Vascular Graft Solutions reports first clinical use of its FRAME external support technology for aneurysm repair in high flow arteriovenous (AV) fistulas.
The first 5 cases were performed by Dr. Vladimir Matoussevitch from Cologne University Hospital in Germany.
“Autogenous AV fistula access for hemodialysis is a routine surgical procedure,” said Dr. Matoussevitch. “However, development of high flow AV fistula and aneurysmal enlargement are not uncommon complications with severe clinical and cosmetic impact on patients. High flow AV access increases cardiac output, which may lead to eccentric left ventricular hypertrophy, a key factor in the development of congestive heart failure in hemodialysis patients. In addition, aneurysmal enlargements are at high risk to develop active bleeding, rupture and infection.”
FRAME is a CE marked, kink resistant, cobalt chromium external support indicated for peripheral arterial bypass and reconstructions surgeries. In AV fistula reconstruction surgery, the aneurysm sac is resected and the vein diameter is reduced to 5-6mm. After downsizing, FRAME was applied over the repaired vein to prevent future dilatation and recurrence of aneurysm. Limiting the AV fistula outflow with FRAME, may also prevent development of high flow fistula and heart failure.
“FRAME is a simple and elegant tool that takes minutes to implant and has the potential to prevent serious clinical complications,” continued Dr. Matoussevitch. “In the initial cohort of high flow fistulas, we treated so far, the post procedure flow was reduced dramatically. I am looking forward to expand our knowledge about this new technique and its effect on hemodialysis patients.”
“We would like to thank Dr. Matoussevitch for leading this innovative approach of treating high flow fistulas with FRAME technology,” said Dr. Eyal Orion, founder and CEO of VGS. “To date, FRAME was used with great success in different peripheral reconstruction procedures that required support of venous segments. We are looking forward to working together with vascular surgeons to expand our experience with FRAME.”