BEAUFORT, S.C.–(BUSINESS WIRE)–According to THE SAGE GROUP, in 2015 almost 20 million Americans suffered from PAD representing an economic burden of $224-$414 billion. “Almost 20 years ago, we wrote that PAD was underestimated, underdiagnosed and undertreated,” stated Mary L. Yost, […]
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 […]
Cardiovascular Systems, Inc. Announces First Patient Enrolled in REACH PVI Clinical Study
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 the first patient was enrolled in the REACH PVI study. […]
Intact Vascular Announces US Launch of the Tack Endovascular System® and First Commercial Use
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the first commercial use of its Tack Endovascular System in multiple sites across the United States. Recently FDA-approved for above-the-knee interventions, the […]
Healogics® Brings Vein Ablation Services to Wound Care Centers®
JACKSONVILLE, Fla., March 21, 2019 /PRNewswire/ — Healogics, the nation’s largest provider of advanced chronic wound care services, today announced they have added vein ablation to their in-house service offerings through a new program called Healogics® VeinCare. This program allows Healogics to provide […]
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) […]
THE SAGE GROUP Announces Publication of U.S. Acute Limb Ischemia (ALI) Incidence and Market Estimates
BEAUFORT, S.C.–(BUSINESS WIRE)–A new analysis published by THE SAGE GROUP concludes that ALI represents a substantial market opportunity for pharmaceutical and interventional therapies. “Although the number of patients currently treated for an acute occlusion in the lower limbs is relatively […]
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 […]
Avinger Announces 510(k) Filing of Pantheris Small Vessel Device
REDWOOD CITY, Calif., Aug. 30, 2018 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the Company submitted a new 510(k) application to the U.S Food & Drug Administration (FDA) […]