Cook Medical recently announced that it received FDA breakthrough designation for its drug-eluting stent for below the knee.
Bloomington, Indiana-based Cook Medical designed the stent to treat patients who have chronic limb-threatening ischemia (CLTI).
“CLTI is a debilitating disease of growing prevalence around the globe and this is Cook Medical’s latest innovation within our peripheral artery disease (PAD) program,” Mark Breedlove, VP of Cook Medical’s vascular division, said in a news release. “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.”
Cook Medical’s drug-eluting stent is not commercially available yet, but the breakthrough designation gives the company priority review and interactive and timely communication with FDA during clinical trials and premarket review phases.