Medtronic Scores New Cardio Device Approvals

The medical device giant recently won U.S. FDA approval of what it touts as the first drug-coated balloon treatment for in-stent restenosis, and Medtronic's Reveal LINQ insertable cardiac monitor ICM system has won approval from Japanese regulators.

Chris Newmarker

Medtronic this week announced new cardio device regulatory approvals in the U.S. and Japan. 

In the U.S., FDA has approved IN.PACT Admiral drug-coated balloon for the treatment of in-stent restenosis in peripheral artery disease patients. Medronic says the approval marks the first time a drug-coated balloon has been approved in the U.S. for such a use. 

"We are experiencing a paradigm shift in treating patients with complex [peripheral artery disease]," said John Laird, MD, interventional cardiologist at U.C. Davis Medical Center and co-principal investigator for the IN.PACT SFA trial of the balloon. "Until now physicians have had limited treatment options to address patients with [in-stent restenosis]. The FDA's approval of IN.PACT Admiral DCB allows us to treat patients with a durable, proven, and safe technology."

In-stent restenosis, which takes place when plaque forms around an implanted stent, takes place in up to two-fifths of all stents placed in the superficial femoral artery, according to Medtronic. 

Also this week, Medtronic announced that Japanese regulators have approved Medtronic's Reveal Linq insertable cardiac monitor ICM system. About the size of a AAA battery, the Linq is placed in a 1 cm incision on the left side of the chest and helps physicians quickly and accurately diagnose irregular heartbeats. Medtronic launched Linq in 2014 after it won FDA clearance and CE Mark. The Linq has already proved itself to be a cardio device sales booster for Medtronic.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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