VentureMed’s Flex Vessel Prep System Evaluated in FLEX AV Access Registry

June 15, 2022—VentureMed Group, Inc., a privately held medical device company focused on access management for arteriovenous (AV) fistulas, grafts, and vessel preparation for interventional treatment of peripheral arterial disease, announced data for the company’s Flex vessel prep system.

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 June 9-11 in Charleston, South Carolina.

According to the company, the single-arm, prospective clinical study was conducted at eight centers in the United States and enrolled 114 real-world patients.

The study’s Primary Investigator is John Aruny, MD, with Dialysis Access Institute in Orangeburg, South Carolina.

“AV access failure is a significant issue for patients that interrupts lifesaving hemodialysis treatments, so physicians are always searching for new options to extend time between interventions,” commented Dr. Aruny in the company’s press release. “The FLEX AV Registry 6-month outcomes demonstrate sustained patency across most patients and really impressive results in the cephalic arch and AV grafts over treating with percutaneous transluminal angioplasty alone.”

The company reported that 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%.

Additionally, the Flex vessel prep procedure demonstrated excellent safety in the AV Registry with no serious adverse events reported.

The FLEX AV Access Registry also achieved significant patient diversity and inclusivity with African American patients comprising more than 65% (75/114) of total patients enrolled. The 6-month safety and patency results for African American patients treated with Flex vessel prep were equal to or better than the total patient pool for all recorded measurements, noted the company.