Navigation Links
Berlin Heart Enrolls First Patient in US Multi-Center EXCOR(R) Pediatric VAD IDE Study
Date:11/30/2007

BERLIN, November 30 /PRNewswire/ -- Berlin Heart today announced the first patient enrolment in the prospective IDE study for its EXCOR(R) Paediatric VAD, a mechanical cardiac support system for critically ill Paediatric patients suffering from severe heart failure.

The multi-center IDE study is to evaluate the safety and probable benefit of using the EXCOR(R) Paediatric VAD to support Paediatric patients. The U.S. Food and Drug Administration granted conditional approval for the prospective IDE study to begin initially at 10 centers with 10 patients in May 2007.

The first patient in the study is an 8-year-old boy suffering from a congenital heart defect. The patient needed a biventricular assist device to support his weakened heart until a donor heart becomes available. The child had been transported from Texas to Arkansas Children's Hospital on an ECMO system (extra-corporeal membrane oxygenation) for the procedure.

On 27 November 2007 Dr. Michiaki Imamura, M.D., Ph.D., carried out the surgery that is reported to have gone well and without complications according to Dr. Robert Jaquiss, the Principal Investigator for the IDE study at Arkansas Children's Hospital. The patient is stable and currently in the ICU. Arkansas Children's Hospital has so far treated 13 patients with EXCOR(R) Paediatric, twelve of them under the compassionate use regulations.

Dr. Jaquiss commented: "We are very pleased the first EXCOR(R) Paediatric patient has been enrolled into the IDE study at our center. There is a great deal of interest in the medical community that this study proceeds quickly."

EXCOR(R) Paediatric has been designed as a bridge to transplantation for patients waiting for a suitable donor heart, but has also been used as a bridge to recovery when a patient's heart was able to recover and work on its own again. Unlike standard heart-lung machines, EXCOR(R) Paediatric has been used as a medium- to long-term support system, supporting failing hearts for up to several months.

Dr. Charles Fraser, M.D., the National Principal Investigator for the IDE study, congratulated the team at Arkansas Children's Hospital for proceeding with the first implant of the Berlin Heart EXCOR Paediatric VAD as part of the IDE study: "The initiation of this study represents a giant step forward in the care of children with critical heart failure. Those of us involved in this project are excited about the prospect of improved therapies for children in desperate need."

Dr. Rolf Kaese, CEO at Berlin Heart, commented: "Enrolling the first patient in the EXCOR(R) Paediatric IDE study marks a milestone and brings us one step closer toward obtaining HDE approval. This device fills a real void as it provides cardiac assist to the smallest patients for whom no real alternative exists."

About EXCOR(R) Paediatric

EXCOR(R) Paediatric is a pulsatile, pneumatically driven ventricular assist device and can be used to support one or both ventricles. EXCOR(R) Paediatric has been used in a total of 343 Paediatric patients ranging from newborns with 2 kg to teenagers with 90 kg body weight. The system has been used 118 times in North-America; with the FDA granting permission on a compassionate use basis.

About Berlin Heart

Berlin Heart is the only company that is able to provide a mid- to long-term ventricular assist device in the United States for Paediatric 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. Berlin Heart's products INCOR(R), EXCOR(R) and EXCOR(R) Paediatric 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 under the FDA investigational study. Further product information is available from the company website: http://www.berlinheart.com.

Contact:

Linda Buerk,

Berlin Heart GmbH,

Phone: +49(0)30-8187-2650,

Cell: +49(0)173-629-0803,

Fax: +49(0)30-8187-22-2650,

buerk@berlinheart.de.


'/>"/>
SOURCE Berlin Heart AG
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Thoratec Announces HeartMate II(R) PMA Will be Reviewed by FDA Advisory Panel
2. ATS Medical Expands Open Pivot Heart Valve Offerings
3. Cardicas C-Port(R) Flex A Anastomosis System Allows Surgeons to Perform Revolutionary Closed-Chest Heart Bypass Surgeries
4. Signalifes Dr. Harmison Launches Award-Winning Ambulatory Heart Monitor
5. Cleveland Clinic-Led Research Uncovers New Mechanism That Heightens Risk of Heart Disease
6. New Licence for Cubicin(R) (daptomycin), the First in a Novel Class of Antibiotic, is Announced Today for the Treatment of Serious Bloodstream and Heart Infections Caused by the Most Problematic UK Organisms, Including MRSA
7. Panel to Discuss the Far-Ranging Effects and Consequences of Heart Disease, Which is the Leading Killer in Both Men and Women in the United States
8. Cheetah Medicals NICOM Non-Invasive Cardiac Output Monitor Featured in a Presentation at the Heart Failure Society of America (HFSA) Annual Meeting
9. New Study Shows Promise for Hydrogen Sulfide in Reducing Heart-Attack Damage, Ikaria Announces
10. Americas Heartland Launches Third Season Highlighting Contributions of American Farmers and Ranchers
11. CV Therapeutics Announces Presentations at American Heart Association Scientific Sessions 2007
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/26/2017)... ... April 26, 2017 , ... Looking for gift ideas ... events company, offers one-of-a-kind gifts, ranging from gourmet cooking experiences to Farmer’s Market ... guests leave inspired with new cooking tips and techniques, thanks to Chef Jodi ...
(Date:4/26/2017)... ... April 26, 2017 , ... Baltimore bio tech firm, PathSensors, ... screening solution at the National Postal Forum 2017 in Baltimore, Maryland, May 21st ... accurate, easy to use and low cost threat detection solution for government and ...
(Date:4/25/2017)... ... April 25, 2017 , ... As part of the Stago EdVantage Virtual ... testing for DIC in order to illuminate this clinical problem for people unfamiliar with ... patients resulting in a high degree of morbidity and mortality. DIC is a confusing ...
(Date:4/25/2017)... ... April 25, 2017 , ... ... & Rehabilitation, P.A. , proudly announced today that acclaimed physiatrist Matthew Terzella, MD, ... on May 15, 2017. , Dr. Terzella completed his residency in Physical Medicine ...
Breaking Biology Technology:
(Date:3/30/2017)... YORK , March 30, 2017 Trends, ... type (physiological and behavioral), by technology (fingerprint, AFIS, iris ... voice recognition, and others), by end use industry (government ... and immigration, financial and banking, and others), and by ... Europe , Asia Pacific , ...
(Date:3/24/2017)... , March 24, 2017 The Controller General of ... Mr. Abdulla Algeen have received the prestigious international IAIR Award ... Continue Reading ... ... and Deputy Controller Abdulla Algeen (small picture on the right) have received ...
(Date:3/22/2017)... , March 21, 2017   Neurotechnology ... object recognition technologies, today announced the release of ... (SDK), which provides improved facial recognition using up ... on a single computer. The new version uses ... improve accuracy, and it utilizes a Graphing Processing ...
Breaking Biology News(10 mins):