VentureMed’s Flex Vessel Prep System Studied in Arteriovenous Fistulas

May 24, 2022—VentureMed Group, Inc. announced that it has completed enrollment in a randomized controlled trial (RCT) to assess primary patency at 6 months when using the company’s Flex vessel prep system before percutaneous transluminal angioplasty (PTA) versus PTA alone for the treatment of obstructive lesions of native arteriovenous (AV) fistulas in the upper extremity.

Investigators in the prospective FLEX Vessel Prep RCT enrolled 75 patients at seven sites across the United States. The study includes 30-day, 3-month, and 6-month follow-up.

Sanford Altman, MD, from Open Access Vascular Access in Miami Florida, commented in the company’s press release, “Although fistulas are the preferred access for hemodialysis, fistula dysfunction and failure remain a significant issue in AV dialysis access care. Balloon angioplasty is considered the gold standard by most, [but] still has its limitations due to the resistant and recurrent nature of these hyperplasic lesions, often requiring the use of high-pressure balloons.”

Dr. Altman continued, “These high-pressure balloon treatments can cause vessel wall damage, accelerating restenosis and shortening the time between interventions. By utilizing the Flex vessel prep prior to angioplasty, we are hoping to see improved vessel compliance, reducing the need for high-pressure balloons while reducing the barotrauma to the vessel wall, thereby extending the primary patency and time between interventions.”