Preliminary data presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual scientific meeting (14–18 September, Barcelona, Spain) demonstrated that TVA Medical’s vascular catheter-based FLEX System can create autogenous arteriovenous fistulas (AV fistulas) for haemodialysis patients with 94% procedural success.
The technology is being studied outside of the USA and is currently not available in that territory.
Surgical AV fistulas are the current gold-standard for haemodialysis access, but they are plagued by high failure rates and frequent revisions resulting in enormous healthcare costs. Patients receiving surgical AV fistulas require an average of two to three additional interventions to achieve a usable fistula, which can delay availability of the AV fistula for haemodialysis by five to twelve months. Additionally, 30–60% of AV fistulas are never usable for dialysis, despite numerous re-interventions.
“The preliminary results of this first in human study demonstrate that we can create usable autogenous AV fistulas without open surgery,” said Dheeraj K Rajan, an investigator of the FLEX-1 study and head of Vascular and Interventional Radiology, University of Toronto, Canada. “Moving to an entirely percutaneous procedure for vascular access has the potential to dramatically improve patient care by improving fistula usability, reducing surgical wait times, and reducing complications and costs.”
“Overall, we are very pleased with the outcomes demonstrated in this clinical study,” said Adrian Ebner, principal investigator of the FLEX-1 study and chief of Cardiovascular Services at the Italian Hospital, Asuncion, Paraguay. “Many of these patients were dependent on central venous catheters, and now have a functioning permanent vascular access delivered using a minimally-invasive procedure. I believe many patients worldwide will benefit from this procedure.”
The FLEX-1 Pilot Study is a non-randomised, prospective study on the feasibility of using the FLEX System to create AV fistulas in patients with kidney failure requiring haemodialysis without open surgery. Sixteen patients were enrolled in the initial cohort and followed for three months. Additional follow-up is ongoing.
“Two million people worldwide rely on haemodialysis three times a week to sustain life, and many are subjected to multiple procedures and long duration on infection-prone catheters while they wait for a permanent workable AV fistula. There is an unmet need for a reliable, reproducible method to connect patients to the dialysis machine in a timely manner,” said Adam L Berman, CEO of TVA Medical. “We believe our technology has the potential to benefit haemodialysis patients around the world.”