VentureMed Begins Introduction of Flex Vessel Prep 75-cm System for AV Access

October 5, 2022—VentureMed Group, Inc., which is focused on access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease, announced that the commencement of an initial limited market release of the company’s 75-cm–length Flex Vessel Prep (VP) system. The device is intended for AV access interventions, including cephalic arch stenoses.

The Flex VP 75-cm product, which will be available Q4 2022, has received CE Mark approval in Europe and FDA 510(k) clearance in the United States.

Ari Kramer, MD, treated the first patient with the 75-cm Flex device. Dr. Kramer is Assistant Professor, Department of Surgery and Director, Vascular Access Program, Spartanburg Regional Healthcare System in Spartanburg, South Carolina.

“As a physician treating AV patients who rely on uninterrupted lifesaving hemodialysis, I am always looking for new technology and solutions to solve our challenging issues in AV access,” commented Dr. Kramer in VentureMed’s press release. “I believe VP in AV access is essential for durability regardless of final therapy. The Flex VP system offers a unique nonballoon-based prep that extends patency between interventions and decreases the need for stenting. This new 75-cm device is especially beneficial for me to reach and treat the very challenging cephalic arch lesions.”

According to VentureMed, the 75-cm product was developed to address lesions in the cephalic arch region that are often hard to reach and problematic because of complicated vasculature and complex stenoses. In addition to the longer catheter, the Flex treatment element has been optimized to create even more consistent engagement in the vessel creating microincisions in the stenoses. Flex has a nonballoon-based mechanism of action that creates longitudinal microincisions releasing circumferential tension in diseased vessels.

In June 2022, the company announced that the data from the FLEX AV Access Registry clinical study were presented at the Vascular Access Societies of the Americas 2022 Vascular Access for Hemodialysis held in Charleston, South Carolina.

As summarized by the company in June, the 6-month functional patency results with Flex vessel prep included freedom from target lesion revascularization (FFTLR) and demonstrated the following:

• 71% patency for all AV fistula patients with 219 days FFTLR, compared with historical data ranging from 21.3% to 55%
• 69% patency for cephalic arch lesions with 211 days FFTLR, compared with historical data of 8% to 52%
• 47% patency for all AV graft patients with 174 days FFTLR, compared with historical data of 6% to 34%
• Excellent safety with no serious adverse events