News | October 16, 2008

Berlin Heart's EXCOR Pediatric VAD Approved for IDE Study

October 17, 2008 - Berlin Heart Inc. said yesterday that its EXCOR Pediatric ventricular assist device (VAD) has received unconditional approval from the FDA for IDE (investigation device exemption) study.
In 2007, the FDA had granted conditional approval for the prospective IDE study to begin initially at 10 centers with 10 patients, while the company addressed some questions the FDA had found after reviewing the study design.
The 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 short-term, mid-term, and long-term support system, supporting failing hearts from days up to several months. The pulsatile, pneumatically driven ventricular assist device can be used to support one or both ventricles.
The system is designed to bridge patients awaiting heart transplantation until a donor heart becomes available, but has also reportedly been used successfully as a bridge to recovery when a patient's heart was able to recover and work on its own again. Unlike other VADs, EXCOR Pediatric can be used to support children of all age groups, from newborns up to teenagers.
Charles D. Fraser, Jr., M.D., chief of Congenital Heart Surgery at Texas Children's Hospital, is the study's Principal Investigator. He commented, "The device shows exciting promise as a reliable option for children with no hope who are dying from heart failure. We look forward to bringing the study to completion and moving device therapies forward in children with heart disease. The need is great and growing."
The following U.S. centers are participating in the IDE study: 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), Children's Hospital at the University of Alabama at Birmingham (AL), and the University of Minnesota at Fairview (MN).
For more information: www.berlinheart.com

Related Content

Medtronic HeartWare HVAD System Approved for Destination Therapy
Technology | Ventricular Assist Devices (VAD)| October 04, 2017
October 4, 2017 — Medtronic received U.S.
Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure
Technology | Ventricular Assist Devices (VAD)| September 28, 2017
Abiomed Inc. recently received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP ...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD)| August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Pre-PCI Impella 2.5 Insertion Improves Survival in Left Main Coronary Artery Heart Attacks
News | Ventricular Assist Devices (VAD)| June 30, 2017
Abiomed Inc. announced the recent publication of a peer-reviewed retrospective study on hemodynamic support with the...
Heartware HVAD recall for its ventricular assist device from Medtronic
Feature | Ventricular Assist Devices (VAD)| May 05, 2017
May 5, 2017 — Medtronic Mechanical Circulatory Support is expanding its recall of its HeartWare Ventricular Assist De
Videos | Ventricular Assist Devices (VAD)| April 14, 2017
A discussion with William O'Neill, M.D., FACC, FSCAI, medical director of the Center for Structural Heart Disease at
Henry Ford Hospital, Detroit Cardiogenic Shock Initiative, Impella pump, ACC.17 clinical study
News | Ventricular Assist Devices (VAD)| April 03, 2017
Hospitals can dramatically increase heart attack survival rates in patients suffering cardiogenic shock by providing...
Metro Detroit cardiologists, increased heart attack survival rate, Impella heart pump, Detroit Cardiogenic Shock Initiative
News | Ventricular Assist Devices (VAD)| March 09, 2017
Metro Detroit cardiologists from five health systems have joined together to increase residents’ survival rate from...
Impella 2.5 heart pump, high-risk PCI, HRPCI, acute kidney injury risk, AKI, Circulation Research study, Abiomed
News | Ventricular Assist Devices (VAD)| March 09, 2017
A new study published in Circulation Research finds use of hemodynamic support with the Impella 2.5 heart pump during...
James Ward, LVAD surgery, left ventricular assist device, UAB, University of Alabama at Birmingham
News | Ventricular Assist Devices (VAD)| March 08, 2017
Congestive heart failure patients at the University of Alabama at Birmingham (UAB) now have reason for optimism with a...
Overlay Init