dilluns, 3 de juliol del 2017

Abiomed touts survival benefits in Impella 2.5 cardiogenic shock PCI treatment study

Abiomed

Abiomed (NSDQ:ABMD) today released results from a study of its Impella 2.5 heart pump examining the use of the device in patients with acute myocardial infarction complicated by cardiogenic shock, touting survival benefits associated with the device.

Results from the Danvers, Mass.-based company’s study were published in the Journal of Interventional Cardiology.

Data from the 36-patient retrospective study came from real-world outcomes with the Impella 2.5 during percutaneous coronary interventions on unprotected left main coronary arteries, Abiomed said. The study aimed to analyze whether the initiation of hemodynamic support before PCI would improve survival compared to support post-PCI.

Results indicated that patients treated with the Impella pre-PCI had survival rates of 55% at discharge and 48% at 30-days post discharge, versus 19% and 13% respectively for those treated post-PCI, Abiomed said.

“Patients with cardiogenic shock complicating an acute myocardial infarction due to an unprotected left main coronary artery culprit lesion are some of the sickest and most clinically challenging patients admitted in the cath lab. Our data suggests that early placement of Impella before PCI is vital to survival,” study 1st author Dr. Perwaiz Meraj of Northwell Health said in a press release.

Abiomed said the data supports prior data showing percutaneous heart pumps improved survival in cardiogenic shock patients.

“We commend Dr. Meraj and his coauthors on this application of real-world evidence. We are pleased that this adds to the body of research showing the benefit of placing Impella early and before PCI in the setting of cardiogenic shock,” chief medical officer Dr. Seth Bilazarian said in a prepared statement.

In May, Abiomed said it launched a 3rd generation Impella CP heart pump, touting new features and improved performance with the new model.

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MassDevice.com +5 | The top 5 medtech stories for July 3, 2017

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Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.

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5. BD extends Bard note exchange offering again

MassDevice.com news

Becton Dickinson said today is once again extending its exchange offering for up to $1.1 billion in outstanding C. R. Bard notes from July 3 to August 1.

The company is offering exchanges for approximately $500 million for 4.4% Bard note due 2021, $500 million for 3% notes due 2026 and $149.8 million in 6.7% notes due 2026. Read more


4. Abbott wins Health Canada nod for FreeStyle Libre glucose monitor

MassDevice.com news

Abbott said today that its FreeStyle Libre glucose monitoring system won Health Canada approval for adults with diabetes.

The company’s disposable glucose monitoring device is worn on the back of the upper arm and senses glucose using a small filament that is placed under the skin. Every scan includes a real-time glucose reading, as well as an 8-hour snapshot of blood sugar data. Read more


3. Second Sight Medical wins expanded CMS coverage for Argus II

MassDevice.com news

Second Sight Medical said today its Argus II retinal prosthesis system won expanded reimbursement coverage from the Centers for Medicare and Medicaid Services in 11 additional states and the District of Columbia.

With the expansion, the Sylmar, Calif.-based company said it’s Argus II device is now reimbursable in 7 of the 12 Medicare Administrative Contractor jurisdictions, covering the device in a total of 28 states, 2 territories and D.C. Read more


2. DeviceTalks: Big data, virtual reality and the connected brain in medtech

MassDevice.com news

The future of medical technology could involve artificial intelligence, virtual reality and even direct connections to the human brain. A panel at DeviceTalks, lead by Worrell Design’s director of advanced development, Derek Mathers, discussed how technological developments like Amazon’s Alexa and the accumulation of big data could shape future trends in medtech.  Read more

 


1. Medtronic nearing resolution on Infuse suits

MassDevice.com news

Medtronic is closing in on a resolution to the long-running legal battles over its Infuse bone-growth protein designed for back surgeries, according to an SEC filing posted last week.

The Fridley, Minn.-based company said that it is approaching agreements to settle approximately 6,000 cases against it which asserted personal injury claims due to the bone graft product in an SEC filing. Read more

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GSK inks deal for AI-driven drug discovery

ExscientiaExscientia inked a drug discovery collaboration with GlaxoSmithKline (NYSE:GSK) that could bring the Scotland-based company up to $37.5 million.

