Berlin Heart

Berlin Heart GmbH, founded in 1997 and headquartered in Germany with a key North American subsidiary in The Woodlands, Texas, is a global leader in pediatric mechanical circulatory support. Its flagship product, the EXCOR® Pediatric, is the first and only FDA-approved ventricular assist device for children, serving as a critical bridge to transplant for pediatric patients with severe biventricular or left ventricular dysfunction. The company focuses on innovative, reliable VAD technology for patients of all ages, leveraging strategic partnerships with leading heart centers to support its clinical and commercial expansion.

Paracorporeal, pulsatile ventricular assist devices (VADs) with pneumatically driven blood pumps for pediatric and adult patients.

In the pediatric VAD space, Berlin Heart's EXCOR® Pediatric faces little direct competition in the U.S. due to its unique FDA approval. However, in the broader VAD market, it competes indirectly with adult-focused devices from Abbott (HeartMate) and Medtronic. The primary competitive threat is future innovation from these large players or startups developing miniaturized, implantable pumps for children.