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Breakthrough Device designation granted for Efemoral scaffold system designed to treat CLTI
Efemoral Medical has announced the granting of Food and Drug Administration (FDA) Breakthrough Device status for its novel Efemoral vascular scaffold system (EVSS) designed to treat de novo or restenotic lesions of the infrapopliteal arteries in patients with chronic limb-threatening ischemia (CLTI).…
Cook Medical receives FDA breakthrough designation for new drug-eluting stent
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…
FDA grants Nexus aortic arch stent graft system breakthrough designation
Endospan was recently granted breakthrough device designation from the Food and Drug Administration (FDA) for the Nexus aortic arch stent graft system. The FDA’s breakthrough device designation program is intended to provide timely access to medical devices that have the…