News | April 27, 2009

Berlin Heart Receives First Regulatory Approval in North America

April 27, 2009 - Berlin Heart GmbH recently received approval in North America for the EXCOR Pediatric ventricular assist device with a License with Conditions from Health Canada, the federal department responsible for regulatory issues in Canada.

EXCOR is currently under clinical investigation for pediatric patients in the U.S.

The Berlin Heart EXCOR Pediatric is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. 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 system is designed to bridge patients awaiting heart transplantation until a donor heart becomes available, but has also 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, the company said.

For more information: www.berlinheart.com

Related Content

Sponsored Content | Videos | Cardiovascular Ultrasound| July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
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...
Italian Boy Becomes Youngest Patient Bridged to Transplant With SynCardia Total Artificial Heart

Andrei, 12, is the world’s youngest patient to be bridged to transplant with the SynCardia Total Artificial Heart. He is pictured after his heart transplant with his surgeon, Antonio Amodeo, M.D., at Bambino Gesù Children’s Hospital in Rome, Italy. Photo courtesy of Business Wire.

News | Congenital Heart| June 22, 2017
A 12-year-old boy at Bambino Gesù Children’s Hospital in Rome, Italy, has become the world’s youngest patient to be...
Abiomed Impella CP pVAD, third-generation CP
Technology | Hemodynamic Support Devices| June 12, 2017
June 12, 2017 — Abiomed Inc.
tandemLife Tandemheart priming tray cleared by FDA
Technology | Hemodynamic Support Devices| June 12, 2017
June 12, 2017 — TandemLife began its commercial launch of the TandemLife Priming Tray, a new product designed to simp
Sponsored Content | Videos | Cardiovascular Ultrasound| May 26, 2017
This video, provided in partnership with the American Society of Echocardiography (ASE), is titled "Intraoperative Tr
Impella CP study to investigate door to left ventricular unloading time
News | May 09, 2017
May 9, 2017 — The first patient has been enrolled in the U.S.
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
the Impella pVAD improves survival, mortality in AMI heart attack with cardiogenic shock

Early use of the Impella percutaneous ventricular assist device prior to angioplasty may significantly improve survival for patients in cardiogenic shock.

Feature | Hemodynamic Support Devices| April 28, 2017 | Dave Fornell
Recent clinical study data presented at the American College of Cardiology (ACC) 2017 meeting show new treatment prot
Sponsored Content | 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
Overlay Init