News | November 18, 2011

Clinical trial shows Pediatric VAD Successfully Bridged 90 Percent of Children

November 18, 2011 —The Berlin Heart Group announced today that clinical trial data were presented this morning at the “Scientific Sessions 2011” annual meeting of the American Heart Association (AHA). These data showed that, in a clinical trial of children with severe heart failure who were waiting for a heart transplant, 90 percent of patients in the primary cohort of the study were successfully bridged to a heart transplant using Berlin Heart Excor pediatric ventricular assist device (VAD).

On July 21, 2011, the Circulatory Systems Devices Advisory Panel recommended that the FDA grant humanitarian device exemption (HDE) approval of the Berlin Heart Berlin Heart Excor pediatric VAD: "... there is a definite benefit of this device to support critically ill children awaiting heart transplantation." Excor is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. The system is designed to support pediatric patients of all age groups, from newborns to teenagers, and is intended to bridge patients awaiting heart transplantation from days up to several months, until a donor heart becomes available. Excor, which is approved for use in Europe and Canada, is the only VAD that is designed specifically for the pediatric population to be unanimously recommended for approval in the United States.

“This was a landmark clinical study of children suffering from end-stage heart disease,” said Christopher S. D. Almond, M.D., department of cardiology, Children’s Hospital Boston, the primary pediatric teaching hospital of Harvard Medical School, and co-principal investigator of the Excor clinical trial. “Based on these data, the advisory panel has recommended that the FDA grant approval of the Excor pediatric VAD, which would mean that the medical community would be able to offer a lifesaving alternative to severely ill children who would not likely survive while waiting for a heart transplant. Excor will usher in a new era for treating children with end-stage heart disease."

For more information: www.berlinheart.com

 

 

Related Content

Lexington Begins HeartSentry Clinical Trial
News | Clinical Study | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Clinical Study | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Clinical Study | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Clinical Study | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Clinical Study | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Clinical Study | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init