By: Nina L. Hunter, Ph.D., and Robert M. Califf, M.D.

About a year ago, we shared with you our Combination Product Review, Intercenter Consult Process Study Report, which was developed by FDA’s Office of Planning. The report’s findings were derived from focus group studies with reviewers from FDA’s different Centers and included input from industry. Since then, we have built on foundational policies and processes to address many of the issues identified in the report.

The team has made tremendous progress toward the goal of modernizing the combination products review program by improving coordination, ensuring consistency, enhancing clarity, and providing transparency within the Agency as well as with all stakeholders. We are excited to share our progress with you now. The table below summarizes some key achievements from the past year, including publication of draft guidances, a variety of new processes, and a look at future goals.

As technologies advance across multiple fields, the distinctions that previously allowed combination products to be neatly categorized by FDA’s medical product centers are blurring or even vanishing.

Combination products account for a growing proportion of products submitted for review, and FDA will continue to pursue new approaches to collaboration that ensure safe, effective and innovative medical products are made available to patients as quickly as possible. Continued collaboration with you, our stakeholders, will be critical as together we continue to make progress in this important area.

We are still listening and have much more work to do!

This table summarizes key Combination Product Review Program achievements from the past year. Click on table for PDF version.

The PDF version of the table is also located here: combination-products-review-program

Nina L. Hunter, Ph.D., is FDA’s Associate Director for Science Policy in the Office of Medical Products and Tobacco

Robert M. Califf, M.D., is Commissioner of U.S. Food and Drug Administration

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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GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said last week that they filed a regulatory submission with the European Medicines Agency for the once-daily, triple-combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease. Last month, the companies submitted a new drug application for the inhaled therapy to the FDA for approval in the U.S.

The triple combination therapy is made up of 3 drugs – an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta-adrenergic agonist. The treatment is delivered once a day using GSK’s Ellipta dry powder inhaler. The regulatory submission is backed by clinical data that includes the phase III Fulfil study, which compared once daily FF/UMEC/VI with AstraZeneca‘s (NYSE:AZN) twice daily Symbicort Turbohaler in patients with advanced COPD. The triple combo therapy demonstrated improved lung function and statistically significant reductions in exacerbations.

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

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Israel’s Bonus Biogroup (TLV:BONS) said today that it successfully injected its lab-grown, semi-liquid bone graft into the jaws of 11 people in an early stage clinical trial evaluating bone loss repair. The company is presenting its results at the International Conference on Oral & Maxillofacial Surgery in Spain today.

The material is grown in a lab from a patient’s  own fat cells and then injected into the voids of problematic bones in the jaw. Over the course of a few months, the material hardens and merges with existing bones to fill out the jaw.

The transplant “was 100% successful in all 11 patients,” Ora Burger, the VP of regulation affairs, told Reuters. “Now we are going to conduct a clinical study in the extremities, long bones.”

CEO Shai Meretski previously founded Pluristem Therapeutics, an advanced Israeli biomedical company that works with stem cells.

“For the first time worldwide, reconstruction of deficient or damaged bone tissue is achievable by growing viable human bone graft in a laboratory, and transplanting it back to the patient in a minimally invasive surgery via injection,”Meretski told the news outlet.

The company has raised $14 million and plans to dual list on NSDQ soon.

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Sunovion Pharmaceuticals said today that it will soon begin enrollment for a Phase IV study of its anti-epileptic drug Aptiom with Empatica‘s Embrace watch. The Marlborough, Mass.-based company touted its study as the 1st to incorporate a wearable seizure device with an anti-epileptic drug into the design of a clinical trial for partial-onset seizures.

The Embrace watch is an investigational device that will be used in the study to detect and record partial-onset seizures as they are identified by patients or caregivers. Aptiom (eslicarbazepine acetate) is approved in the U.S. as a stand-alone or adjunctive therapy for partial-onset seizures.

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

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There is no clear cut-off age to stop breast cancer screening, according to new data from the largest-ever study on mammogram screening outcomes.

Data from the study was presented this week at the Radiological Society of North America’s annual meeting.

Age-based cutoffs for screenings have been a source of controversy for many years in the healthcare field. Results from the massive study, however, support guidelines that support making breast cancer screening decisions based on individual patients and health status over a specific age, according to study researchers.

