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Medtronic allowed to sell next-gen stent in U.S.
A graphic showing the Resolute Integrity stent implanted in a coronary artery. After reaching the narrowing in the artery, the balloon inflates to expand the stent against the artery wall to keep the artery open and restore normal blood flow to the heart.
MedtronicPublished: Friday, February 17, 2012 at 5:29 p.m.
Last Modified: Friday, February 17, 2012 at 5:29 p.m.
Medtronic's Santa Rosa division won federal approval Friday to begin selling its next-generation coronary stent in the United States, a decision that allows it to vie for a bigger share of the $1.5 billion U.S. market for drug-coated stents.
The Resolute Integrity stent has been available outside the United States since 2010.
“This is a very important launch for Medtronic,” said Joe McGrath, spokesman for the company's vascular division. “We expect Resolute will rival the market-leading platform.”
The device was developed in Santa Rosa, headquarters for Medtronic's vascular business.
Stents are tiny mesh tubes that doctors implant in patients' clogged arteries to keep blood flowing to the heart. Nearly 1 million are used in the U.S. each year.
Resolute Integrity uses new engineering that makes it easier for physicians to place in narrow, twisted arteries, Medtronic said. The stent also is coated with drugs that prevent arteries from re-clogging.
The device is designed for a wide variety of patients, and is the first approved for treating diabetics with coronary artery disease, the company said. Patients with diabetes are difficult to treat because they tend to have small arteries and other complicating conditions.
The new device “has gained wide global acceptance for its remarkable ability to successfully meet clinical and anatomic challenges that interventional cardiologists confront in their everyday practice,” said Sean Salmon, who heads Medtronic's coronary business.
The current U.S. market leader in the category is Abbott Laboratories' Xience V stent.
The domestic market for drug-coated stents is potentially lucrative for Medtronic. The Minneapolis-based company sold $192 million worth of drug-coated stents worldwide last quarter, but only $40 million in the United States.
Medtronic's vascular business posted $2.13 billion in sales last year, up from $1.98 billion in 2010. The company has about 840 employees in Santa Rosa.
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