As a part of the deal, Exscientia plans to use its artificial-intelligence platform to discover small molecules for up to 10 disease-related targets, as chosen by GSK.

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

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Smith & Nephew inks wound care collab R&D deal with Univ. of Hull

Smith & Nephew

Smith & Nephew (NYSE:SNN) said today it inked a collaborative research & development deal with the University of Hull to develop new approaches to advanced wound care.

The company said that the deal will create “one of the world’s largest wound care research clusters” and includes a 5-year framework and a co-investment of approximately $3.9 million (£3 million).

“We are thrilled that the University of Hull shares our passion for the importance of advancing the science of wound care. Pioneering innovation is a strategic priority for Smith & Nephew. This partnership will combine the brightest minds with the finest R&D facilities available with the aim of better supporting healthcare professionals in the advanced treatment of wounds, which is an area of significant unmet medical need and a substantial cost to healthcare systems. There will be opportunities for students and employees to interact on a daily basis to share knowledge, best practice and support our ambitious R&D pipeline. Combine that with the scale of scientific specialities that is based here, then this partnership is a truly exciting prospect,” Smith & Nephew research & innovation VP Stewart McKinlay said in a prepared statement.

The collaborative deal will be supported by Smith & Nephew’s new R&D center in Hull, UK, as well as the University of Hull’s new Health Campus, which the company said would be open this summer.

“Britain is a global leader in medical technology innovation. Partnerships such as this between Smith & Nephew and University of Hull further strengthen our position at the forefront of global medical research and development. Creating one of the largest wound care clusters in the world is a huge vote of confidence in the UK as a whole and Hull in particular, as we build a ‘global Britain’ with pioneering medical technology at its heart,” local MP Emma Hardy said in a prepared release.

As part of the partnership, Smith & Nephew said it would extend the use of its facilities to Wound Care Cluster students through workshops and by providing industrial placement supervisors.

“This partnership goes to further strengthen our links with industry at the same time as creating a global hub for pioneering new approaches in this field. By combining the considerable expertise we have at the University with those at Smith & Nephew, we will drive research which will help to position ourselves as global leaders in this field,” Univ. of Hull research & enterprise pro-vice chancellor Dr. David Richards said in a press release.

“I am delighted by the establishment of this exciting new multi-disciplinary wound care cluster. This venture brings together a team of experts from across the University and builds upon our existing links with a world-leader in advanced wound management. This exciting partnership will ultimately deliver significant patient benefits,” Univ. of Hull wound healing research group head Dr. Matthew Hardman said in prepared remarks.

Last week, Smith & Nephew said it added a total knee arthroplasty application to the Navio handheld robot-assisted platform.

The European Union’s largest orthopedics player said the Navio system can be used with its Journey II, Legion Primary and Genesis II total knees. Smith & Nephew acquired Minnesota-based Blue Belt Technologies – Navio’s original maker – in January 2016 for $275 million.

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Ipsen wins approval for gastroenteropancreatic neuroendocrine tumor drug

IpsenIpsen (EPA:IPN) said today that Teijin Pharma Ltd. won approval from the Japanese Ministry of Health, Labor and Welfare for Ipsen’s Somatuline as a therapy for gastroenteropancreatic neuroendocrine tumors.

The subcutaneous drug was approved in Japan in 2012 for the treatment of acromegaly and pituitary gigantism.

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

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DeviceTalks: Big data, virtual reality and the connected brain in medtech

DeviceTalks Minnesota medtech leadershipThe future of medical technology could involve artificial intelligence, virtual reality and even direct connections to the human brain. A panel at DeviceTalks, lead by Worrell Design’s director of advanced development, Derek Mathers, discussed how technological developments like Amazon’s Alexa and the accumulation of big data could shape future trends in medtech. 

Wielding big data for innovation

Big data – the latest buzzword in health IT – could help usher in a new era of precision medicine and disease management, according to a panel of pharma and medtech experts at this year’s DeviceTalks in Minnesota.