Data in the study came from over 5.6 million mammogram screenings performed over 7 years between January 2008 and December 2014 and across 150 facilities in 31 U.S. states. Patient demographic data, mammography and biopsy results were considered in the analysis, with over 2.5 million women over 40 in the study.

A total of 4 standard performance metrics were used to evaluate the data at each age group, including cancer detection rate, recall rate, positive predictive value for biopsies and biopsies performed.

The mean rate of cancer detection was clocked at 3.74 per 1,000 patients, with a recall rate of 10%, positive predictive value of recommended biopsies at 20% and for biopsies performed at 29%. In considering age between 40 and 80 years, metrics showed a gradualte upward trend in terms of cancer detection rate and biopsy prediction rate, but a downward trend in recall rate.

“All prior randomized, controlled trials excluded women older than 75, limiting available data to small observational studies. There has been a lot of controversy, debate and conversation regarding the different breast cancer screening guidelines, even among major national organizations, over the past few years,” Dr. Cindy Lee of the University of California, San Francisco said in a prepared statement.

Study researchers indicated that the results supported the argument that individual personal health history and preferences should be used to inform whether or not to stop screenings.

“The continuing increase of cancer detection rate and positive predictive values in women between the ages of 75 and 90 does not provide evidence for age-based mammography cessation,” Dr. Lee said. “We know that the risk of breast cancer increases with age,. With the uncertainty and controversy about what age to stop breast cancer screening, we want to address this gap in knowledge using a large national database.”

• Samsung showcases FDA-cleared GM85 mobile digital radiography system
• GE Healthcare showcases industry-first technologies and digital solutions, focused on improving outcomes
• GE Healthcare unveils Freelium MRI technology
• Siemens Healthcare debuts robot-supported ARTIS pheno angiography system
• Toshiba Medical introduces premium ultrasound systems to enhance the clinical application of ultrasound
• Toshiba Medical’s new 3T MR speeds up neuro exams
• Toshiba Medical launches Aquilion One/Genesis edition
• Toshiba Medical’s fully integrated model-based iterative CT reconstruction wins FDA clearance
• Toshiba Medical launches MR system for efficient, standardized cardiac exams
• Toshiba Medical introduces new compact solution for advanced ultrasound imaging
• Toshiba Medical launches Xario 100 Platinum Series ultrasound tech for healthcare providers of all sizes
• NTT DATA Services announces partnership with AnatomyWorks for brain mapping algorithms
• NTT DATA Services announces partnership with Imbio for lung analytic algorithms for UCA imaging platform
• Doctors in Japan begin treating patients with Elekta’s Leksell Gamma Knife Icon
• BK Ultrasound, powered by Analogic, introduces bkFusion
• SyntheticMR introduces REMyDI, automatic measurement of myelin volume 
• Hologic to showcase breast screening and interventional solutions
• Clarius introduces pocket ultrasound
• Civco to introduce next-gen ultrasound guide
• Varian to showcase imaging components and software solutions
• Philips announces commercial availability of IntelliSpace unverisal data manager for healthcare enterprises
• Philips introduces new data-driven intelligent solutions connecting patients, practitioners & processes
• IBM unveils Watson-powered imaging solutions for healthcare providers
• Ziehm Imaging sets new standards for clinical benefits
• ProMedica to incorporate cardiology in its Sectra enterprise imaging solution
• Konica Minolta Healthcare introduces AeroDR HD high-res digital radiography detector
• Konica Minolta Healthcare introduces AeroRemote active monitoring capability
• iCAD to showcase use of artificial intelligence in medical imaging

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InGeneron said today that it landed a collaboration with the German Accelerator Life Sciences program, establishing an additional U.S. presence in Cambridge, Mass. The initiative is supported by the German Federal Ministry for Economic Affairs & Energy.

The GALS program will provide InGeneron with a group of mentors to help leverage its network within the industry and support the company’s U.S. presence and development in Europe. GALS will continue to support InGeneron as the company launches clinical development in the U.S. and expands its distribution network, the program said.

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

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Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals said today that its lidocaine patch, ZTlido, met primary and secondary endpoints in a pivotal study comparing the patch to Endo Pharmaceutical‘s Lidoderm patch. The data will be used to resubmit a new drug application to the FDA in mid-2017, the Malvern, Pa.-based company said.

