LimFlow Receives FDA Approval for U.S. Pivotal Study of Minimally-Invasive Technology Designed to Prevent Amputations in Chronic Limb-Threatening Ischemia Patients

PARIS–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption for the PROMISE II pivotal study of the LimFlow Percutaneous Deep […]

Orchestra BioMed™ Announces FDA Breakthrough Device Designation for Virtue® Sirolimus-Eluting Balloon for Treatment of Below-the-Knee Peripheral Artery Disease

First and only non-coated sirolimus-eluting angioplasty balloon system to receive Breakthrough Device designation for below-the-knee disease Follows Breakthrough Device designation for Virtue Sirolimus-Eluting Balloon in coronary in-stent restenosis granted in Q2 2019 NEW HOPE, Pa., Sept. 17, 2019 (GLOBE NEWSWIRE) — Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a  biomedical innovation […]

Intact Vascular to Announce One-Year Data from TOBA III Clinical Trial

Study Investigates Use of the Tack Endovascular System® for Focal Dissection Repair Following Drug-Coated Balloon Angioplasty in PAD Patients WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that the one-year data from its Tack Optimized Balloon Angioplasty (TOBA) III clinical trial will be presented during […]

Rex Medical Receives 510k Clearance for Revolution™ Peripheral Atherectomy System

CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–Rex Medical, L.P., a medical device design and development company, today announced that it has received 510k Clearance from the U.S. Food and Drug Administration (FDA) for the Revolution™ Peripheral Atherectomy System. Regulatory clearance was based on data provided by the REVEAL IDE clinical trial. The results of […]

Corvia Medical and physIQ Partner in Global Phase 3 Heart Failure Clinical Trial to Leverage Novel Digital Endpoints

BOSTON–(BUSINESS WIRE)–Corvia Medical has sponsored and is actively enrolling patients in an innovative heart failure (HF) device trial that, in addition to measuring traditional heart failure endpoints, includes collecting and analyzing biosensor data with physIQ’s continuous remote monitoring platform. The clinical trial is designed to evaluate the clinical efficacy of […]

First Patient Enrolled in Cook Regentec’s Clinical Trial of Investigational Therapy for Critical Limb Ischemia

INDIANAPOLIS–(BUSINESS WIRE)–Cook Regentec today announced enrollment of the first patient in an international clinical trial evaluating the HemaTrate® Blood Filtration System to treat patients with critical limb ischemia (CLI) due to peripheral arterial disease (PAD). To treat CLI, the HemaTrate system produces an autologous, peripheral blood-derived total nucleated cell (TNC) concentrate […]

IN.PACT AV Access Trial Meets Primary Safety and Effectiveness Endpoints

IN.PACT AV Drug-Coated Balloon Shows Promise in Treating Arteriovenous Fistulae Lesions in End-Stage Renal Disease Patients DUBLIN and BARCELONA, Spain, Sept. 07, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) announced the first-ever results from the IN.PACT AV Access clinical study comparing the investigational IN.PACT™ AV™ drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) in patients with […]

Vascular Therapies Announces Positive Preliminary Clinical Results from its AV Fistula Trials in Patients with Kidney Disease

CRESSKILL, N.J., Sept. 9, 2019 /PRNewswire/ — Vascular Therapies, a clinical stage biotechnology company, is developing Sirogen™, a proprietary sirolimus formulation for intraoperative local, perivascular drug delivery focused on improving vascular access outcomes in patients with kidney disease.  Daniel G. Clair, MD, vascular surgeon and Chairman of the Department of Surgery at Palmetto Health-USC […]

Beacon® Tip Catheters Available in Europe Again

LIMERICK, Ireland–(BUSINESS WIRE)–Cook Medical is pleased to announce that Beacon® Tip Catheters are once again available to physicians in Europe. As of September 2019, the catheters are available in the UK, Ireland, Norway, Sweden, Finland, Denmark, Germany, Poland, the Netherlands, Luxembourg, Belgium, France, Switzerland, Austria, Hungary, Spain and Italy. Cook is […]

Concept Medical Inc. Granted ‘Breakthrough Device Designation’ From the FDA for Its MagicTouch AVF Sirolimus Coated Balloon

TAMPA, Fla.–(BUSINESS WIRE)–Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in hemodialysis treatment of renal failure. ​​​​​​The FDA received Concept […]