Healthcare Industry News:  dialysis 

Devices Regulatory

 News Release - August 5, 2019

Vascular Graft Solutions Announces CE Mark Approval for FRAME FR External Support for AV Fistula Repair

TEL AVIV, Israel, Aug. 5, 2019 -- (Healthcare Sales & Marketing Network) -- VGS - Vascular Graft Solutions Ltd. announced today it has received CE Mark Approval for the FRAME FR, a novel solution for repair and stabilization of high flow and aneurysmal arteriovenous fistulas in hemodialysis patients.

Although AV fistula is the preferred access for hemodialysis, up to 25% of patients with functional access will develop high flow AV fistulas (>1.5 liters/min) which are usually accompanied by pathological dilatation of the vein and toxic effects on the heart. To date, there is no effective solution for long term, stable modulation of flows in patients with high flow AV fistula. This condition is frequently underdiagnosed in dialysis units and once treated, many patients have to undergo several interventions to maintain the desired flow and avoid the effect on the heart.

"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 VGS. "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. Our solution reduces and maintains the flow within 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".

Clinical experience with FRAME FR was presented in April 2019 at the Vascular Access Society (VAS) in Rotterdam and the Charing Cross meeting in London by Dr. Vladimir Matoussevitch, head of vascular access unit at the university hospital of Cologne, Germany. Dr. Matoussevitch presented results of a study cohort which demonstrated the safety and effectiveness of FRAME FR in providing stable flow reduction. 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. Long term clinical follow up is going to be presented by Dr. Matoussevitch at the VEITH meeting in NY on November 2019.

Source: Vascular Graft Solutions

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