Medtronic has received FDA clearance to market the Integrity Coronary Stent System, a bare metal device, in the U.S. The stent received European approval back in February and the Resolute Integrity, the drug eluting version, was made available in CE mark accepting countries just last month.
Medtronic set the standard for deliverability with the modular design of the Driver bare-metal and Endeavor drug-eluting stents. These devices 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. Conformability is a measure of the stent’s ability to conform to the natural shape of the vessel. For these and other reasons, continuous sinusoid technology represents Medtronic’s platform of the future for coronary stents.
Press release: Medtronic Receives FDA Approval of Integrity® Coronary Stent…
Product page: Integrity…
Flashback: Medtronic’s Resolute Integrity Now Available in Europe
