New Bare Metal Coronary Stent Cleared by FDA


September 20, 2010

September 20, 2010 – The U.S. Food and Drug Administration (FDA) has approved the Integrity coronary stent system, which is said to offer better delivery.

Instead of rings, continuous sinusoid technology enables each cobalt alloy 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 radial strength. The Integrity stent is also highly conformable to the natural shape of the vessel. To maximize flexibility, the crowns are laser-fused where only certain points on the crowns meet.

The Integrity has been shown in bench-testing and in blinded in vivo physician assessment studies to be highly deliverable.

Mark Turco, M.D., 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 stent in clinical practice.

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

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.

The company said continuous sinusoid technology may allow for a drug-filled stent, which could obviate the need for a polymer. Regulation of drug elution could be achieved by using holes on the surface of a hollow tube.

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