The FDA approved a new Medtronic (NYSE:MDT) stent for peripheral arterial disease and green-lighted a pivotal clinical trial of a so-called “artificial pancreas” for Type I diabetics.
The pair of regulatory wins follow a decision that didn’t go Medtronic’s way, after an FDA panel last week recommended against approval of one of its cardiac ablation devices for a type of atrial fibrillation.
The Minneapolis-area medical device giant said its Assurant cobalt-chromium iliac stent found favor at the watchdog agency. Medtronic touts the device as the first balloon-expandable CrCo stent approved for narrowed iliac arteries in the U.S.
But it’s the Aspire trial that’s likely to grab the most attention. The FDA granted Medtronic an investigational device exemption for the second phase of the Automation to Simulate Pancreatic Insulin Response trial, which will involve in-home study of its subjects (the trial’s first leg involved in-patient treatment).
It’s designed to test the low glucose suspend feature in Medtronic’s MiniMed Paradigm insulin pump and its Enlite continuous glucose sensor.
Last week, an FDA advisory panel voted 8-2 not to recommend approval for Medtronic’s catheter-based radiofrequency device to treat a type of atrial fibrillation. The company acquired that technology when it bought Ablation Frontiers in 2009.
That sent MDT shares down nearly 3 percent as of about 11:10 today, to $34.48, after they opened down 1.5 percent on the news.