800 “EXCOR® Pediatric” implants worldwide: The life-saving ventricular assist device for children.

Berlin, Germany. 29 October 2010. This month, the 800th Berlin Heart EXCOR® Pediatric ventricular assist device was implanted in a child suffering from severe heart failure. For the pediatric population with severe heart failure, whose hearts do not provide them with the necessary pump function; mechanical circulatory support with the Berlin Heart device can provide life-saving therapy while these little patients desperately await heart transplantation.

The device is unique worldwide, with its wide product range of different pump and cannulae sizes specifically designed for the pediatric population to meets the needs of children with severe heart failure of varying causes. No other system offers newborns, toddlers and adolescents the possibility to bridge the time until a matching donor heart becomes available. The 800th patient, a 7 month old child, had recently undergone cardiac surgery in the USA at the Lucille Packard Children's Hospital at Stanford University. Since birth, the child was suffering from severe heart failure despite the surgery and medical therapy prompting the patient’s physicians to place him on the Berlin Heart.

The device is approved for use in Europe and available worldwide. In the USA EXCOR® Pediatric is currently under clinical investigation and not yet approved by the FDA. However, as there is no other viable bridge to transplant therapy available for children in the US, the device can be accessed under the Compassionate Use Regulations with approval granted by the FDA on a case by case basis.

For many years artificial and mechanical circulatory support systems have been developed and implanted but only within recent years has the therapy become widely accepted. As a treatment for acutely ill patients with severe heart failure the therapy is restricted to specialized pediatric cardiac surgical centers with pediatric cardiac transplant programs.

On average, children are supported with the EXCOR® Pediatric system for 3 – 4 months before a donor heart becomes available. However, support times have been increasing due to a decline in the availability of donor organs. The longest time of support with the device as a bridge to transplantation is 2.5 years, and the youngest patient to be supported only few days old.

About Berlin Heart
Berlin Heart GmbH is the only company worldwide that develops, produces, and distributes implantable and external ventricular assist devices for patients of every age and body size.
The company offers pumps, cannulae, and external components for internal and external circulatory support of acutely ill patients. The company and its products are market leaders in their respective segments in Germany and in Europe.
The company manufactures INCOR®, an implantable left ventricular assist device which is designed for long-term support in the adult population with heart failure. INCOR® is not FDA-approved, but widely used in Europe. Berlin Heart Inc., the company’s US subsidiary, was founded in 2005 to support the North American activities.

Berlin Heart GmbH
Kerstin Unkel
Marketing & PR
Wiesenweg 10
12247 Berlin
unkel@berlinheart.de

Berlin Heart Inc.
Bob Kroslowitz
200 Valleywood
Suite A500
The Woodlands
TX 77380
USA
kroslowitz@berlinheart.de

This release was published on openPR.