VentureMed’s FLEX First AV Registry Enrolls First Patient to Study Treatment of Arteriovenous Access Management

December 15, 2022—VentureMed Group, Inc. announced the commencement of enrollment in the FLEX First AV registry to evaluate arteriovenous (AV) access management with the company’s Flex Vessel Prep (VP) system. The Flex VP system has CE Mark approval and FDA 510(k) clearance.

According to the company, the study will enroll up to 400 patients at up to 15 sites. The primary endpoint is target lesion primary patency with patient follow-up at 6- and 12-month intervals.

FLEX First will be composed of patients treated with AV fistula or AV graft stenosis in order to demonstrate that the Flex VP system combined with balloon angioplasty will improve the rate of target lesion primary patency as compared with published rates of balloon angioplasty alone.

Additionally, the study will also emphasize and encourage enrollment of Black 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, noted the company.

Sanford Altman, MD, Founder and Medical Director of Open Access Vascular Access in Miami, Florida, treated the first patient in the FLEX First AV registry.

“Maintaining AV access in end-stage renal disease patients can be challenging,” commented Dr. Altman in the company’s press release. “Prolonging access patency is always the goal for these patients; however, this is not often easily achieved. We are excited about utilizing the Flex Vessel Prep system in hopes that it will extend our patients’ access patency, allowing them more time between interventions.”

FLEX First is the company’s second AV registry. In June 2022, VentureMed Group announced that data from the FLEX AV Access registry were presented at the Vascular Access Societies of the Americas 2022 Vascular Access for Hemodialysis meeting held June 9-11 in Charleston, South Carolina. The single-arm, prospective clinical study was conducted at eight centers in the United States and enrolled 114 real-world patients.

In October 2022, the company announced an initial limited market release of the 75-cm–length Flex VP system for AV access interventions, including cephalic arch stenoses.

VentureMed’s Flex VP device is designed with a nonballoon-based mechanism of action that creates longitudinal microincisions that release circumferential lesion tension in diseased vessels, allowing lower balloon inflation pressures. This treatment potentially enhances drug delivery with drug-eluting therapies to improve patency and time between interventions.

The tension release allows Flex to modify AV stenoses safely and effectively to improve and extend patency for all therapeutic treatments; reduce complications and vessel trauma, including explosive dissections that can lead to bail-out stenting; treat in-stent restenosis; and improve health economics, stated the company.