FDA approves Medtronic's Integrity stent platform

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The FDA has approved Medtronic’s Integrity coronary stent system, a new platform that includes the Integrity bare-metal stent.

Based on biomedical engineering called continuous sinusoid technology, the Integrity allows the exploration of device concepts, such as the polymer-free drug-filled stent, according to the Minneapolis-based company. The Integrity stent is made from cobalt alloy and is laser fused in a pattern similar to the modular design of the Driver bare metal stent and Endeavor drug-eluting stent.

Instead of rings, continuous sinusoid technology allows each stent to be made from a single wire, Medtronic stated.

Immediately available in the U.S., Mark A. Turco, MD, director of cardiac and vascular research at Washington Adventist Hospital in Tacoma Park, Md., was the first interventional cardiologist in the U.S. to use Integrity in clinical practice.

Integrity received the CE mark in February and is currently available in approximately 100 countries outside the U.S.