Vascular Graft Solutions has earned the CE Mark for its Frame FR platform, a device used to repair and stabilize aneurysmal arteriovenous fistulas in hemodialysis patients.

The device reduces and maintains flow and can minimize venous remodeling and mitigate intimal hyperplasia, a complication in which a vein or artery’s innermost layer thickens.

The device addresses one of the leading causes of morbidity and mortality in hemodialysis patients, “the toxic effect of the vascular access on the heart,” says the company’s founder and CEO, Eyal Orion.