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 t
'/>"/>

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

1

GOOD

Page: 1 2

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:11/19/2009)...would like to be able to charge their cell phones ... often. A recent discovery made by UC San Diego en...apacitors that could do just this. , In recent ...Prabhakar Bandaru, a professor in the UCSD Departm... with graduate student Mark Hoefer, have found tha...
(Date:11/19/2009)...ORK, Nov. 19 NeoStem, In... sent the following letter to its shareholders, di... 2009, of China Biopharmaceuticals Holdings, Inc. ...ased in the People,s Republic of China. The merger...u Eyre Pharmaceutical Co. Ltd., CHBP,s primary ope...
(Date:11/19/2009)... Top LASIK surgeons and recognized refrac...d LASIK Surgeons made brought their fellow surgeon...correction surgery, cataract surgery, and ophthalm...n Academy of Ophthalmology (AAO) annual meeting in... Dr. Shachar Tauber, Dr. David Huang, MD, Dr. Rand...
(Date:11/18/2009)...he National Institute of Standards and Technology ...ensive method for detecting and measuring elusive ...nvisible spoilage in food or pesticides distribute...s more sensitive than conventional techniques for ...arlike water molecules, having distinct electrical...
Breaking Biology Technology:Nanotube defects equal better energy and storage systems 2NeoStem Outlines to Shareholders Near-term and Long-term Business Strategies Following Acquisition of Chinese Pharmaceutical Company 2NeoStem Outlines to Shareholders Near-term and Long-term Business Strategies Following Acquisition of Chinese Pharmaceutical Company 3Experts Listed at Trusted LASIK Surgeons Bring Peers Up to Date on Vision Correction and Cataract Surgery at Annual AAO Meeting 2Experts Listed at Trusted LASIK Surgeons Bring Peers Up to Date on Vision Correction and Cataract Surgery at Annual AAO Meeting 3Experts Listed at Trusted LASIK Surgeons Bring Peers Up to Date on Vision Correction and Cataract Surgery at Annual AAO Meeting 4Experts Listed at Trusted LASIK Surgeons Bring Peers Up to Date on Vision Correction and Cataract Surgery at Annual AAO Meeting 5Experts Listed at Trusted LASIK Surgeons Bring Peers Up to Date on Vision Correction and Cataract Surgery at Annual AAO Meeting 6Experts Listed at Trusted LASIK Surgeons Bring Peers Up to Date on Vision Correction and Cataract Surgery at Annual AAO Meeting 7Experts Listed at Trusted LASIK Surgeons Bring Peers Up to Date on Vision Correction and Cataract Surgery at Annual AAO Meeting 8Experts Listed at Trusted LASIK Surgeons Bring Peers Up to Date on Vision Correction and Cataract Surgery at Annual AAO Meeting 9Prototype NIST method detects and measures elusive hazards 2
..., March 2 American Pacific Corporation (Nasdaq: ...ed subsidiary AMPAC Fine Chemicals LLC (AFC) recei...Award from the Department of Toxic Substances Cont... Council of California (CICC). The award recognize... AFC,s STRIDE (Sustainability Through Renewable In...
..., Pa., March 2 Morphotek(R), Inc., a subsidiary o...ced that it has commenced a,multi-centered Phase I...sothelioma. The study will evaluate MORAb-009, plu...m, as a first-line treatment for patients with,mes...y is to assess the efficacy of MORAb-009,as combin...
..., March 2 /PRNewswire-FirstCall/ - Angiotech Pharm... announced it has obtained a new Senior Secured Te... Foothill, LLC is the sole arranger, administrativ...lving Credit Facility. , The financing includes a ...10 million, and a secured revolving credit facilit...
Other Biology Technology:AMPAC Fine Chemicals Receives the California Pollution Prevention Challenge Award Two Consecutive Years 2AMPAC Fine Chemicals Receives the California Pollution Prevention Challenge Award Two Consecutive Years 3Morphotek(R), Inc. Announces Initiation of MORAb-009 Phase II Study in First- Line Treatment of Mesothelioma 2Morphotek(R), Inc. Announces Initiation of MORAb-009 Phase II Study in First- Line Treatment of Mesothelioma 3Angiotech Pharmaceuticals, Inc. announces new Senior Secured Term Loan and Credit Facilities 2Angiotech Pharmaceuticals, Inc. announces new Senior Secured Term Loan and Credit Facilities 3Angiotech Pharmaceuticals, Inc. announces new Senior Secured Term Loan and Credit Facilities 4
