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. Reva Medical extends Fantom stent trial to Europe
Reva Medical said that it’s expanding a trial of its Fantom bioabsorbable drug-eluting stent to Europe, a few months after launching the study in Brazil.
The 1st implantation in Europe for the Fantom II clinical trial took place in Denmark, the San Diego-based company said. Fantom is delivered through either the femoral artery in the groin or the radial artery in the wrist. Like traditional metal stents, it’s designed to expand and prop up an artery in order to clear it of blocked plaque. Unlike those stents, however, Fantom is designed to dissolve and disappear in the body over time. Read more
2. Senate health panel mulls medical device tax
A U.S. Senate subcommittee held a hearing on the medical device tax featuring testimony about its deleterious effects from industry and patient advocates.
The Senate Finance Committee’s healthcare panel, led by Sen. Patrick Toomey (R-Pa.) and ranking member Sen. Debbie Stabenow (D-Mich.), convened the hearing to consider the impact of the medical device tax. Read more
1. TAVI: Edwards CEO says Sapien 3 could hit U.S. market this year
Edwards Lifesciences CEO Michael Mussallem yesterday said the company believes the FDA could approve its next-generation Sapien 3 transcatheter aortic valve implant this year.
“Based on the strength of the Sapien 3 data presented at [the American College of Cardiology’s annual meeting], the very positive clinician feedback about the valve’s performance and the encouraging discussions with the FDA, we believe it’s becoming more likely that we will obtain U.S. approval of our latest-generation valve this year,” Mussallem said during a conference call discussing the Irvine, Calif.-based company’s 1st-quarter results. Read more