Merit Medical Systems Inc. received two more breakthrough-device designations from the U.S. Food and Drug Administration for its Wrapsody endovascular stent graft system.
The South Jordan, Utah-based medical-device manufacturer is developing Wrapsody for use in dialysis patients to treat stenosis, or narrowing, within the central veins of the outflow circuit of an abnormal connection or passageway between an artery and a vein up to the superior vena cava, a venous trunk that returns deoxygenated blood from the systemic circulation to the right atrium of the heart.
The new designations cover the treatment of patients with an arteriovenous fistula, an abnormal connection in a vein and an artery, within the peripheral veins in the arm, as well as patients with an arteriovenous graft — a looped plastic tube that connects an artery to a vein — in the thoracic central veins.
Thoracic central veins include segments of the internal jugular vein, subclavian veins, brachiocephalic veins and the superior vena cava.
The FDA granted the Wrapsody endovascular stent-graft system the breakthrough-device designation in November 2019 to treat a condition in certain dialysis patients. The device is not available for sale.