Medtronic, a healthcare products company based in Minneapolis, Minnesota, announced that it received approval from the United States Food and Drug Administration for an early feasibility trial of its novel outflow tract transcatheter pulmonary valve. Medtronic received approval for the early-stage study through a new program at the federal watchdog agency.
According to a press release by the company, the tarnscatheter pulmonary valve (TPV) is for patients who were born without a conduit between their right ventricle and pulmonary artery. This conduit helps the circulatory system provide blood to the lungs. The device will serve as a safer alternative to traditional open heart surgery.
Dr. John Liddicoat is the president of the cardiovascular division at Medtronic. In prepared remarks, he said, "The approval of this study is an excellent example of how the FDA and manufacturers can work together to advance medical innovation by studying initial device design and functionality, with the long-term goal of delivering novel therapies to patients in need.”