Navigation Links
Berlin Heart's EXCOR(R) Pediatric Receives Unconditional Investigational Device Exemption (IDE) Approval
Date:10/16/2008

BERLIN, October 16 /PRNewswire/ -- Berlin Heart Inc. today announced its EXCOR(R) Pediatric ventricular assist device (VAD) has received unconditional approval for the ongoing IDE clinical trial in the United States of America. The U.S Food and Drug Administration (FDA) has fully approved the Investigational Plan for the IDE study of the device.

In 2007, the FDA had granted conditional approval for the prospective IDE study to begin initially at 10 centres with 10 patients, while the company addressed some questions the FDA had found after reviewing the study design. "The FDA has worked effectively with Berlin Heart to refine the design of the trial to optimize the potential for a meaningful study with useful conclusions," stated Bob Kroslowitz, Vice President of Clinical Affairs for North America at Berlin Heart.

The Berlin Heart 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 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.

Sven-Rene Friedel, the company's CEO, comments, "The FDA's Unconditional Approval of the IDE study represents a major milestone for the company. The approval moves us closer to our goal of making the device more readily available in the US." Bob Kroslowitz adds, "The study is progressing extremely well and we are confident it will provide positive results. Our next step is to activate the remaining IDE study sites."

Dr. Charles D. Fraser, Jr., 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 US 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).

About EXCOR(R) Pediatric

EXCOR(R) Pediatric is a pulsatile, pneumatically driven ventricular assist device and can be used to support one or both ventricles. EXCOR(R) Pediatric has been used in a total of 441 pediatric patients ranging from newborns with 2 kg body weight to teenagers. The system has been used 174 times in North America; with the FDA granting permission on a compassionate use basis when the patient was not included in the ongoing IDE study.

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, cannulas, and external components for internal and external use to stabilise cardiac activity in acutely ill patients. Its products are market leaders in their respective segments in Germany and in Europe.

The company also manufactures the implantable left ventricular assist device INCOR(R), which has been designed for long-term application in adult patients. The longest the device has supported a patient so far is more than five years and ongoing. 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 centers. Further product information is available from the company website: http://www.berlinheart.com.

Contact:

Linda Buerk

Manager Marketing & PR

Phone: +49-30-8187-2650

Mobile: +49-173-629-0803

buerk@berlinheart.de


'/>"/>
SOURCE Berlin Heart AG
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. New Report by Pediatricians Finds Gaps in Preparing to Protect Kids From Pandemic Flu, Offers Recommendations
2. UPDATE: New Report by Pediatricians Finds Gaps in Preparing to Protect Kids From Pandemic Flu, Offers Recommendations
3. Large Controlled Trial of Widely Used Mood Stabilizers Demonstrates Efficacy in Pediatric Bipolar Disorder
4. MedImmune Presents New Pharmaco-Economic Data at American Academy of Pediatrics Regarding Infants at High Risk for RSV
5. Pediatric Pulmonary Expert Comments on Study of Lung Transplants for Cystic Fibrosis
6. Curemark Appoints Preeminent Pediatrics Gastroenterologist
7. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
8. MAP Pharmaceuticals Reports Positive Results From Comparative Pharmacokinetic Trial for its Pediatric Asthma Product Candidate
9. New Research for Mechanical Support Devices in Pediatrics to Be Released at International Heart and Lung Transplant Meeting
10. Phase 3 Data Regarding Anti-RSV Antibody To Be Presented at Pediatric Academic Societies (PAS) Annual Meeting
11. Anesiva Announces Publication of Phase 3 Zingo(TM) Data in the Journal Pediatrics
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/9/2017)... -- Dealmed Medical Supplies, New York City,s ... drugs, vaccines, and specialty medical products and services, announced ... acquire Vantage Medical Supplies, a major distributor of medical ... York . ... practices, will operate under the Dealmed name as of ...
(Date:9/7/2017)... , Sept. 7, 2017  For nearly two decades, New Life Agency ... Assisted Reproduction Insurance industry. Today, New Life Agency announces a powerful three-way ... ... ... http://pharmacarecard.com/ (PRNewsfoto/PharmaCareCard) ...
(Date:9/7/2017)... 7, 2017  Zimmer Biomet Holdings, Inc. (NYSE and ... announced that it will be participating in the Morgan ... the Grand Hyatt hotel in New York.  Zimmer Biomet ... a.m. Eastern Time. A live webcast of ... Relations website at http://investor.zimmerbiomet.com .   ...
Breaking Medicine Technology:
(Date:9/22/2017)... ... ... “Cursed with a Curse: The Truth about Tithing”: a ... when breaking free from this misconception. “Cursed with a Curse: The Truth about ... Christian Faith Publishing, Lysa M. Harrison’s new book is a powerful and thought-provoking ...
(Date:9/22/2017)... ... ... “Fruit of the Spirit: “Love””: a delightful adventure of two friends who ... the Spirit: “Love”” is the creation of published author, Halimah Jones, who was born ... is an avid writer, her inspiration for “Fruit of the Spirit: “Love”” blossomed from ...
(Date:9/21/2017)... ... September 21, 2017 , ... With ProSlideshow Portrait from ... easy to do. Users can select from up to two layers of subject matter ... of a mouse all within Final Cut Pro X. , With ProSlideshow ...
(Date:9/21/2017)... (PRWEB) , ... September 21, 2017 , ... ... **An FDAnews Management Report**, http://www.fdanews.com/products/54818-promotional-communication      , In the competitive world of ... can get while staying in compliance with FDA rules. , The FDA has ...
(Date:9/21/2017)... ... September 21, 2017 , ... Innovatum ... at the Global GS1 Healthcare Conference 2017 in Chicago, IL on October 17-19, ... ensuring label quality and improving patient safety. , Microscan , a ...
Breaking Medicine News(10 mins):