VentureMed’s FLEX First AV Registry Completes Enrollment

July 30, 2024—VentureMed Group, Inc., which is focused on access management for arteriovenous (AV) fistulas (AVFs) and grafts (AVGs) and vessel preparation for interventional treatment of peripheral arterial disease, announced it has completed enrollment of the FLEX First AV registry.

According to the company, the registry was designed to demonstrate that treating patients with AVF/AVG stenosis using the VentureMed Flex vessel prep (VP) system combined with balloon angioplasty improves the rate of target lesion primary patency as compared with comparable published rates of balloon angioplasty alone.

The prospective, multicenter study treated 130 patients who were enrolled at four sites. The primary endpoint is target lesion primary patency with patient follow-up at 6- and 12-month intervals.

VentureMed noted that enrollment in this study emphasized and encouraged enrollment of Black/African American patients and female patients to ensure data generation for historically underserved patient populations and in keeping with enrollment profiles achieved in previous VentureMed AV access studies.

“Dialysis access requires constant maintenance due to its high natural failure rate,” commented Ari Kramer, MD, in the VentureMed press release. “I’ve seen firsthand how the Flex system can transform patient care. By reducing balloon pressures by one-third to one-half in many cases, Flex can make procedures more durable, less traumatic, and less painful.”

Dr. Kramer, who is primary investigator and chief of AV surgery and interventions at Spartanburg Regional Medical Center in Spartanburg, South Carolina, added, “This isn’t just about technology; it’s about improving the lives of dialysis patients, helping them endure fewer interventions and experience a better quality of life.”

VentureMed stated that the Flex VP system’s nonballoon-based mechanism of action creates longitudinal micro-incisions that release circumferential tension in diseased vessels. With this release of tension, Flex modifies AV stenoses to potentially improve and extend patency with therapeutic treatments (percutaneous transluminal angioplasty, drug-coated balloon, etc.), and may reduce complications and vessel trauma including severe dissections that can lead to bail-out stenting. The Flex VP system is also indicated for in-stent restenosis.

The Flex VP system has received FDA 510(k) clearance in the United States and CE Mark approval in the European Union, advised VentureMed.