Cook Medical’s New BTK DES to Treat CLTI Receives FDA Breakthrough Designation

January 21, 2022—Cook Medical announced it has received Breakthrough Device designation from the FDA on a new drug-eluting stent (DES) for below-the-knee (BTK) application. The device is designed to treat patients with chronic limb-threatening ischemia (CLTI).

Mark Breedlove, Vice President of Cook Medical’s vascular division, commented in the company’s press release, “CLTI is a debilitating disease of growing prevalence around the globe, and this is Cook Medical’s latest innovation within our peripheral artery disease program.”

Mr. Breedlove continued, “This new product leverages our deep understanding of stent design and drug elution for lower limb anatomies, and it complements our dedicated portfolio of BTK products for limb preservation. Our goal is to improve the long-term clinical outcomes for CLTI patients.”

The Breakthrough Device designation is granted for devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

Although the product is not commercially available, the benefits of the designation include priority review and interactive and timely communication with FDA during the clinical trial and premarket review phases in order to help get lifesaving devices to patients more quickly, advised the company.