles obesityJohnson & Johnson’s(NYSE:JNJ) Ethicon subsidiary said today that it’s dropping $3.2 million on a research program on the effects of early surgical intervention on obesity and Type II diabetes.

Cincinnati-based Ethicon said its “Time to Act on Obesity” program involves more than 20 clinical trials enrolling some 2,000 patients and investigator-initiated studies in 5 countries.

“We know that metabolic disease has reached pandemic proportions, as nearly 30% of the world’s population is overweight or obese. We are calling our commitment, our rallying cry, It’s Time to Act on Obesity. And, if ever there’s a time – a tipping point, when we can make a difference – it’s now,” Ethicon chairman Michael del Prado said in prepared remarks. “Ethicon will continue working to reverse the trajectory of obesity by connecting the brightest clinical researchers and surgeons with our unparalleled science, economic insights and global reach to find long-term solutions.”

The program also includes studies on the economic impacts of bariatric and metabolic interventions, Ethicon said.

“The ultimate questions we’re always seeking to answer are: Who is the right patient, what is the right procedure, and is this the right time?” medical director for obesity & metabolic disease Dr. Elliott Fegelman said in prepared remarks. “In the U.S., the term ‘diabesity’ is gaining popularity because of the inextricable link between Type II diabetes and obesity. That’s the reverse of what we know to be true in Asia. For example, in China, they’re recording upwards of 114 million patients who have uncontrolled Type 2 diabetes, but develop it much earlier on the BMI curve, meaning they’re not as obese. We don’t see that same level of interdependence – that perceived cause-and-effect in Asia, between obesity and diabetes. These regional nuances, as we look across the U.S., Asia, Europe and Latin America, all require different and distinctive solutions, and that’s what our investment will help deliver.”

Ethicon said it’s looking to address a similar issue in India, where patients with uncontrolled diabetes also have lower BMI rates. In France, the program will aim to generate clinical and economic data to back guidelines for bariatric surgery. In Brazil, where patients can wait 7 years for bariatric and metabolic surgeries, Ethicon will study the cost and health impact of delayed treatment. The U.S. portion of the program will evaluate the durability of remission of co-morbidities like Type 2 diabetes after bariatric and metabolic interventions, the company said.

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Hong Kong regulators issue list of recognized standards for medical devices

Hong Kong regulators issue list of recognized standards for medical devices

By Stewart Eisenhart, Emergo Group

Regulators in Hong Kong have published a new list of recognized standards applicable to medical devices as the region moves toward more formal oversight of its device market.

The Hong Kong Medical Device Control Office’s (MDCO)list is intended as a reference for in-country representatives (Local Responsible Persons) in order to demonstrate safety and effectiveness of their manufacturers’ products.

The MDCO list includes standards from the International Standards Organization (ISO) and International Electrotechnical Commission (IEC). MDCO has included ISO 15223 for medical device symbols, but not EN 980, an older standard for device symbols.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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dilluns, 29 de juny del 2015

AHA/ASA updates stroke treatment guidelines

AHA/ASA updates stroke treatment guidelines

The American Heart Association/American Stroke Association said today that it updated its treatment guidelines for patients suffering from ischemic stroke to include endovascular treatments.

The decision supports the use of stent retrieval, and other thrombectomy devices, used to remove clots in patients who have obstructions in the large arteries supplying blood to the brain according to a new focused update published in the American Heart Association journal Stroke.

The AHA/ASA said that optimal treatment still lies with the intravenous use of tissue plasminogen activators, used to break down clots, but recommends the use of retrieval devices in cases where obstructions continue after the medication has been administered.

“What we’ve learned in the last 8 months, from 6 new clinical trials, is that some people will benefit from additional treatment with a stent retrieval device if a clot continues to obstruct one of the big vessels after tPA is given,” update lead author Dr. William Powers of the University of North Carolina at Chapel Hill said in a press release.

The decision was based upon the results of randomized clinical trials, such as Penumbra‘s Mr Clean trial, published since 2013 when the last treatment guidelines were issued.

“We are pleased that the American Heart Association/American Stroke Association updated their acute ischemic stroke treatment guidelines to support the endovascular treatment of stroke patients. This is another step forward for those patients who can benefit from mechanical thrombectomy as shown by the landmark Mr Clean study and subsequent confirmatory trials that support endovascular treatment over medical management alone,” Penumbra CEO Adam Elsesser said in a press release.

The update suggests a preference for stent retrievers over other mechanical thrombectomy devices, but adds that the use of other devices may be reasonable based upon a physician’s clinical judgement.

The post AHA/ASA updates stroke treatment guidelines appeared first on MassDevice.



