Two Devices Gain De Novo Clearance for Hemodialysis Patients

FDA has permitted the de novo marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney disease who need hemodialysis. The devices, Avenu Medical’s Ellipsys Vascular Access System and TVA Medical’s everlinQ endoAVF System, are intended for use to make an arteriovenous (AV) fistula for patients who need hemodialysis access. An AV fistula is traditionally made by surgically joining an artery and a vein under the skin in the arm, an FDA release says. The new devices are designed to create AV fistulas percutaneously (through the skin). “A catheter is inserted into a blood vessel in the arm and is guided to the site of the planned AV fistula,” the agency says. “The devices then deliver energy to form a connection between an upper forearm artery and an adjacent vein. The Ellipsys Vascular Access System uses one catheter, the everlinQ endoAVF System uses two.”