Peripheral/Endo

Novel Bioengineered Vessel Outperforms Arteriovenous Fistula in High-Risk Patients on Hemodialysis

NEW ORLEANS, LA, JUNE 6, 2025 – Findings from a phase three, randomized controlled clinical trial demonstrate the superiority of Humacyte’s Acellular Tissue Engineered Vessel (ATEV) over autologous arteriovenous fistula (AVF) in high-risk patients with end-stage kidney disease (ESKD). These data highlight the potential of ATEV to address unmet needs […]

Penumbra Introduces the Ruby® XL System – the Longest, Largest, and Softest Coil on the Market for Vascular Embolization

ALAMEDA, Calif., June 5, 2025 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN) announced the U.S. Food and Drug Administration (FDA) clearance and launch of the Ruby® XL System, the longest, largest and softest coil on the marketi. The Ruby XL System is designed to help physicians achieve more…

MolecuLight to Showcase Innovative Wound Imaging Platform at the Society for Vascular Surgery Vascular Annual Meeting (VAM) 2025

PITTSBURGH, June 4, 2025 /PRNewswire/ – MolecuLight Corp., a global pioneer in point-of-care fluorescence imaging for rapid detection of infection causing bacteria in wounds, is pleased to announce its participation in the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM),…

FDA Grants De Novo Clearance for Reflow Medical’s Spur® Peripheral Retrievable Stent System

San Clemente, CA – May 29, 2025 – Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for the company’s Spur Peripheral Retrievable Stent System a unique clinical solution for the treatment of […]

Phraxis Announces FDA Approval of EndoForce™ Connector for Endovascular Venous Anastomosis, Advancing Dialysis Access Innovation

MINNEAPOLIS, May 22, 2025 /PRNewswire/ — Phraxis Inc., a Minneapolis-based medical device company, marks a major milestone with FDA approval of the EndoForce™ Connector for Endovascular Venous Anastomosis (EndoForce™) — a pivotal development in the evolution of dialysis access technology….

Merit Medical Releases 12-Month Efficacy Results for the Single-Arm Arteriovenous Graft (AVG) Cohort of the WRAPSODY® Arteriovenous Efficacy (WAVE) Trial

In the AVG cohort of the US pivotal trial, the Merit WRAPSODY Cell-Impermeable Endoprosthesis (CIE) achieved 60.2% target lesion primary patency (TLPP) at 12 months. In the AVG cohort of the US pivotal trial, the Merit WRAPSODY Cell-Impermeable Endoprosthesis (CIE) achieved 60.2% target lesion primary patency (TLPP) at 12 months.

AROA hits evidence milestone with real-world study validating the efficacy of Endoform in treating challenging venous leg ulcers.

AUCKLAND, New Zealand, May 1, 2025 /PRNewswire/ — Soft tissue regeneration company, Aroa Biosurgery, is pleased to announce a milestone in clinical evidence. There are now over 100 peer-reviewed studies describing the efficacy of the company’s proprietary AROA ECM technology. AROA’s most…