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. Corvia Medical wins FDA nod for trial, inks exclusive buyout deal with strategic backer
Corvia Medical said that it won an investigational device exemption from the FDA for a clinical trial of its cardiac implant designed to treat diastolic heart failure and inked a deal with an unnamed strategic investor that includes an exclusive buyout option.
Corvia’s transcatheter InterAtrial shunt device is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria, according to Corvia’s website. Read more
2. Medtronic launches real-world trial for CoreValve Evolut R heart valve
Medtronic said that it’s launching a real-world trial of its CoreValve Evolut R transcatheter aortic valve implant in high- and extreme-risk patients.
The 1,000-patient Evolut R Forward trial is a single-arm, prospective study with a primary endpoint of all-cause mortality at 30 days, with secondary endpoints of Valve Academic Research Consortium-2 safety and efficacy. The study is designed for follow-up at implant, 30 days, 1 year, 2 years and 3 years, Fridley, Minn.-based Medtronic said. Read more
1. Palmaz Scientific, seeking buyer, files for bankruptcy protection
Palmaz Scientific said that it filed for Chapter 11 bankruptcy protection while it seeks a buyer for the medical alloy technology it was developing, claiming it’s ability to attract investors was “seriously impaired by a negative campaign of false information.”
Co-founded by coronary stent pioneer Dr. Julio Palmaz in 2008, the San Antonio, Texas-based company last summer told its shareholders that Palmaz planned to resign as chairman in favor of former Kinetic Concepts Inc. CEO Cathy Burzik. Serving as interim CEO, Burzik was to have help find a replacement for ex-chief Steven Solomon, and a cash infusion from a group of investors led by venture capital shop Targeted Technology, where Burzik is an operating partner. Palmaz was to have remained with his namesake as chief scientific officer. Read more
