Early Data Presented for Medtronic's Harmony Transcatheter Pulmonary Valve

April 7, 2016—Medtronic plc announced that clinical data from the early feasibility study of the Harmony transcatheter pulmonary valve (TPV) demonstrate positive initial outcomes at 6 months in patients with an indication for pulmonary valve restoration. The initial results were presented at ACC.16, the American College of Cardiology’s 65th Annual Scientific Session held April 2-4 in Chicago, Illinois. The company advised that it will start a pivotal investigational device exemption study in late 2016, pending approval from the US Food and Drug Administration.

The first-of-its-kind early feasibility study was initiated by Medtronic in collaboration with the US Food and Drug Administration in an effort to develop a minimally invasive alternative to open-heart surgery for patients with congenital heart disease (CHD). Approximately one in five patients born with CHD have an abnormality of their right ventricular outflow tract, noted the company.

John Cheatham, MD, presented the data at ACC.16. Dr. Cheatham is Director of Cardiac Catheterization and Interventional Therapy and Codirector of The Heart Center at Nationwide Children's Hospital in Columbus, Ohio.

In Medtronic’s press release, Dr. Cheatham commented, “Through precise patient selection, the early feasibility data enables the clinical community to gather several key insights that will help to determine the valve's therapeutic benefits in this patient population. Due to its unique design and ability to adapt to a wide variety of patient anatomies. The Harmony TPV and its future iterations may provide a broad range of CHD patients with a minimally invasive treatment option that allows for shorter procedural time and hospital stay.”

The Harmony TPV is not available in the United States and is available for investigational use only. The minimally invasive CHD technology builds off of the company’s Melody TPV platform, which was approved in February 2015.