The clinical trial evaluated Scilex’s 1.8% lidocaine patch to the 5.0% Lidoderm patch. The primary endpoint established comparative pharmacokinetics, while the secondary endpoint demonstrated bioequivalence between the 2 patches. ZTlido’s anhydrous patch contains only 36 mg of lidocaine, while Lidoderm holds 700 mg per patch.

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

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Transcatheter tricuspid heart valve repair device developer 4Tech said today it tapped former Thoratec interventional products GM Dr. Michael Ennen as its new prez & CEO, taking over for Carine Schorochoff who will stay on as an advisor and board observer.

Dr. Ennen worked with with Thoratec to take the company’s 1st catheter-based product through CE Mark approval in the European Union and commercialization in the region, as well as helping initiate an investigational device exemption trial for the device in the U.S.

“I’m delighted to welcome Mike to 4Tech as President and CEO. His track record of rapidly advancing breakthrough technologies, combined with his commercial experience, make him an ideal fit for the company. Mike brings deep cardiovascular expertise to the role, as well as tremendous leadership, insight and passion, which we are confident will help drive the success of the TriCinch System and the broader company. I also want to thank Carine for leading 4Tech into the strong clinical-stage position the company is in today and look forward to working with her as an advisor and a board observer,” board chair Bill Hawkins said in prepared remarks.

Prior to his time with Thoratec, Dr. Ennen served as chief scientific officer and held VP roles at ev3/Covidien and FoxHollow Technologies, 4Tech said.

“I am honored to be joining 4Tech, which I believe is positioned to create the category-defining percutaneous solution for tricuspid valve disease. 4Tech has advanced an innovative repair technology, and I am excited to build on that foundation and to accelerate our development efforts. Tricuspid regurgitation remains a significant unmet need, and I’m confident that the TriCinch System will meaningfully advance the portfolio of structural heart products and help patients worldwide,” Dr. Ennen said in a press release.

“This is the perfect time in the evolution of 4Tech for Mike to become its next President and CEO. Mike has consistently demonstrated a superior ability to amplify the commercial viability of medical technology. The 4Tech Team is looking forward to continuing to deliver on 4Tech’s mission under Mike’s leadership and is keen to welcome him and his family to Galway,” former-CEO Schorochoff said in a prepared statement.

Integra LifeSciences (NSDQ:IART) today announced a number of new appointments, lifting Robert Davis Jr. as orthopedics & tissue tech prez and corporate VP, tapping Dan Reuvers as corp VP and SSS prez and announcing that Glen Coleman will assume oversight of its international biz.

“These key leadership appointments reflect the depth and strength of our management team, enabling us to promote executives from within the company. Bob, Dan and Glenn are proven leaders who have demonstrated exemplary management capabilities over the years and a track record of accomplishments that have contributed to our strong business performance,” Peter Arduini said in a prepared statement.

SuperSonic Imagine said late last month it tapped Michèle Lesieur as its new prez & CEO, replacing Bernard Doorenbos. Lesieur previously held various positions at Royal Philips (NYSE:PHG), including Philips France prez.

“SuperSonic Imagine’s supervisory board is enthusiastic about Michèle Lesieur becoming the company’s President and CEO. Her expertise, her leadership and her significant experience in international healthcare companies made her the best candidate to run SuperSonic Imagine, thus replacing Bernard Doorenbos, who was interim President and CEO. Indeed, we would like to thank Bernard for his contribution. Under Michèle’s experienced leadership, the company will continue to implement its strategic plan, which consists in moving forward on its various markets by capitalizing on the highly-innovative nature of its Aixplorer ultrasound platform, launching new innovative features and products and developing new fruitful partnerships. Along with our dedicated employees and a strong leadership team now headed by Michèle Lesieur, the Supervisory Board is confident that the scene is set for resuming a strong development track going forward,” board chair Michael Brock said in a press release.

Skyline Medical said last week it tapped former exec chair Dr. Carl Schwartz as its new chief executive officer.

