FLEX Study Data Published on TVA Medical's Everlinq System for Hemodialysis Access

March 25, 2015—TVA Medical, Inc. announced that results from the FLEX clinical study of its Everlinq system indicate the device could be a promising new method of vascular access for patients with chronic kidney disease without the use of traditional open surgery. The clinical results of the FLEX study were published by Dheeraj Rajan, MD, et al in the Journal of Vascular and Interventional Radiology (2015; 26:484–490).

According to TVA Medical, the FLEX study evaluated the safety and efficacy of the Everlinq system for creating an arteriovenous fistula (AVF) during a percutaneous procedure for patients with chronic kidney disease. FLEX-1-001 enrolled 16 patients, and FLEX-1-002 enrolled 17 patients. Of the 33 total study patients, technical procedural success was achieved in 97%, and 96% had a usable and patent AVF at 6 months, with minimal need for additional intervention. The average time to a usable AVF for hemodialysis was 58 days. 

In the company’s press release, Dr. Rajan commented, “The results demonstrate that the Everlinq system can create AVFs that are usable for dialysis and resist closure. I am optimistic as we continue to study the impact the product has on infections, patient discomfort, the need for additional interventions, and health care costs,” Dr. Rajan is Head of Vascular and Interventional Radiology at University of Toronto in Canada.

The Everlinq system creates an AVF using two thin, flexible magnetic catheters that 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 company stated that the Everlinq system has the potential to enable patients to use their AVF for hemodialysis within 2 months. 

The company advised that the Everlinq system has been studied outside the United States and has received European CE Mark approval. Everlinq is currently being studied in the NEAT (Novel Endovascular Access Trial) clinical study in Canada, Australia, and New Zealand. 

TVA Medical noted that is an investigational device and is not currently available in the United States, and it has not been evaluated by the US Food and Drug Administration.