Peripheral/Endo

Hyperflex® Balloon Catheter by Endovastec™ Receives Marketing Approval in Japan

SHANGHAI, March 28, 2022 /PRNewswire/ — Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec™) recently announced that it has received registration approval from Japan Pharmaceuticals and Medical Devices Agency (PMDA) for its independently-developed Hyperflex® Balloon Catheter (Hyperflex®) as the company’s first product approved for marketing in Japan. Hyperflex® obtained CE Mark in 2016 […]

First-in-Man Use of the Tractus™ Crossing Support Catheter with its Jigsaw Technology™ Shaft

EATONTOWN, N.J.–(BUSINESS WIRE)–Tractus Vascular, LLC today announced the first-in-man use of the TractusTM Crossing Support Catheter (TractusTM CSC). The TractusTM CSC represents a highly novel approach to treating vascular disease. Chronic total occlusion (CTO) remains one of the most challenging pathologies encountered by surgeons and interventionalists in performing endovascular interventions. Drs. John H. Rundback […]

Einstein Researchers Find New Strategy for Preventing Clogged Arteries

BRONX, N.Y., March 28, 2022 /PRNewswire/ — Revving up a process that slows down as we age may protect against atherosclerosis, a major cause of heart attacks and strokes. In findings publishing online this week in Proceedings of the National Academy of Sciences (PNAS), scientists at Albert Einstein College of Medicine led by Ana Maria Cuervo, M.D., Ph.D., successfully […]

Ra Medical Systems Achieves Milestone of 100 Subjects Enrolled in its Pivotal Atherectomy Clinical Study

CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED), a medical device company focusing on developing its excimer laser system to treat vascular diseases, announces the achievement of a milestone with the enrollment of 100 subjects in its pivotal clinical study to evaluate the safety and effectiveness of the DABRA […]

Sky Medical Technology wins further FDA clearance to market the new (W3) geko™ device variant for venous insufficiency and ischemia

DARESBURY, England, March 25, 2022 /PRNewswire/ –Sky Medical Technology Ltd (Sky) has today announced it has achieved further U.S. Food and Drug Administration (FDA) 510(k) clearance to market the new (W3) geko™ device variant, for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia. This latest […]

Artio Medical Receives FDA Clearance for Solus Gold™ Embolization Device

Company Prepares for US Commercial Launch PRAIRIE VILLAGE, Kan., March 22, 2022 /PRNewswire/ — Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and cardiology markets, today announced it received US Food and Drug Administration (FDA) clearance for its Solus Gold Embolization Device, a next-generation product for peripheral vascular […]

Instylla First-In-Human Clinical Trial Published Results Demonstrate Technical Success and Persistent Embolization Across All Patients

Prospective multicenter study evaluated the safety and efficacy of a PEG-based liquid embolic in treating hypervascular tumors BEDFORD, Mass., March 15, 2022 /PRNewswire/ — Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced the publication of resultsi from the first-in-human clinical trial of Embrace™ Hydrogel Embolic System (HES) […]

LimFlow Completes Enrollment in PROMISE II U.S. Pivotal Trial of Breakthrough Device Designed to Prevent Amputations in No-Option Patients With Chronic Limb-Threatening Ischemia

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 it has completed patient enrollment in the PROMISE II pivotal trial of the LimFlow System. The LimFlow System is designed […]

Fist Assist Devices, LLC Announces Australian Distribution Deal and Sales Launch

Regional Health Care Group Selected For Commercialization in Australian Market. LAS VEGAS–(BUSINESS WIRE)–Fist Assist Devices, LLC, announces a three-year affiliation with Regional Health Care Group to commercialize and launch sales of the Fist Assist Model FA-1 device in Australia and New Zealand. The Fist Assist Model FA-1 is a wearable, […]