MINNEAPOLIS, July 30, 2024 /PRNewswire/ — 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 it has completed enrollment of The FLEX First AV Registry.
This “FLEX First” AV Registry was designed to treat subjects with AVF/AVG stenosis to demonstrate The FLEX Vessel Prep™ System combined with balloon angioplasty will improve the rate of target lesion primary patency as compared with comparable published rates of balloon angioplasty alone. This study also emphasized and encouraged enrollment of Black/African-American and female subjects to ensure data generation for historically underserved patient populations and in keeping with enrollment profiles achieved in previous VentureMed, AV Access studies. The study was a prospective, multi-center study in 4 sites and treated 130 patients. The primary endpoint is target lesion primary patency with patient follow-up at 6- and 12-month intervals.
