Healthcare Industry News:  ventricular assist device 

Devices FDA Cardiology

 News Release - May 16, 2007

Berlin Heart's EXCOR(R) Pediatric Receives Conditional Investigational Device Exemption (IDE) Approval

EXCOR® Pediatric VAD receives Conditional IDE Approval
10 centers with 10 patients initially approved for study


BERLIN--(Healthcare Sales & Marketing Network)--May 16, 2007 -- Berlin Heart GmbH today announced its EXCOR® Pediatric ventricular assist device (VAD) has received conditional approval for IDE purposes in the United States of America. The U.S. Food and Drug Administration has granted conditional approval for the prospective IDE study to begin initially at 10 centres with 10 patients.

EXCOR® Pediatric is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. Unlike standard heart-lung machines, EXCOR® Pediatric has been used as a medium- to long-term support system, supporting failing hearts for up to several months.

The system has been designed to bridge patients awaiting a heart transplant until a donor heart becomes available, but has also succeeded as a bridge to recovery when a patient's heart was able to recover and work on its own again.

Dr. Rolf Kaese, the company's CEO, states: "We are very pleased to have received the FDA's Conditional IDE Approval which we hope to extend to an Unconditional IDE Approval in the near future. The Berlin Heart EXCOR® Pediatric fills a real void as it provides cardiac assist to the smallest patients for whom no real alternative exists."

Berlin Heart has proposed the following initial IDE centers: Arkansas Children's Hospital (AR), Boston Children's Hospital (MA), Children's Hospital of Wisconsin (WI), Lucille Packard Children's Hospital at Stanford (CA), Mott Children's Hospital (MI), Riley Children's Hospital (IN), Seattle Children's Hospital (WA), St. Louis Children's Hospital (MO), Texas Children's Hospital (TX), and the Children's Hospital at the University of Alabama at Birmingham (AL).

The proposed principal investigator of the Berlin Heart EXCOR® Pediatric VAD Study is Dr. Charles D. Fraser, Jr., Chief of Congenital Heart Surgery at Texas Children's Hospital. The proposed Co-Principal Investigator is Dr. Christopher Almond, Assistant in Cardiology at the Children's Hospital Boston.

About EXCOR® Pediatric

EXCOR® Pediatric is a pulsatile, pneumatically driven ventricular assist device and can be used to support one or both ventricles. EXCOR® Pediatric has been used in a total of 285 pediatric patients ranging from newborns with 2 kg to teenagers with 90 kg body weight. The system has been used 96 times in North America; with the FDA granting permission on a compassionate use basis.

About Berlin Heart

Berlin Heart GmbH is the only company worldwide offering ventricular assist devices for patients of every age and body size. The company manufactures pumps, cannulas, and external components for internal and external use to stabilise cardiac activity in acutely ill patients. Its products INCOR®, EXCOR® and EXCOR® Pediatric are market leaders in their respective segments in Germany and in Europe. Berlin Heart Inc., the company's US subsidiary, was founded in 2005 and supports North American centers in emergency cases. Further product information is available from the company website: www.berlinheart.com.


Source: Berlin Heart

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