“I am very pleased to be assuming the CEO position at this exciting inflection point in Skyline Medical’s strategic plan. We have made a great deal of progress in recent weeks with the Streamway System, including new domestic sales, the approval by Health Canada and the expansion of our global distribution network. We expect to receive CE Mark for Streamway in the coming weeks, and have engaged GLG Pharma for distribution in the U.K. and Central Europe. With the promise of using Streamway for patient diagnostics and a joint venture directed at mobile operating rooms and other U.S. government purchasers, our growth prospects are better than they have been in a very long time. I look forward to executing our business plan with the support of a talented management team and of our board of directors,” Dr. Schwartz said in a prepared statement.

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Biotronik said today it enrolled the 1st patients in the BioInsight clinical study of its BioMonitor 2 heart monitor, which looks to investigate the feasibility implanting the BioMonitor 2 in office settings.

The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and 3 tesla strength.

“One of the benefits of BioMonitor 2 is the ease of the insertion procedure, which typically only takes a few minutes. In-office procedures can reduce patient’s and physician’s time, increase access to the device and reduce cost burdens for healthcare systems. Early insertion will likely also reduce the time needed for a conclusive diagnosis,” Dr. Raul Weiss of Ohio State University said in prepared remarks.

The company’s BioInsight study is a multi-center, prospective, non-randomized post-market study in which patients will be implanted with the BioMonitor 2 via an in-office procedure, and will be followed for 90 days to monitor possible adverse events, including infection and bleeding.

“BioMonitor 2 has been rapidly adopted by physicians, becoming a trusted, reliable solution to monitor for cardiac arrhythmias. There is a significant need for BioMonitor 2, and we want to ensure our physicians have the utmost confidence in their ability to deliver efficient patient care. The BioInsight study will assure physicians and patients that performing the insertion procedure in an office setting safely and effectively improves access to this critical diagnostic tool,” prez Marlou Janssen said in a press release.

Biotronik said it hopes to complete the trial in the 3rd quarter of 2017. The company won FDA clearance for the device in April, and won CE Mark approval in the European Union last August.

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NeuroPace today released 7-year follow-up data from a clinical trial of its RNS neurostimulation system designed to prevent epileptic seizures, touting an over-70% reduction in seizure frequency.

The company’s RNS system is a closed-loop brain-responsive neurostim system designed for preventing epileptic seizures, and has been approved by the FDA as adjunctive therapy to treat partial onset epilepsy in patients who are non-responsive to medication.

Data from the study was presented this week at the American Epilepsy Society’s meeting in Houston, the Mountain View, Calif.-based company said.

Follow-up data indicated a median reduction in seizure frequency of 72% at 7 years. At 7-years, 25% of patients reported a seizure reduction of greater than or equal to 93% for any 3 month period in the year, the company said.

A total 29% of patients in the trial reported experiencing 1 or more 6-month period free from seizures, according to a press release.

Clinical trial patients are continuing to be treated in an ongoing long-term treatment study, NeuroPace said, which is an ongoing, multi-center prospective open-label study for participants in either a feasibility or randomized controlled trial of the RNS system.

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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. FDA clears BrightWater Medical’s ConvertX nephroureteral stent

Ureteral medical device company BrightWater Medical said today it won FDA 510(k) clearance for its ConvertX nephroureteral stent system designed for treating ureteral obstructions.

The ConvertX System is designed as a single device intended to replace a series of devices and procedures used to treat severe obstructions of the ureter. Traditional interventions require an implanted nephrostomy catheter to externally drain urine and a second procedure to implant a nephroureteral stent to circumvent blockage. Read more

4. Teleflex puts up $1B for Vascular Solutions

Teleflex said today it will pay approximately $1 billion to acquire Vascular Solutions.

Through the deal, Teleflex will pick up all outstanding shares of Vascular Solutions at $56 per share, in cash. Boards of both companies have approved the deal, which is expected to close during the 1st half of 2017. Read more

3. Echo Therapeutics faces uncertain future in whistleblower case

Echo Therapeutics said today that its future may be in jeopardy after getting hit with a restrictive injunction related to a whistleblower case alleging securities violations, theft of trade secrets and more.

The company said it is facing a case in the U.S. District Court for Southern New York related to “various violations of the securities laws, theft of trade secrets, breach of contract and breach of fiduciary duty,” in a regulatory filing posted today. Read more

2. PTAB tosses out Covidien patent in surgical shears spat with J&J’s Ethicon

The Patent Trial and Appeal Board has thrown out Medtronic subsidiary Covidien‘s patent on electrosurgical shears in a spat between the company and Johnson & Johnson‘s Ethicon Endo-Surgery subsidiary, according to court documents released this week.

