VentureMed Group have announced this week that it has completed enrolment of the FLEX First arteriovenous (AV) Registry, which was designed to treat subjects with AV fistulas (AVF)/AV grafts (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 emphasised and encouraged enrolment of Black/African-American and female subjects to ensure data generation for historically underserved patient populations and in keeping with enrolment profiles achieved in previous VentureMed AV access studies. The study was a prospective, multi-centre study in four sites and treated 130 patients. The primary endpoint is target lesion primary patency with patient follow-up at six- and 12-month intervals.
The FLEX Vessel Prep System has what VentureMed refers to as a “unique non-balloon-based mechanism of action” that creates longitudinal micro-incisions that release circumferential tension in diseased vessels. The company credits this “release of tension” as the reason FLEX is able to modify AV stenoses to potentially improve and extend patency with therapeutic treatments—such as drug-coated balloons (DCBs) and percutaneous transluminal angioplasty (PTA)—and may reduce complications and vessel trauma including severe dissections that can lead to bail-out stenting. The FLEX Vessel Prep System is also indicated for in-stent restenosis (ISR).
Ari Kramer (Spartanburg Regional Medical Center, Spartanburg, USA), primary investigator of the trial, stated: “Dialysis access requires constant maintenance due to its high natural failure rate. I’ve seen first-hand 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. 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.”
Denis Harrington, president and chief executive officer (CEO) of the VentureMed Group, also shared his thoughts on this recent announcement, saying: “The completion of this study comes at a very exciting time for VentureMed as we just recently received our transitional pass through payment (TPT) from CMS. We will add this data to our existing body of strong, published clinical evidence that demonstrates substantial clinical improvement over the existing standard of care (plain balloon angioplasty) and corresponding economic value for our customers.”
