What To Know
- While the product is not commercially available yet, 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.
- 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.
Cook Medical has received Breakthrough Device designation from the US Food and Drug Administration (FDA) on a new drug-eluting stent for below the knee (BTK). This new stent is designed to treat patients suffering from 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,”said Mark Breedlove, vice president of Cook Medical’s Vascular division. “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. While the product is not commercially available yet, 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.
To learn more about the FDA’s Breakthrough Devices program, click here. To learn more about Cook Medical’s limb preservation program, click here.
