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Berlin Heart GmbH is a German company that develops, produces and markets ventricular assist devices (VADs). The devices mechanically support the hearts of patients with end-stage heart failure. Berlin Heart's products include the implantable INCOR VAD and the paracorporeal EXCOR VAD. To date, Berlin Heart produces the only device of its kind available for babies and children with severe heart failure.
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History
In 1996, Mediport Kardiotechnik GmbH was founded by the German Heart Institute Berlin and was supported by private investors. Four years later, in 2000, Berlin Heart AG was founded after merging with its predecessor company, Mediport Kardiotechnik GmbH. The U.S. subsidiary, Berlin Heart Inc., was established in Texas in 2005. Due to a long-term private investor, Berlin Heart changed its legal structure in 2006 to a limited liability company (GmbH).
Products
Berlin Heart manufactures two types of VADs: implantable and paracorporeal.
INCOR is an axial-flow pump for support of the left ventricle. In this system, the pump is implanted directly next to the heart and is connected to the heart by cannula. The blood coming from the heart flows into the INCOR axial pump. The rotor in the pump has an active magnetic bearing while floating contact-free. Due to the rotation, up to eight liters of blood per minute are continuously pumped through the body. A percutaneous driveline connects the pump with the external controller. The control unit and the two batteries are carried in a shoulder-bag.
EXCOR is a paracorporeal, pulsatile flow VAD. The device provides left ventricular, right ventricular or biventricular assistance. The EXCOR system includes paracorporeal, pneumatically-driven polyurethane blood pumps. Each pump consists of a blood chamber and an air chamber which are separated by a multilayer flexible membrane. The movement of air in and out of the air chamber is controlled by a driving unit. It moves the membranes, which draw blood into the blood chamber and push it back into the body. Like the heart, EXCOR blood pumps have valves which ensure that the blood only flows in one direction. The blood pumps are connected to the heart and blood vessels via silicone cannula.
The EXCOR product range covers blood pumps and cannula of various sizes and types. While EXCOR Adult is specifically designed for adults, EXCOR Pediatric includes devices for young patients (from newborns to adolescents).
Milestones
Studies
EXCOR Pediatric Prospective Trial of a Pediatric Ventricular Assist Device
The prospective, multicenter, single-arm study consisted of two cohorts, divided according to body surface area (BSA): cohort 1 BSA <0.7 m2, cohort 2 BSA >0.7 to <1.5 m2. Survival in the two cohorts was compared with survival in two propensity-score-matched historical control groups (one for each cohort, n=48) undergoing extracorporeal membrane oxygenation (ECMO) as a bridge to heart transplantation selected from the ELSO registry. The primary endpoint for the EXCOR Pediatric VAD was time to death or weaning with an unacceptable neurologic outcome, while the primary endpoint for the ECMO group was time to death (no data on neurologic status is available in the ELSO database). The Kaplan–Meier survival curves for EXCOR Pediatric patients were significantly better for each cohort when compared to their respective ECMO control group. Overall, for patients supported with EXCOR Pediatric VAD, 88% in cohort 1 and 92% in cohort 2 were bridged to transplant or recovery with acceptable neurological outcome.
Locations
Berlin Heart's headquarters is in Berlin, Germany, where all products and equipment are also manufactured. The wholly owned Berlin Heart, Inc. in The Woodlands, Texas provides support for implanting centers in the United States and Canada.