New data presented at the 2022 Vascular Access for Hemodialysis Symposium (9–11 June, Charleston, USA) have demonstrated favourable outcomes with the Flex Vessel Prep system as compared to historical data, and “really impressive” results in the cephalic arch and in arteriovenous grafts (AVGs), according to a press release from VentureMed Group.
Findings from the FLEX Vessel Prep AV registry—a single-arm, prospective study conducted with 114 real-world patients across eight US centres—were delivered by primary investigator and Vascular Access Society of the Americas (VASA) president John Aruny (Dialysis Access Institute, Orangeburg, USA).
“AV [arteriovenous] access failure is a significant issue for patients that interrupts lifesaving haemodialysis treatments, so physicians are always searching for new options to extend time between interventions,” said Aruny. “The FLEX AV registry six-month outcomes demonstrate sustained patency across most patients and really impressive results in the cephalic arch and AV grafts over treating with PTA [percutaneous transluminal angioplasty] alone.”
Six-month functional patency and freedom from target lesion revascularisation (FFTLR) results with Flex Vessel Prep are as follows:
- Seventy-one percent patency for all AV fistula (AVF) patients—219 days FFTLR, compared with historical data ranging from 21.3 to 55%
- Sixty-nine percent patency for cephalic arch lesions—211 days FFTLR, compared with historical data of 8–52%
- Forty-seven percent patency for all AVG patients—174 days FFTLR, compared with historical data of 6–34%
The VentureMed release also details that the Flex Vessel Prep procedure demonstrated excellent safety in the AV Registry, with no serious adverse events reported.
This AV registry also set a new standard for patient diversity and inclusivity, the release continues, as more than 65% (75/114) of the patients enrolled were African American. The six-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.
“These real-world data continue to build strong evidence that the Flex Vessel Prep system is a safe and very effective vessel preparation tool in AV access over PTA alone,” said Denis Harrington, CEO and president of VentureMed. “This real-world, all-comers registry featured an extremely challenging cohort of AV access patients. The Flex AV procedure extended time between interventions for these highly compromised patients undergoing lifesaving haemodialysis therapy. VentureMed is committed to creating technologies that help extend time and reduce complications for end-stage kidney disease patients and generating clinical evidence to demonstrate these improvements.”