TVA Medical, a medical device company focused on endovascular innovation, has announced that its vascular catheter-based Flex system for hemodialysis access has demonstrated success in the FLEX-1 pilot study.
Recently, the company presented preliminary data from the FLEX-1 study at the Cardiovascular and Interventional Radiological Society of Europe annual scientific meeting and the study demonstrated that the Flex system can create autogenous arterio-venous fistulas (AV fistulas) for hemodialysis patients with 94% procedural success.
A total of 16 patients have been enrolled in the initial cohort and followed for three months in the non-randomized, prospective FLEX-1 pilot study that is being carried out to determine the feasibility of using the Flex system for creating AV fistulas in patients with kidney failure requiring hemodialysis without open surgery.
The Flex system utilizes two vascular catheters that incorporates magnets and a radiofrequency (RF) electrode and these catheters are delivered percutaneously to an artery and vein in the arm.
When these catheters are magnetically aligned and positioned under fluoroscopy, RF energy is delivered to create an arteriovenous fistula without open surgery, while leaving behind no implant.
The technology is being studied outside of the US and the company plans to obtain the Food and Drug Administration clearance for the Flex system in the future.