Peripheral/Endo

Medtronic Venous Stent Receives U.S. FDA Approval to Treat Venous Outflow Obstruction

Abre™ Venous Self-Expanding Stent System Safe, Effective in Treating Challenging Deep Venous Lesions DUBLIN, Oct. 26, 2020 /PRNewswire(opens new window)/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval for the Abre™ venous self-expanding stent system. This device is indicated for […]

Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO® (rivaroxaban) in Patients with Peripheral Artery Disease

Application seeks approval of XARELTO® plus aspirin to reduce the risk of major thrombotic vascular events in patients after lower-extremity revascularization due to symptomatic peripheral artery disease (PAD) XARELTO® is currently approved to reduce the risk of major cardiovascular events, like heart attack and stroke, in people with chronic PAD […]

FLEX Vessel Prep™ System Receives New Indication to Address In-Stent Restenosis

MINNEAPOLIS, Oct. 21, 2020 /PRNewswire/ — VentureMed Group, Inc. (VentureMed), a privately-held medical device innovator in vessel preparation for interventional treatment of peripheral arterial disease (PAD) and stenoses of arteriovenous (AV) fistulas and grafts, announced today that the U.S. Food and Drug Administration (FDA) cleared the Company’s FLEX Vessel Prep™ System for use in […]

Aidoc granted AI industry-first FDA clearance for triage of incidental pulmonary embolism

This is the company’s 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market NEW YORK, Oct. 21, 2020 /PRNewswire/ — Aidoc announced today that the US Food and Drug Administration (FDA) has given regulatory clearance for the commercial use of its triaging and notification algorithms […]

Inari Medical Announces Presentation of Positive Results from First Patients in Real World FLASH Registry

IRVINE, Calif., Oct. 19, 2020 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases, today announced positive results of the first 230 patients enrolled in its FLASH study. Interim […]

Nine-Month Results from Medtronic IN.PACT BTK Study Presented in Late-Breaking Clinical Trial Sessions at TCT Connect Annual Meeting

Feasibility Study of Medtronic Drug-Coated Balloon Technology for Challenging Below-the-Knee Disease Shows Promise in Patients with Critical Limb Ischemia DUBLIN, Oct. 18, 2020 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced the first-ever results from the IN.PACT BTK Study, a feasibility study assessing the safety and effectiveness […]

Avinger Announces First US Cases with TIGEREYE(TM) Image-Guided CTO Crossing Catheter

REDWOOD CITY, CA / ACCESSWIRE / October 19, 2020 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that physicians in three U.S. sites have successfully treated patients with the TIGEREYE™ next […]

Ra Medical Systems Announces 10 Subjects Have Been Enrolled in its DABRA Pivotal Atherectomy Clinical Trial

CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces enrollment of the 10th subject in its pivotal clinical trial to evaluate the safety and effectiveness of the DABRA excimer laser system as an atherectomy device […]

GNT Pharma Announces Positive Top-Line Results in a Phase II Study of Nelonemdaz for Acute Ischemic Stroke Patients Treated With Endovascular Thrombectomy

Safety and Tolerability Established Good and Excellent Functional Outcome Increased YONGIN, South Korea–(BUSINESS WIRE)–GNT Pharma Inc. today reports positive top-line results from a phase II, double-blind, randomized, placebo-controlled, multi-center study assessing the safety and efficacy of nelonemdaz in acute ischemic stroke patients treated with endovascular thrombectomy within 8 hours of symptom […]

Endologix Launches ALTO™ Abdominal Stent Graft System in Europe

First European Commercial Case Completed at East & North Hertfordshire Hospital in England IRVINE, Calif.–(BUSINESS WIRE)—Oct 15, 2020–Furthering its mission to transform the treatment of aortic disorders, Endologix LLC today announced the first implant of its ALTO™ Abdominal Stent Graft, commencing the European commercial release of the recently CE Mark […]