Navigation Links
Major Milestone Achieved - Berlin Heart EXCOR Pediatric IDE Study

THE WOODLANDS, Texas, September 1 /PRNewswire/ -- Berlin Heart Inc. reported today that it has completed enrollment in Cohort 1 of the Berlin Heart EXCOR(R) Pediatric IDE Study after having received unconditional approval of the study from the FDA in November 2008.

The Principal Investigator, Dr. Charles Fraser, Chief of Congenital Heart Surgery at Texas Children's Hospital and Professor of Surgery and Pediatrics at Baylor College of Medicine said, "We are very pleased with the progress of this study. Reaching this extremely important milestone brings us a step closer to understanding the potential of the EXCOR device as a reliable option for children with no hope who are dying from heart failure."

The last two patients implanted in this Cohort were implanted at Texas Children's Hospital in Houston, Texas by Dr. David Morales and at Children's Hospital of Wisconsin in Milwaukee, Wisconsin by Dr. James Tweddell.

Dr. Johannes Mueller, CEO of Berlin Heart commented, "Berlin Heart is proud that the EXCOR device is the first ventricular assist device to be involved in a prospective clinical trial involving the pediatric population. We are very pleased with the early clinical results of the study and are excited as this milestone brings us closer to our goal of making this device more readily available for sick children in the US."

Bob Kroslowitz, Vice President of Clinical Affairs for Berlin Heart said, "This is an outstanding achievement for the whole team. We especially thank our study sites, our investigators and most importantly, the families of the children that have been enrolled in the study. We look forward to compiling the results and submitting an application to the FDA for approval for this important group of patients while we continue to enroll additional pediatric patients into Cohort 2 of the study."

Implants of the EXCOR Pediatric device for Cohort 1 patients are continuing under a Continued Access Protocol that was recently approved by the FDA.

About EXCOR Pediatric

The EXCOR Pediatric ventricular assist device is a pulsatile, pneumatically driven cardiac support system for critically ill pediatric patients suffering from severe heart failure. It has been used in more than 600 pediatric patients worldwide ranging from newborns with 2.2 kg body weight to teenagers. EXCOR Pediatric is currently under clinical investigation for pediatric patients in USA.

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 is market leader in Germany and 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 six years. INCOR is not FDA approved, but widely used in Europe.


    Linda Buerk
    Manager Marketing & PR
    Phone: +49(0)30-8187-2650
    Mobile: +49(0)173-629-0803

SOURCE Berlin Heart GmbH
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Dow AgroSciences and Exelixis Plant Sciences Announce Major Research Collaboration, Asset Purchase to Advance Gene Discovery and Validation
2. Weil Gotshal Wins Major Victory for Applera; Secures Summary Judgment Invalidating Three Patents
3. Radius Grants Major Pharmaceutical Company Exclusive Option to License BA058 for Osteoporosis
4. Genzyme Begins Major Expansion of Boston Manufacturing Facility
5. International Atomic Energy Agency and National Foundation for Cancer Research Launch Major Initiative to Improve Cancer Prevention and Treatments in Developing Countries
6. Forest Laboratories Lexapro and Generics-Dominated Fluoxetine Lead First-Line Therapy in the Treatment for Major Depression
7. Updated Drug Development Scrip Report Responds to the Pharma Industrys Major Changes
8. National Surgical Hospitals Acquires Majority Share of Houston-Area Surgery Center
9. Agendia Acquires Rights to the Discovery of a Major Drug Resistance Mechanism in Breast Cancer Potentially Leading to a Herceptin(R) Sensitivity Test
10. Bioponic Phytoceuticals to Roll Out Multiple Products to 1,000 Major Health Food Stores in the Western United States
11. SPO Medical Announces Major Sales Milestone
Post Your Comments:
(Date:11/25/2015)... --> ... 2020 report analyzes that automating biobanking workflow will ... long-term samples, minimizing manual errors, improving the workflow ... errors such as mislabeling or inaccurate sample barcoding ... a vital role in blood fractionation, DNA extraction, ...
(Date:11/25/2015)... , Nov. 25, 2015  Neurocrine Biosciences, Inc. (Nasdaq: ... , President and CEO of Neurocrine Biosciences, will be ... in New York . ... the website approximately 5 minutes prior to the presentation ... of the presentation will be available on the website ...
(Date:11/25/2015)... ... 25, 2015 , ... Jessica Richman and Zachary Apte, founders ... initial angel funding process. Now, they are paying it forward to other microbiome ... investments in the microbiome space. In this, they join other successful entrepreneurs-turned-angels ...
(Date:11/24/2015)... Nov. 24, 2015 /CNW/ - iCo Therapeutics ("iCo" or ... financial results for the quarter ended September 30, ... Canadian dollars and presented under International Financial Reporting ... ," said Andrew Rae , President ... iCo-008 are not only value enriching for this ...
Breaking Biology Technology:
(Date:10/26/2015)...  Delta ID Inc., a company focused on bringing ... devices, announced its ActiveIRIS® technology powers the iris recognition ... by NTT DOCOMO, INC in Japan ... to include iris recognition technology, after a very successful ... May 2015, world,s first smartphone to have this capability. ...
(Date:10/23/2015)... and GOLETA, California , ... HFES conference, BIOPAC and SensoMotoric Instruments (SMI) announce a ... eye tracking data captured during interactive real-world tasks ... and play integration of their established wearable solutions for ... to synchronize gaze behavior captured with SMI Eye ...
(Date:10/22/2015)... SAN JOSE, Calif., Oct. 22, 2015  Synaptics (NASDAQ: SYNA ... results for its first quarter ended September 30, 2015. ... first quarter of fiscal 2016 grew 66 percent over the comparable ... quarter of fiscal 2016 was $23.8 million, or $0.62 per diluted ... net income for the first quarter of fiscal 2016 grew 39 ...
Breaking Biology News(10 mins):