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MassDevice.com +3 | The top 3 medtech stories for June 29, 2015

MassDevice.com +3 | The top 3 medtech stories for June 29, 2015

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. Medtronic wins aortic valve patent spat with inventor

MassDevice.com news

Medtronic won a patent infringement dispute over its CoreValve aortic valve replacement with inventor Dr. Troy Norred, according to legal filings.

The district court case, filed by Norred in 2013, had received stays until an inter partes review could examine the patent case, according to legal filings. The 3 judge panel reviewing the case found 7 of Norred’s claims were unpatentable, upholding Medtronic’s challenge to the patent. Read more


2. Integra LifeSciences picks up TEI Biosciences, TEI Medical for $312m

MassDevice.com news

Integra LifeSciences said that it agreed to acquire TEI Biosciences and sister company TEI Medical for $312 million in cash in a bid to expand its footprint in reconstructive surgery and regenerative wound care.

The deal, expected to close during the 3rd quarter, brings TEI’s PriMatrix dermal repair scaffold and a 125-member sales force under the Integra umbrella, that Plainsboro, N.J.-based company said. TEI is based in Waltham, Mass. Read more


1. Ex-OtisMed CEO Chi draws 2 years

MassDevice.com news

The former CEO of Stryker subsidiary OtisMed, Charlie Chi, drew a 2-year prison sentence after pleading guilty to distributing knee replacement surgery cutting guides without FDA clearance, the safety bureau and federal prosecutors said.

Stryker inherited the beef when it acquired OtisMed in 2009, later offering to pay $33 million to settle the federal investigation. The misconduct occurred before the acquisition and “without Stryker’s prior knowledge or acquiescence,” the prosecutors said. The company agreed to pay $80 million late last year to settle its part of the case, with Chi pleading guilty on 3 counts. Read more

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DoJ closes Abiomed Impella 2.5 investigation

DoJ closes Abiomed Impella 2.5 investigationAbiomed (NSDQ:ABMD) said today that the U.S. Department of Justice has closed an investigation into the marketing of the company’s Impella 2.5 heart pump without taking any enforcement action.

The investigation began in October 2012 when Danvers, Mass.-based Abiomed said it was informed that the U.S. Attorney’s Office of the District of Columbia had initiated an investigation.

The DoJ informed the company it was seeking internal documents relating to Abiomed’s marketing and labeling of the Impella 2.5, the company said. Abiomed said it cooperated fully with the inquiry.

“We are pleased that the Department of Justice has chosen to close its investigation without pursuing any further action and that this matter is now behind us.  We have always remained steadfast in our integrity and our commitment to putting our patients first,” CEO Michael Minogue said in a press release.

The Impella 2.5 is a percutaneous “micro heart pump” with integrated motor and sensors, which the company bills as the world’s smallest heart pump.

Abiomed won pre-market approval from the FDA for its flagship Impella 2.5 in March, after the FDA’s Circulatory Devices panel recommended in late 2012 that percutaneous cardiac assist devices be subject to the FDA’s most stringent PMA protocol. The pump had been allowed on the U.S. market via the FDA’s less-stringent 510(k) clearance protocol.

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Bard touts publication of Lutonix study in NEJM

Bard touts publication of Lutonix study in NEJMC.R. Bard (NYSE:BCR) said last Thursday that a 2-year study of its Lutonix drug-coated balloon catheter was published in The New England Journal of Medicine.

The 2-year Levant 2 study data showed non-inferiority of the device and a trend towards superiority, compared to standard percutaneous transluminal angioplasty, in the treatment of peripheral artery disease, the company said.

“We want to thank the investigators involved in the Levant 2 trial for their authorship of this ground-breaking study. Publication of the study results in The New England Journal of Medicine demonstrates the high quality of the trial and the importance of the results,” CEO Timothy Ring said in a press release.

“The publication of these data in the prestigious New England Journal of Medicine reinforces not only the superior results for Lutonix 035 DCB compared to standard PTA, but also the rigor of the clinical trial. This should provide additional confidence to clinicians looking to use a drug coated balloon in treating PAD in the femoropopliteal arteries,” Bard senior veep of science, technology & clinical affairs Dr. John DeFord said in a prepared statement.

The study, released earlier this month, showed 78.7% composite safety scores at 2 years, primary patency of 58.6%, an 82% rate of freedom from target lesion revascularization and a 6.9% rate of death.

“Levant 2 followed a rigorous blinding protocol, which was designed to reduce bias in the results. In addition to superiority in primary patency, the paclitaxel-coated balloon used in the study also demonstrated sustained improvements in Rutherford category from baseline to 12 months, and improved patient-reported walking distance scores,” principal investigator Dr. Kenneth Rosenfield of Boston’s Massachusetts General Hospital said in prepared remarks.

Earlier this month, Bard said that the U.S. Centers for Medicare and Medicaid Services had improved the payment for Bard’s Lutonix drug-coated balloon catheter through the Medicare hospital outpatient prospective payment system.

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