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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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
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
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
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
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