AGA Medical has received federal approval to begin a clinical trial of a heart device that’s designed to prevent strokes in patients with abnormal heartbeats. The trial is intended to evaluate the safety and efficacy of the company’s Amplatzer cardiac plug in preventing blood clots in the heart that can lead to strokes. The trial […]
Someday, in the not-so-distant future, EnteroMedics Inc. officials might look back at late 2009 and laugh. Or cry. That ultimately depends on whether the Food and Drug Administration ultimately approves or rejects the company’s groundbreaking Maestro device. Approval means enormous financial success, the only implantable neurostimulation device in the United States designed to treat obesity. […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The company received Chinese regulatory approval and licenses for its AMPLATZER PFO Occluder and AMPLATZER Multi-Fenestrated Septal Occluder "Cribriform." It also received approval, with a license pending, for its AMPLATZER Vascular Plug II. Septal occluders represent about 60 percent of company sales, while the PFO Occluder has represented about 15 percent of company sales in recent years, according to regulatory filings.
The California ruling deals AGA's with Amplatzer Occluder and vascular plug product lines, which help treat some forms of heart disease. Along with the $57 million, the jury said AGA would pay Medtronic 11 percent on future sales until 2018.
The Australian Therapeutic Goods Administration has approved St. Jude Medical's Libra and LibraXP deep brain stimulation devices that treat symptoms of Parkinson's disease. The device, which operates like a pacemaker to stimulate sections of the brain, is already approved for use in Europe and is in clinical trials in the United States for treating depression and Parkinson’s, among other things.