Peripheral/Endo

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 […]

MedAlliance announces the completion of enrollment in SAVE Trial with SELUTION SLR for Treatment of AV Fistulas in Renal Dialysis Patients

GENEVA, Aug. 15, 2023 /PRNewswire/ —  MedAlliance has announced completion of patient enrollment in the  SAVE Clinical Trial with the SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of failed AVF (arteriovenous fistulas) in renal dialysis patients. SELUTION SLR is a novel sirolimus-eluting balloon that provides a controlled sustained release of […]

MCRA Aids Surmodics in Obtaining FDA Pre-Market Approval for Cardiovascular Drug-Coated Balloon

WASHINGTON, Aug. 7, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH) is pleased to announce its role in the successful […]