Lisa Shafer, senior director of new devices and bioelectronics at Teva Pharmaceuticals (NYSE:TEVA), said that the generic drugmaker uses big data to identify new ways of repurposing its stockpile of medicine and better manage disease.

Other companies, like Smiths Medical, are incorporating big data with their drug pumps to monitor patients and make sure they’re not double-dosing. Rob Rajalingam, the VP and GM of the company’s vascular access division, added that the healthcare group is leveraging data analytics to identify the cause of hospital-acquired infections.

“It’s so multi-variable, it’s really well-suited to big data,” Rajalingam said.

Companies don’t need to have the technological capabilities internally to benefit from big data, according to Boston Scientific’s Bryan Clark.

“Analyzing big data through partnerships really offers us a great opportunity to identify where there may be gaps to better care, and let those gaps be opportunities for us to go again and to uncover new solutions,” he said.

Stephanie Board, VP of R&D delivery system engineering at Abbott (NYSE:ABT), explained that data analytics can be useful for more than just product development – big data could help companies optimize their chosen patient populations for clinical trials.

Google, Apple and Amazon – Silicon Valley enters medtech

It’s no secret that Google and Apple are interested in becoming major players within medtech. Between Google’s Project Baseline and Apple‘s (NSDQ:AAPL) rumored attempts to turn the iPhone into a centralized databank for healthcare, Silicon Valley could either deal a competitive blow to healthcare companies or offer major partnership opportunities.

“We hear enough about Google and Apple, and what they could do in healthcare, but a lot of it sometimes seems like smoke and mirrors because we haven’t seen a lot of traction in it yet,” Mathers said. “But one company that’s coming even closer than either of those in terms of logistical capabilities is Amazon.”

Mathers pointed out that Amazon (NSDQ:AMZN) has already begun working with medtech – in May, Merck (NYSE:MRK) announced that it partnered with Amazon to use the same deep learning technologies that power Amazon Alexa to develop solutions for patients with diabetes.

Clark added that in the same ways that Amazon has revolutionized how people shop for clothes and household items, it could one day do the same for pharmaceuticals.

Other unconventional companies might join the healthcare effort, too, according to the panel.

“Uber has got everybody’s attention,” Clark said.

How gene editing could change disease treatment

Editing genes using technology like CRISPR-Cas 9 could fundamentally alter the way we treat disease, the panel said. Mathers pointed out that researchers in China have already brought CRISPR-Cas9 into human trials and that cancer-related trials are on schedule for the US and China through 2018.

Shafer added that gene editing can help create relevant models of disease for researchers. But there is a lot of work to be done in order for medtech to embrace the technology.

“Not only does it have to get to the cell, it has to get to the right region of the body because it needs to be more targeted, otherwise it can bring about significant side effects thanks to a lack of specificity,” Shafer said. “So we need collaboration between pharma and tech and device companies to actually sell this and make it useful for therapy.”

Mathers described a mouse study that used CRISPR-Cas9 as a therapy to correct blindness. It was successful, but it came with serious problems – it caused a number of nucleotide malfunctions and resulted in over 100 unintended deletions and insertions, Mathers said. All 3 of the mice involved in the study died of different types of cancer in the weeks following the study.

“I think if we don’t understand what the mutations are and how to counteract those mutations, then we’re not ready to go into any humans,” Board said. “Now, on the flip-side of that, if somebody already has cancer and they’re going to die anyway, maybe that is where we need to take it and give them some other options for treatment.”

“But what we need to remember is that anything like this, anything major, as innovative as this is in terms of healthcare, it takes a long, long time to bring it to market, and it takes a lot of research,” Rajalingam added.

Why hospitals are adopting virtual reality 

Some healthcare groups are beginning to use seemingly futuristic technology like virtual reality to evaluate a device’s usability or calm young patients during procedures.

