Navigation Links
Berlin Heart Inc. Receives FDA Orphan Product Development Grant
Date:6/17/2009

THE WOODLANDS, Texas, June 17 /PRNewswire/ -- Berlin Heart Inc. today announced it has been awarded an Orphan Product Development Grant by the FDA, to support the ongoing Investigational Device Exemption (IDE) study of the EXCOR(R) Pediatric Ventricular Assist Device (VAD). Dr. Christopher Almond of the Children's Hospital of Boston, and Bob Kroslowitz, Vice President of Clinical Affairs for Berlin Heart Inc. will serve as Co-Principal Investigators for the grant project "Safety and Efficacy of the Berlin Heart EXCOR Pediatric VAD as a Bridge to Heart Transplantation."

The Berlin Heart EXCOR Pediatric VAD is a system for mechanical support of the heart in end-stage heart failure patients. It has been specifically designed for use in pediatric patients of all age groups ranging from newborns to teenagers. The device received unconditional approval for investigational use in pediatric patients in the US in October 2008 and is currently undergoing an IDE trial.

The goal of the Office of Orphan Products Development Grant Program is to encourage clinical development of products for use in rare diseases or conditions. At this time, only clinical studies qualify for consideration. All studies must be conducted under an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE). The grant awarded to Berlin Heart provides three years of support.

The number of grant awards varies each year depending on the availability of funds. On-going studies are funded first with the remainder of funds going to new studies. In recent years, the Office of Orphan Products Development Grant Program has funded approximately twelve to fifteen new awards annually.

Johannes Mueller, M.D., the CEO of Berlin Heart comments, "We are very pleased we have been awarded this considerable grant for our ongoing EXCOR Pediatric IDE study. We see the awarded grant as a clear indicator for the importance of our product and for the potential it has to make a life-saving difference for pediatric patients."

About EXCOR(R) Pediatric

The EXCOR Pediatric Ventricular Assist Device is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. EXCOR Pediatric has been used in more than 500 pediatric patients worldwide ranging from newborns with 2.2 kg body weight to teenagers. EXCOR 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 (also called mechanical heart support systems) 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 five and a half years and ongoing. INCOR is not FDA approved, but widely used in Europe.

    Contact:
    Linda Buerk
    Manager Marketing & PR
    Phone: +49(0)30-8187-2650
    Mobile: +49(0)173-629-0803
    buerk@berlinheart.de



'/>"/>
SOURCE Berlin Heart GmbH
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. 500th Patient Receives Berlin Heart EXCOR Pediatric Ventricular Assist Device
2. DuoCort Hosts Adrenal Insufficiency Symposium at the 10th European Congress of Endocrinology in Berlin
3. Berlin Heart Enrolls First Patient in US Multi-Center EXCOR(R) Pediatric VAD IDE Study
4. PeriCor Therapeutics Reports Positive Preclinical Results of GP531 at the European Heart Failure Congress in Nice
5. Multiple Types of Heart Attacks Reduced by Prasugrel in TRITON-TIMI 38 Trial
6. Nile Therapeutics CD-NP Clinical Program for Acute Heart Failure Released From Clinical Hold by FDA
7. Boston Scientific to Donate Cardiac Rhythm Management Devices to Heartbeat International for Implantation in Needy Patients
8. Boston Scientific Announces Company Schedule for Heart Rhythm Society Scientific Sessions
9. deCODE and Celera Partner to Expand use of deCODE Risk Markers for Heart Attack, Stroke and Diabetes
10. Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for HeartMate II(R)
11. Symphony Medical Announces First Patient Successfully Treated With Novel Congestive Heart Failure Therapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... Md. , June 23, 2016 A person ... from the crime scene to track the criminal down. ... the U.S. Food and Drug Administration (FDA) uses DNA evidence ... Sound far-fetched? It,s not. The FDA ... sequencing to support investigations of foodborne illnesses. Put as simply ...
(Date:6/23/2016)... YORK , June, 23, 2016  The Biodesign ... to envision new ways to harness living systems and ... Modern Art (MoMA) in New York City ... than 130 participating students, showcased projects at MoMA,s Celeste ... Paola Antonelli , MoMA,s senior curator of architecture ...
(Date:6/23/2016)... ... 2016 , ... In a new case report published today in STEM CELLS ... developed lymphedema after being treated for breast cancer benefitted from an injection of stem ... with this debilitating, frequent side effect of cancer treatment. , Lymphedema refers ...
(Date:6/23/2016)... 23, 2016 On Wednesday, June 22, ... down 0.22%; the Dow Jones Industrial Average edged 0.27% lower ... 2,085.45, down 0.17%. Stock-Callers.com has initiated coverage on the following ... Therapeutics (NASDAQ: NKTR ), Aralez Pharmaceuticals Inc. (NASDAQ: ... BIND ). Learn more about these stocks by accessing ...
Breaking Biology Technology:
(Date:5/9/2016)... -- Elevay is currently known as the ... high net worth professionals seeking travel for work   ... there is still no substitute for a face-to-face meeting. ... deal with a firm handshake. This is why wealthy ... citizenship via investment programs like those offered by the ...
(Date:4/26/2016)... 27, 2016 Research and ... Biometrics Market 2016-2020"  report to their offering.  , ... The analysts forecast the global multimodal biometrics ... during the period 2016-2020.  Multimodal biometrics ... such as the healthcare, BFSI, transportation, automotive, and ...
(Date:4/13/2016)... 13, 2016  IMPOWER physicians supporting Medicaid patients in ... new clinical standard in telehealth thanks to a new ... higi platform, IMPOWER patients can routinely track key health ... mass index, and, when they opt in, share them ... to a local retail location at no cost. By ...
Breaking Biology News(10 mins):