The patent relates to a bipolar electrosurgical shearing instrument used to seal and cut blood vessels or vascular tissue, designed to use “both mechanical clamping action and electrical energy to coagulate, cauterize and/or seal tissue,” according to court documents. Read more

1. Retractable Technologies plummets after appeals court tosses $352m win over Becton Dickinson

Shares in Retractable Technologies lost nearly half their value last week after a federal appeals court overturned its $352 million anti-trust win over Becton Dickinson.

A 3-judge panel of the U.S. Court of Appeals for the 5th Circuit ruled Dec. 2 that RTI’s claim that BD violated a section of the Sherman Antitrust Act was “infirm as a matter of law.” Read more

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Implantable medical systems maker Kyocera Medical said today it won FDA 510(k) clearance for its Initia total hip implant system.

The Japanese company’s Initia total hip system includes Bioceram Azul zirconia-toughened alumina ceramic femoral heads, or can be requested with cobalt chrome femoral heads.

The system includes a total 16 tapered-wedge stem sizes, with 12 available in the US, according to a press release.

In late 2013, Amedica Corp. entered into an agreement with Kyocera to manufacture Amedica’s silicon nitride biomaterial at Kyocera’s Vancouver, Wash., facility.

The FDA-cleared silicon nitride has the potential to promote bone growth defend against infection. Devices made from silicon nitride are semi-radiolucent with clearly visible boundaries, enabling an exact view of intra-operative placement and postoperative fusion assessment via common imaging modalities, according to a press release.

The deal is expected to help Amedica meet demand for the technology, including spinal interbody devices. Amedica has sold over 14,000 of these devices worldwide, according to a company statement.

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Using the drug misoprostol in combination with a Foley balloon catheter to induce labor can lead to a speedier delivery, with women delivering several hours earlier than either method alone, according to research from the University of Pennsylvania. The team’s work was published in Obstetrics & Gynecology.

Nearly 1 million women who deliver in the U.S. each year undergo labor induction, but the process is still costly and doctors do not agree on 1 common practice.

The research team at UPenn touted its study as the largest-ever clinical trial of labor induction methods, enrolling 500 women who needed to undergo labor induction at the Hospital of the University of Pennsylvania. The participants were randomly split into 4 different treatment arms to induce labor: misoprostol alone, the Foley balloon catheter alone, the 2 methods combined, or the Foley balloon catheter with a synthetic version of oxytocin.

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

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Researchers from the Institute of Materials Science in Juazeiro, Brazil have reported on the antibacterial properties of usnic acid, a strong lichen metabolite, encapsulated in electrospun fibers. The team’s work was published in Recent Patents on Nanotechnology.

Usnic acid has been used in commercial products, such as creams, toothpastes and sunscreen, due to their antiviral, animicrobial and anti-inflammatory properties. To optimize the use of this compound as an alternative to antibiotics, the team of researchers sought to identify a way to encapsulate the compound and release it in a controlled manner at varying levels of acid concentration.

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

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Invendo Medical said today it won CE Mark approval in the European Union for its Invendoscope SC200, which it touts as the world’s 1st sterile, single-use colonoscope.

The German company said its device is designed to eliminate the complex reprocessing of endoscopes that create a serious risk of cross-contamination and the culturing of resistant bacteria.

“Our revolutionary technology uniquely addresses the significant challenges associated with the cleaning and disinfecting of traditional reusable endoscopes by providing an ergonomically advanced endoscope that offers both sterility and single use. The CE Mark is a significant accomplishment for our company, which enables us to provide endoscopists in Europe with a more advanced technology to perform colonoscopies and a system that enhances patient safety over current devices,” CEO Timo Hercegfi said in a press release.

The company said its Invendoscope SC200 won FDA 510(k) clearance earlier this year, and expects a market introduction of the scope in 2017.

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Artificial intelligence healthcare startup MedyMatch Technology said late last month its AI platform designed to detect intracranial hemorrhage or brain bleeds is now available for research.

The development is a milestone for the company, but is only the 1st stop for the platform, CEO Gene Saragnese told MassDevice.com in an interview.