“What we’re seeing is a lot of our hospital partners are using it. So, if you visit a pediatric oncology ward, you need to draw blood from kids multiple times a day, sometimes multiple times in one setting, given the failing rates of some of the technology,” Rajalingam said. “It sounds simple but it has profound impact on the ease of administering that treatment.”

Adoption of high-tech solutions like virtual reality is largely driven by patient outcomes, Rajalingam explained, but Medicare is also influencing the decision to incorporate VR since it is adjusting reimbursement rates based on patient satisfaction scores.

Shafer added that she sees potential in using VR to stimulate a patient’s visual senses and distract them from pain, potentially reducing the need for painkillers that come with scary side effects.

“That sounds like a really inexpensive therapy that isn’t so addictive,” she said.

Patients aren’t the only people that could benefit from VR in healthcare – surgeons could practice complicated procedures in an atmosphere that mimics the operating table.

“We train pilots with the most crazy possible failure modes in VR, and yet our own surgeons have to use data that is nonresponsive or a surgical simulator that costs six figures,” Mathers said.

As companies begin incorporating high-tech solutions into their devices or medical practices, they need to keep patient preference in mind, Rajalingam added.

“One of the things we need to keep in mind is when we’re building technology we’re not building it for the use, we should be building it with the user, with their input on it,” he said. “There’s a lot of hype around AR, VR, all this technology, and we see people try to push it everywhere they can, but we need to make sure we keep in mind who it’s for and really engage those people in the process.”

Integrating technology with patient care

“Unlocking the human brain and learning how to read and write our neural code is the single most consequential and exciting adventure in the history of the human race,” Mathers said. “Ever since the 1st computer came out in 1946 and started flashing, humans have gotten closer and closer to their technology. It went from computers in the home in the 80s, to in your lap, to in your pocket, to on your wrist, and now in labs in contact lenses and in your ear.”

Neuromodulation, directly targeting the human brain as a form of treatment, could represent a new way of providing therapy – one that is more than symptom management, according to the panel.

“This is probably the largest area for growth for us as a medical field right now,” Board said.

Between tools that give us access to the inner workings of the brain and devices that augment our reality, healthcare companies are moving towards a future of highly connected technologies. But in order for these solutions to be effective in serving patients, healthcare groups and technology companies need to work together, Shafer said.

“We’re working to solve healthcare solutions that impact both med-tech and bio-pharma, and yet we do not speak well together because we have fundamentally different languages,” she said. “A fundamental barrier, an obstacle in using these technologies for healthcare, is converging our language and being in the room together.”

When companies work together to create smarter solutions, both patients and doctors reap the benefits, according to Rajalingam.

“Physicians today see relatively small numbers of patients, it could be 20 a year for a given surgery. Now you take the data from hundreds of thousands of patients and you aggregate that, and you use machine learning to actually predict outcomes and provide that information back to that surgeon or physician real time, they’re going to be able to make better decisions,” he said. “That machine learning, AI, isn’t doing the job for them, necessarily, but it’s certainly informing them.”

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Varian Medical wins FDA nod for Halcyon radiotherapy cancer treatment system

Varian Medical Systems

Varian Medical (NYSE:VAR) said today it won FDA 510(k) clearance for its Halcyon image-guided volumetric intensity modulated radiotherapy cancer treatment system.

The Palo Alto, Calif.-based company said its Halcyon IMRT system features improvements that make it more comfortable for patients and streamline operator’s workflow, only requiring 9 steps from start to treatment, down from 30 steps in legacy machines.

“We are proud that Halcyon has now received both 510(k) clearance and CE mark. With its human-centered and user-friendly design, Halcyon is engineered to revolutionize clinical workflow. These two clearances are very important milestones in the availability of this new system and advancing cost-effective cancer care worldwide,” Varian oncology systems biz prez Kolleen Kennedy said in a press release.

Varian Medical said the device is designed to handle “the majority” of cancer patients, including individuals with prostate, breast, head & neck and other forms of cancer. The system requires the company’s Eclipse 15.1.1 treatment planning software, which is currently pending 510(k) approval.

In May, Varian Medical said it won Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its ProBeam system designed for proton therapy.

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