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.
Get this in your inbox everyday by subscribing to our newsletters.
5. Medtronic owes spine doc inventor $24m for patent infringement
Medtronic must fork over nearly $24 million to the physician inventor behind a group of patents covering a technique for treating spine defects.
Dr. Mark Barry sued Medtronic in February 2014 in the U.S. District Court for Eastern Texas, alleging infringement for 3 patents covering a “system and method for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions.” Read more
4. FDA panel recommends approval TransMedics lung transplant device
An FDA advisory panel yesterday recommended that the federal safety watchdog approve a device made by TransMedics to keep donated lungs perfused during transport to transplantation procedures.
The FDA’s Gastroenterology & Urology Devices panel voted 11-2 that the OCS Lung system is safe; 8-5 that it’s effective; and 9-4 that its benefits outweigh the risks, an FDA spokeswoman told MassDevice.com via email. Read more
3. EuroPCR Roundup: Medtronic’s Resolute Onyx meets primary endpoint in small-vessel trial
Medtronic‘s Resolute Onyx 2.0mm drug-eluting stent met its primary endpoint of target lesion failure at 1 year for the treatment of coronary artery disease in extra-small vessels, according to data from the Resolute Onyx 2.0mm trial.
The trial enrolled 101 patients with extra-small vessel sizes ranging from 2 millimeters to 2.25 millimeters. Patients treated with the Resolute Onyx 2.0 mm stent had significantly lower rates of target lesion failure at 1 year compared to a pre-determined performance goal. Read more
2. Endologix dives on 2-year setback for Nellix stent graft
Endologix shares were off more than 30% this morning after the company yesterday revealed a 2-year setback for its Nellix stent graft for repairing abdominal aortic aneurysms.
Irvine, Calif.-based Endologix said meetings with the FDA and “further internal analysis” led it to decide to launch a “confirmatory” trial for Nellix, which was initially delayed last November when the federal safety watchdog asked for 2-year follow-up data from the EVAS-Forward investigational device exemption study. Read more
1. FDA deals setback to Globus Medical’s ExcelsiusGPS robot-assisted surgery platform
Globus Medical said yesterday that the FDA won’t accept the 510(k) clearance bid for its ExcelsiusGPS robot-assisted surgery platform, likely delaying its launch until the 3rd quarter.
Globus said in a regulatory filing that the federal safety watchdog told it that the company hadn’t “sufficiently addressed the FDA’s questions” about its original clearance application. Audubon, Pa.-based Globus said it plans to file a revised application “in an expedited fashion.” Read more