“What we’ve done at MedyMatch is develop not just an algorithm, but an AI platform which looks at the entire patient – that is to say, the full richness of 3D imaging plus other patient attributes – to allow us, firstly, to understand whether that person is hemorrhagic stroke,” Saragnese said. “Our 1st application is in the area of bleed detection. Then it is our intent to leverage this platform to attack the next level up in terms of challenges within stroke, which is things like occlusion assessment, trying to understand if it is not a hemorrhagic stroke and what and how should I treat this patient for an ischemic stroke.”

The company focused on stroke 1st because of the massive risk it poses to the U.S. and the world as a whole, Saragnese said. By 2030, it is estimated that stroke will cost the US healthcare system $240 billion, and will affect 3.4 million people, he added.

The platform is designed to help physicians make more informed decisions in stroke, which is important due to the challenges inherent in diagnosing stroke.

“Stroke itself is sort of a distributed problem. People come into hospitals with headaches, bit of blurred vision, and the challenge is to determine whether they have had or are having a stroke,” Saragnese said.

The platform MedyMatch is developing is slated to come into fruition in several forms: a patient specific computer assisted detection device, as well as a prioritization algorithm within a PACS or CT machine to help prioritize cases based on the potential for a bleed. The platform could also see use as a proactive tool, to provide insights into populations.

“We believe these types of tools will be used to guide treatment as well. I’m a firm believer that this technology can have a huge impact in healthcare. By making better decisions in front of patient we can have a big impact on quality, which will impact outcomes, which will ultimately impact patients lives as well as healthcare costs,” Saragnese said.

But the platform won’t stop at Stroke, Saragnese added, and with future development, could help improve healthcare worldwide.

“Looking at the platform thats been developed, the 1st application is very exciting. But what that platform sets us up to do is to really continue to attack complex political problems that lie within the imaging space,” Saragnese said. “In the United States there’s roughly 1 physician for every 2 to 300 people. In other parts of the world its far, far more challenging. I see these types of applications, in particular the full 3D interpretation of the patient, helping in areas like the US where we’re trying to deliver higher quality care ad reduce waste in healthcare. But I also see it in places where there aren’t enough physicians to go around, where we can bring a higher quality of care, a higher degree of confidence in physicians.”

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The Center for Devices and Radiological Health (CDRH) recently issued its fiscal 2017 regulatory science priorities.  The list repeats some of the points highlighted in its 2016 list, while surfacing some new issues for consideration.

The CDRH started public disclosing it regulatory science priority list in FY 2015 and provides insight on how the agency will be directing its resources on regulatory science efforts.

Here is a listing of the CRRH’s regulatory science priorities in FY 2017.

1. Leverage “big data” for regulatory decision-making.
2. Modernize biocompatibility and biological risk evaluation of device materials.
3. Leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory decision-making.
4. Advance tests and methods for predicting and monitoring medical device clinical performance.
5. Develop methods and tools to improve and streamline clinical trial design.
6. Develop computational modeling technologies to support regulatory decision-making.
7. Enhance the performance of digital health and strengthen medical device cybersecurity.
8. Reduce health-care-associated infections by better understanding the effectiveness of antimicrobials, sterilization and reprocessing of medical devices.
9. Collect and use patient input in regulatory decision-making.
10. Leverage precision medicine and biomarkers for predicting medical device performance, disease diagnosis and progression.

What is your reaction to the CDRH’s 2017 regulatory science priorities?  Is this an improvement over the 2016 regulatory science priority listing?  Share your thoughts below.

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Neovasc (NSDQ:NVCN) said today that early clinical data on its Tiara transcatheter mitral valve replacement showed an 86% technical success rate and 100% freedom from mild, trace or absent paravalvular leakage.

The Vancouver-based company, which last month won approvals for a 115-patient CE Mark trial of the Tiara valve in Italy, said 22 patients have been implanted with the valve in the U.S., Canada and Europe. Results from those cases were presented in Tel Aviv this week at the annual ICI Meeting by Neovasc medical director Dr. Schmuel Banai.

