Medtronic Receives FDA Approval of Integrity® Coronary Stent

Instead of rings, continuous sinusoid technology enables each stent to be made from a single wire, comparable to a flexible spring.


MINNEAPOLIS – Sept. 20, 2010 – Medtronic, Inc. announced the U.S. Food and Drug Administration (FDA) approval of the Integrity Coronary Stent System. The new platform for Medtronic’s coronary stents, including the Integrity bare-metal stent, is based on an advance in biomedical engineering called continuous sinusoid technology that enables the exploration of other breakthrough device concepts such as a polymer-free drug-filled stent.

Now available in the United States, the Integrity Coronary Stent System has been shown in bench testing and in blinded in vivo physician assessment studies to be highly deliverable.

Dr. Mark Turco, director of cardiac and vascular research at Washington Adventist Hospital in Tacoma Park, Md., was among the first interventional cardiologists in the United States to use the Integrity Coronary Stent System in clinical practice.

“The Integrity stent system sets a new gold standard for deliverability thanks to the advance of continuous sinusoid technology,” Dr. Turco said. “This new platform negotiates the twists and turns of the coronary anatomy remarkably well.”

The Driver bare-metal and Endeavor drug-eluting stents are made from rings of a cobalt alloy that are shaped into crowns and, to maximize flexibility, laser fused where only certain points on the crowns meet. The Integrity stent is also made from cobalt alloy and is laser fused in a similar pattern.

Instead of rings, continuous sinusoid technology enables each stent to be made from a single wire, comparable to a flexible spring. Coupled with the MicroTrac delivery system, this engineering advance offers exceptional deliverability without compromising other important stent design characteristics like radial strength. Like the Driver stent, the Integrity stent is also highly conformable.

The Integrity Coronary Stent System received the CE (Conformité Européene) mark in February and is currently available in approximately 100 countries outside the United States. In the ensuing six months, it enabled Medtronic to achieve the market-leading position for bare-metal stents in Western Europe and Central Asia.

More information is available at http://www.medtronic.com [1]