Cook Medical receives FDA breakthrough designation for new drug-eluting stent

Graphic representation of BTK intervention. Image courtesy of Cook Medical

Cook Medical has received Breakthrough Device designation from the Food and Drug Administration (FDA) on a new drug-eluting stent (DES) for below the knee (BTK). This new stent is designed to treat patients suffering from chronic limb-threatening ischemia (CLTI).

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, a Cook Medical press release details.


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