Cardiac Assist’s Protek Duo emergency cannula has been granted CE Mark approval, the Pittsburgh, Pa., devicemaker announced last week.
The device uses a minimally invasive percutaneous process to administer veno-venous extracorporeal life support for patients with acute respiratory disease syndrome. The cannula is inserted into the jugular vein and can both drain and re-infuse blood, the company says.
An emerging therapy for ARDS, VV ECLS is designed to increase efficacy by directly infusing oxygen into the blood through an oxygenator. In a clinical trial of 180 ARDS patients, VV ECLS therapy demonstrated a 31 percent reduction in patient death and disability when evaluated against the standard of care, the devicemaker claims.
Health professionals can use the Protek Duo in conjunction with Cardiac Assist’s TandemHeart life support system, which provides up to 30 days of circulatory support, the company says.
Last May, the FDA issued a warning letter against Cardiac Assist, claiming the devicemaker did not report the death of a patient using the TandemHeart pump. The FDA deemed the company’s response sufficient and the matter was resolved.
The National Heart, Lung and Blood Institute estimates that 190,000 people in the U.S. are afflicted with ARDS. — Jason Scott