(Date:11/19/2009)... Leaf-cutter ants, which cultivate fungus for foo...ew one to add to the list: the ant farmers, like t... bacteria to make their gardens grow. The finding,...nce , documents a previously unknown symbiosis bet...ow leaf-cutter ants have come to dominate the Amer...
(Date:11/19/2009)...s an important crop in many countries of the world...feed, and industrial materials. It also is conside...cation, molecular evolution, and genome architectu...special collection used the first description of t...iguing questions in genetics and plant biology. Th...
(Date:11/19/2009)... Spring Harbor, NY A four-year, multi-institution...atory (CSHL) scientists culminated today in public...l Science revealing in unprecedented detail the ..., as it is commonly called by North American consu...and the most valuable agricultural crop grown in t...
Breaking Biology News(10 mins):Like humans, ants use bacteria to make their gardens grow 2PLoS Genetics 2009 maize genome collection 2PLoS Genetics 2009 maize genome collection 3PLoS Genetics 2009 maize genome collection 4Reference genome of maize, most important US crop, is published by team co-led by CSHL scientists 2Reference genome of maize, most important US crop, is published by team co-led by CSHL scientists 3Reference genome of maize, most important US crop, is published by team co-led by CSHL scientists 4Tianyin Pharmaceutical Co to Present at the Rodman 26 Renshaw Annual Global Investment Conference on September 11 at 10 3A50 am ET 13735 1Tianyin Pharmaceutical Co to Present at the Rodman 26 Renshaw Annual Global Investment Conference on September 11 at 10 3A50 am ET 13735 2Tianyin Pharmaceutical Co to Present at the Rodman 26 Renshaw Annual Global Investment Conference on September 11 at 10 3A50 am ET 13735 3HOYA ConBio Announces Educational Alliance with LVI Global Australia 55683 1HOYA ConBio Announces Educational Alliance with LVI Global Australia 55683 2Sundia Receives the Highest Growth Potential Award from Zhangjiang 55681 1Sundia Receives the Highest Growth Potential Award from Zhangjiang 55681 2
...may have found why women have an edge in keeping a... eat and excrete - at least before reaching menopa...r problems with salt-sensitive hypertension and hy...re essentially the same as men, says Dr. David Pol...enter at the Medical College of Georgia. , The re...
...9) Virginia Commonwealth University researchers h...in regulating mitochondria, the energy-producing m...d to the development of new treatments for heart d...to master the abnormal metabolism of cancer. , In...xpress, researchers reported that Stat3, a protein...
.... It occurs when changes take place in the genes t...h, cell signalling and blood vessel formation eit...ch as smoking or radiation or due to inherited ch...d environmental factors means that cancer is an ex...endometrial carcinoma, is no exception. , Cancer ...
Other Biology News:Researchers may have found why women have an edge on salt-sensitive hypertension 2New research findings may enable earlier diagnosis of uterine cancer 2
...teinChip arrays have been developed for affinity c...ety of ProteinChip chemical surfaces allow differe...e biochemical properties. Each chip has eight diff...on, and the chips are color-coded with a unique hy...
SmartSpec Printer Paper, 5 pack from Bio-Rad
...teinChip arrays have been developed for affinity c...ety of ProteinChip chemical surfaces allow differe...e biochemical properties. Each chip has eight diff...on, and the chips are color-coded with a unique hy...
...ssay with SR-101 Labeled Substrates (red fluoresce...re serine protease activation • No lysing, fi...Kits utilize cell-permeable, fluorescently labeled...e chymotrypsin-like activity in whole living cells...
Biology Products: