Vascular Graft Solutions, a company based in Tel Aviv, Israel, has won the European CE Mark for its FRAME FR device for repair and support of high flow and aneurysmal arteriovenous fistulas. These are created in hemodialysis patients to allow for more blood to flow through a vein and give easy access for dialysis needles.
Although a properly performed fistula can work for many years, in many patients they tend to dilate and create all kinds of problems, including increased toxicity for the heart. These so-called high flow fistulas are difficult to maintain.
The FRAME FR device keeps blood flow within a reasonable rate, reducing pressure on the fistula and hopefully reducing negative effects. In an initial study, presented last spring at the April 2019 Vascular Access Society meeting, the researchers noted that when using the device ” ..flow rates were markedly reduced postoperatively in all patients with an average reduction of 69% to normal flow, with all patients reporting relief in their cardiopulmonary symptoms.”
“We are excited to launch the FRAME FR platform, a holistic solution for repair, stabilization and prevention of recurrent vascular access disease,” said Dr. Eyal Orion, founder and CEO of Vascular Graft Solutions, in a press release. “In the past 10 years, we have become a global leader in developing and commercializing external supports for the 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. Our solution reduces and maintains the flow within a normal range and has potential to minimize venous remodeling and mitigate intimal hyperplasia as shown in different pre-clinical and clinical settings studying external support of vein grafts.”