Peripheral/Endo

The VasQ™ External Support Now FDA Cleared for Use in Creating Arteriovenous Fistulas

TEL AVIV, Israel, Sept. 27, 2023 /PRNewswire/ — Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the FDA as a Breakthrough Technology, was cleared based on […]

FDA Approves LimFlow System in Patients With Chronic Limb-Threatening Ischemia and No Suitable Endovascular or Surgical Revascularization Options

PARIS & SAN JOSE, Calif.–(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 the LimFlow System to help people with […]

Humacyte Announces Positive Top Line Results from Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) in Treatment of Patients with Vascular Trauma

DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) —  Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. The single-arm clinical […]

Shape Memory Medical Receives FDA IDE Approval to Initiate AAA-SHAPE, a Head-to-Head Trial

SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced that the Food and Drug Administration (FDA) granted investigational device exemption (IDE) for the company to begin a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device […]

VentureMed Group Receives European Medical Device Regulation (MDR) Certification for FLEX Vessel PrepTM System

Minneapolis, Minnesota, September 6, 2023 – VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced today that the company is an early recipient of MDR certification. Gaining MDR certification […]

Zylox-Tonbridge’s ZENFlow Tiger™ LD PTA Dilatation Catheter Receives ANVISA Marketing Approval

HANGZHOU, China, Aug. 30, 2023 /PRNewswire/ — Zylox-Tonbridge Medical Technology Co., Ltd. (2190.HK, hereinafter referred to as “Zylox-Tonbridge” or the “Company”) announced that its ZENFlow Tiger™ LD PTA Dilatation Catheter (hereinafter referred to as “ZENFlow Tiger™”), a product independently developed by the Company, has received marketing approval from ANVISA. The Company expects […]

Haemonetics Announces European Expansion for VASCADE® Vascular Closure System

BOSTON, Aug. 29, 2023 /PRNewswire/ — Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, has announced that for the first time, patients have been treated with the company`s VASCADE MVP® Venous Vascular Closure system in Germany. This marks the first use of the […]

VESTECK Scientific Advisory Board members address significant global unmet need

WEST CHESTER, Pa., Aug. 28, 2023 /PRNewswire/ — In response to a significant global unmet need for the “SUTURE-TIGHT”™ catheter, VESTECK, Inc. is expanding the International Scientific Advisory Board. ​ VESTECK Scientific Advisory Board members address significant global unmet need We are honored to have Professor Dainis Krievins, from Latvia, Canadian, Dr. Bao Bui and Australian, Professor […]

Nectero Medical Receives FDA Fast Track Designation for Nectero EAST® System

TEMPE, Ariz.–(BUSINESS WIRE)–Nectero Medical, a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System to treat patients with infrarenal AAAs, maximum diameter 3.5 – […]

Instylla Announces Completion of $30MM EQUITY Financing

BEDFORD, Mass., Aug. 15, 2023 /PRNewswire/ — Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced the closing of a $30 million financing round. This financing round was led by new investor, Delos Capital, with continued participation from the investor syndicate of Excelestar Ventures, Ascension Ventures, Catalyst Health […]