Tag: PAD

Concept Medical Inc. Granted 2nd ‘Breakthrough Device Designation’ From the FDA for Its MagicTouch PTA Sirolimus Coated Balloon, for the Treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK) Indication

Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA (Percutaneous Transluminal Angioplasty), its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee […]

Rex Medical Completes Patient Enrollment for the REVEAL Peripheral Atherectomy U.S. Trial

March 19, 2019 10:14 AM Eastern Daylight Time CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–Rex Medical, L.P., a medical device design and development company, today announced the successful completion of enrollment in the Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization (REVEAL) […]

First Patients in Europe Treated with Cardiovascular Systems, Inc. Peripheral Orbital Atherectomy System

ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patients in Germany have been treated with […]

Eximo Medical Receives FDA Clearance for B-Laser™ Atherectomy System to Treat Peripheral Artery Disease (Including ISR)

REHOVOT, Israel–(BUSINESS WIRE)–Eximo Medical Ltd. announced today it has received 510(k) clearance from the U. S. Food & Drug Administration (FDA) for its B-Laser™ Atherectomy System for Peripheral Artery Disease (PAD). B-Laser™ is a transformative 355nm wavelength laser technology designed to address unmet clinical needs for treating multiple […]