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 (BTK). The first ‘Breakthrough Device Designation’ received by Concept Medical […]

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. The purpose of this study is to prospectively evaluate acute […]

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 first-of-its-kind dissection repair device is implanted post-angioplasty to resolve dissections […]

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 patients with a higher level of care in a more […]

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) IDE clinical trial. The REVEAL trial is a single arm, […]

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 small, the total market is surprisingly large,” stated Mary L. […]

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 its Stealth 360® Peripheral Orbital Atherectomy System (OAS). The German cases […]

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 vascular indications. The specific indication cleared by the FDA is: […]

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) for the Pantheris SV (Small Vessel) Lumivascular atherectomy system. Pantheris […]

Cardiovascular Systems Presents Liberty 360° Two-Year Outcomes at 2018 Amputation Prevention Symposium

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, presented two-year outcomes from its LIBERTY 360° study in a late-breaking presentation at the 2018 Amputation Prevention Symposium (AMP) in Chicago. The […]