Medtronic Receives FDA Approval for Integrity Coronary Stent

September 20, 2010—Medtronic, Inc. (Minneapolis, MN) announced that the US Food and Drug Administration has approved the Integrity coronary stent system. The company noted that in bench testing and in blinded in vivo physician assessment studies, the Integrity bare-metal stent was shown to be highly deliverable. Now available in the United States, the Integrity received CE Mark approval in February and is available in approximately 100 countries outside the United States.

According to the company, the new platform for Medtronic's coronary stent systems, including the Integrity, is based on continuous sinusoid technology, which enables each stent to be made from a single wire. The Integrity, coupled with the company's MicroTrac delivery system, provides a high level of conformability and deliverability while maintaining radial strength.

“The Integrity stent system sets a new gold standard for deliverability thanks to the advance of continuous sinusoid technology,” commented Mark Turco, MD. “This new platform negotiates the twists and turns of the coronary anatomy remarkably well. Continuous sinusoid technology should prove to be an excellent platform for future product development.”