Devices & Diagnostics

FDA approves Medtronic stent to treat heart disease in diabetics

Medtronic (NYSE:MDT) announced Friday that the U.S. Food and Drug Administration has approved its Resolute […]


Medtronic (NYSE:MDT) announced Friday that the U.S. Food and Drug Administration has approved its Resolute Integrity drug-eluting stent, which is the first stent the agency has approved to treat coronary artery diseases in diabetics.

Medtronic believes diabetics suffering from coronary artery disease represent 30 percent of the nearly 1 million percutaneous coronary intervention procedures performed yearly in the U.S. Such procedures are inherently more difficult in patients with diabetes because their coronary arteries are narrower than those not afflicted by the condition.

“The Resolute Integrity DES offers several notable benefits, starting with outstanding deliverability, which means it’s exceptionally easy to navigate the stent on the delivery system through the coronary vasculature to the narrowed arterial segment that requires treatment,” explained Dr. Martin Leon, director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center. “Its approval by the FDA is based on the impressive performance of the Resolute DES in a wide variety of patients. With the device’s compelling combination of deliverability, efficacy and safety, not to mention that it is the first DES approved for patients with diabetes, the Resolute Integrity DES promises to gain rapid acceptance in cath labs nationwide.”

Leon, who is also founder and chairman emeritus of the Cardiovascular Research Foundation, was a principal investigator (PI) of Resolute’s clinical study in the U.S.

The Resolute Integrity stent is part of Medtronic’s cardiovascular business, which grew 8 percent last quarter to $830 million. In a quarterly earnings call with analysts on Nov. 22, chief financial officer Gary Ellis said that he expected the U.S. approval of Resolute Integrity would be a “meaningful driver of revenue growth and share gains.”

Ellis also spelled out the opportunity that Resolute represents domestically:

To put the U.S. opportunity in perspective, in Europe, where Resolute is approved and we have more competitors than in the U.S., our DES share is nearly double our U.S. share. In markets where we have regulatory approval for both our Resolute Integrity drug-eluting stent and the Integrity bare-metal stents, Medtronic holds the market-leading coronary stent share position. And we expect to drive growth by taking share when these products become available in new markets.

 

 

 

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