TVA Medical announced on 25 March 2015 promising results from a clinical study evaluating a novel haemodialysis access technique for patients with chronic kidney disease. The clinical results of TVA Medical’s everlinQ System were published online in the Journal of Vascular and Interventional Radiology.
The FLEX study evaluated the safety and efficacy of the everlinQ system to create an arteriovenous fistula in a percutaneous procedure for patients with chronic kidney disease. The everlinQ system has been studied outside the United Statesand and has received the CE mark. The product is not currently available in the United States and has not been evaluated by the FDA.
Of 33 study patients, technical procedural success was achieved in 97% of cases, and 96% of study patients had a usable and patent arteriovenous fistula at six months, with minimal need for additional intervention. The average time to a usable arteriovenous fistula for haemodialysis was 58 days.
“The results demonstrate that the everlinQ System can create arteriovenous fistulae that are usable for dialysis and resist closure,” said Dheeraj Rajan, an investigator of the FLEX study and head of Vascular and Interventional Radiology at University of Toronto, Canada. “I am optimistic as we continue to study the impact the product has on infections, patient discomfort, the need for additional interventions, and healthcare costs.”
Currently there are no percutaneous arteriovenous fistula haemodialysis access methods approved for commercial use by the FDA.
“Millions of chronic kidney disease patients rely on haemodialysis therapy to stay alive and there is a major unmet need for a simpler and more effective means to provide them with vascular access,” said Adam L Berman, CEO of TVA Medical. “We remain dedicated to building clinical evidence to document the potential benefit of everlinQ for dialysis patients.”
The everlinQ system creates an arteriovenous fistula using a minimally-invasive approach. In the procedure, two thin, flexible magnetic catheters are inserted into an artery and vein in the arm. A small burst of radiofrequency energy is used to connect the artery and vein to create the fistula, and the catheters are removed. The everlinQ system has the potential to enable patients to use their arteriovenous fistula for haemodialysis within two months. The everlinQ system is currently being studied in the NEAT (Novel Endovascular Access Trial) clinical study in Canada, Australia and New Zealand.