Cordis Corporation announced the European CE marking and U.S. Food and Drug Administration (FDA) approval of additional sizes of its SLEEK® OTW platform, a 0.014 inch ultra-low profile percutaneous transluminal angioplasty (PTA) dilatation catheter. The Cordis SLEEK® OTW PTA Dilatation Catheter is a highly deliverable balloon catheter designed to treat patients undergoing peripheral angioplasty procedures below the knee. The SLEEK® OTW catheter was first launched around the world in 2011. Cordis will start commercializing these new sizes immediately in various countries around the world.
Lower limb amputation is a last resort for many patients with end-stage peripheral arterial disease (PAD). It is estimated that as many as 160,000 lower limbs are amputated every year in the U.S. and 60-70 percent of these amputations are performed as the first-line therapy. These lower-limb amputations come with a mortality rate of as much as 70 percent at five years.
The SLEEK® OTW catheter has a unique balance of excellent pushability with a small crossing profile that helps physicians restore blood flow to the lower limbs. As part of the product line extension, Cordis now offers additional lengths of 20mm and 280mm for most of its current diameters. The new 280mm length will enable physicians to treat diffuse disease with fewer inflations. The SLEEK® OTW catheter continues to be the only peripheral balloon offering an ultra low profile 1.25mm diameter option. The addition of these sizes now means that the Cordis SLEEK® OTW platform offers physicians the broadest 0.014 over-the-wire catheter portfolio on the market.
“The SLEEK® OTW catheter has enabled me to treat patients with severe chronic limb ischemia using the Angiosome Concept. Now, more than ever, with the new expanded sizes, we will be able to effectively treat extremely distal lower leg peripheral vascular disease using fewer inflations,” said William Wu, M.D. from the Heart and Vascular Clinic of San Antonio. “I look forward to continue working with Cordis as they bring more products to market that will help provide safe and optimal outcomes for patients.”
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