All-cause mortality in the 19 patients who made the 30-day mark ws 15.7%. The longest follow-up period is nearing 3 years and the valve in that patient is fully functional. The 3 patient implanted within the last 30 days are “recovering well,” the company said, noting that there was a 0% rate of 30-day mortality for the last 8 patients treated more than 30 days ago. There were no adverse events related to the valve performance, no frame fractures and no device performance issues, Neovasc said.

“Tiara’s unique shape and trigonal tab anchoring system enables the device to be securely implanted with reduced risk of projecting into the [left ventricular outflow tract] or potentially interfering with prosthetic aortic valves which are commonly present in this patient population,” CEO Alexei Marko said in prepared remarks. “Furthermore, the Tiara anchoring system does not rely significantly on the integrity of the native mitral leaflets and therefore can be suitable for certain degenerative MR patients with flail leaflets or calcification. It has also been successfully shown that the design of Tiara makes it suitable for certain cases where mitral rings have been previously implanted in patients.”

Earlier this month, Neovasc agreed to a $75 million deal with Boston Scientific (NYSE:BSX) for its biotissue business that also included a 15% equity stake. The company is embroiled in a trade secret and patent battle with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve; late in October a federal judge in Massachusetts added $21 million to the $70 million Neovasc owes to CardiAQ in their spat over TMVR technology. The jury in May found that Neovasc misappropriated trade secrets in developing the Tiara TMVR. Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014.

Last month Neovasc dodged an investor lawsuit brought after its share price plunged in the wake of the court rulings.

NVCN shares, which closed up 65.1% yesterday at $1.42 apiece, gained another 9.9% this morning in pre-market trading to $1.56 each.

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Sanofi (NYSE:SNY) is reportedly considering a bid for Actelion Pharmaceuticals (VTX:ATLN), competing with an offer made to the Swiss biotech by Johnson & Johnson (NYSE:JNJ). Bloomberg reported that Sanofi is working with advisers to assess its options and has made its interest known informally to Actelion. The French drugmaker has not made a formal comment on the matter and has not decided if it will move forward with a bid.

J&J has been in talks with Actelion about what reports have said may be a $27 billion takeover bid. The high premium offer is tempting to shareholders, who would rather take the cash now than bet on Actelion CEO Jean-Paul Clozel’s risky pipeline for therapeutics targeting rare diseases.

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

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Medtronic (NYSE:MDT) said today that it won an expanded CE Mark indication in the European Union for its Endurant II/IIs stent graft for treating abdominal aortic aneurysms.

The expanded indication covers a new endovascular implantation approach using a parallel graft chimney approach called ChEVAR, which allows the device to be used to treat aneurysms with an aortic neck length of 2mm or more. Aortic neck length is the distance from the renal arteries to the aneurysm.

The ChEVAR approach, which uses balloon-expandable covered stents in the renal arteries and a stent graft in the aorta, is designed to increase the infrarenal “landing zone” for the stent graft. The Endurant II/IIs device was previously CE Marked for aortic neck lengths of 10mm or more, Fridley, Minn.-based Medtronic said.

The new indication was based on data from the Protagoras study using a standardized procedure in 128 patients that showed a 100% technical success rate, statistically significant aneurysm sac regression, 95.7% primary patency of the chimney grafts and a low incidence of chimney-related re-interventions, the company said.

“Medtronic is committed to partnering with our clinical community to provide solutions for challenging patients with complex aortic disease,” aortic business GM Daveen Chopra said in prepared remarks. “The expanded indication for our Endurant II/IIs stent graft system is a great example of how we can deliver solutions to address unmet clinical needs and improve standard of care for patients who have aneurysms with short neck lengths. We are excited to expand our leadership in EVAR with the first aortic stent graft approved for use with the ChEVAR technique.”

“Treating aneurysm patients with short aortic necks has been a long-time challenge for clinicians performing endovascular aneurysm repair (EVAR) to treat AAA patients,” added study co-author Dr. Giovanni Torsello of the St. Franzkisus Hospital in Mϋnster, Germany. “The availability of a standardized approach which increases anatomical applicability will help establish a new standard for patients with complex forms of AAA that may not have been suited for previous procedures.”

Endurant 1st won CE Mark approval in 2008. Medtronic said it plans to roll out the ChEVAR procedure in Europe and follow in other jurisdictions that recognize the mark. Endurant was approved in the U.S. in December 2010 for the 10mm aortic neck length indication but not for the ChEVAR approach.

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