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. Edwards Lifesciences wins FDA nod for new Sapien 3 trial
Edwards Lifesciences said that the FDA approved a new trial of its Sapien 3 replacement heart valve.
The Sapien 3 transcatheter aortic valve replacement was approved last year by the federal safety watchdog for patients at high risk of death from open surgical procedures to replace their aortic valve. The new investigational device exemption for the Partner III trial is designed to evaluate the Sapien 3 TAVR in patients with a low mortality risk from open surgical valve replacement, the Irvine, Calif.-based company said. Read more
2. AngioDynamics must face Bard patent infringement lawsuit
AngioDynamics must face a patent infringement lawsuit brought by Bard and subsidiary Bard Peripheral Vascular, a federal judge in Delaware ruled.
Murray Hill, N.J.-based Bard sued AngioDynamics in March 2015, alleging that its Smart Port and other implantable power-injectable port products trespass on a trio of Bard patents, according to court documents. Read more
1. Boston Scientific smuggled counterfeit resin for pelvic mesh, racketeering lawsuit alleges
A purported class-action racketeering lawsuit filed accused Boston Scientific of illegally smuggling counterfeit resin made in China to make pelvic mesh, after its original supplier allegedly refused to continue providing the product because it’s not supposed to be implanted in humans.
The lawsuit was filed Jan. 12 in the U.S. District Court for Southern West Virginia, the venue for multi-district litigation against a clutch of companies over their respective mesh products for treating female urinary incontinence and pelvic organ prolapse. Read more
