Vascular Graft Solutions today announced that it received CE Mark approval for its Frame FR external support for AV fistula repair.

“We are excited to launch the Frame FR platform, a holistic solution for repair, stabilization and prevention of recurrent vascular access disease,” founder and CEO Eyal Orion said in a press release. “In the past 10 years, we have become a global leader in developing and commercializing external supports for prevention of vein graft disease in coronary and peripheral bypass. After extensive pre-clinical and clinical research, we are glad to expand our solutions to hemodialysis patients and hope to address one of the leading causes of morbidity and mortality in these patients – the toxic effect of the vascular access on the heart.”

The Tel-Aviv-based company present clinical experience data using the Frame FR system in April at the Vascular Access Society meeting. The system showed stable flow reduction and flow rates were reduced postoperatively in all patients who had an average reduction of 69% to normal flow. All patients reported relief in their cardiopulmonary symptoms, according to Vascular Graft Solutions.

“Our solution reduced and maintains the flow within normal range and has the potential to minimize venous remodeling and mitigate intimal hyperplasia as shown in different pre-clinical and clinical settings studying external support of vein grafts,” Orion said.