Navigation Links
FDA Advisory Panel Unanimously Recommends Approval of EXCOR(R) Pediatric Ventricular Assist Device for Use in the United States
Date:7/26/2011

BERLIN and THE WOODLANDS, Texas, July 26, 2011 /PRNewswire/ --

 

At the request of Dr. Bram Zuckerman, Director, Division of Cardiovascular Devices, Center for Devices and Radiologic Health of the United States Food and Drug Administration, a special panel was convened on Thursday July 21 in Gaithersburg, Maryland to review the results of the EXCOR® IDE clinical trial.  The specific charge of the panel was to review the clinical data from the trial and to make recommendations to the FDA concerning the safety and probable benefit of the EXCOR® VAD as it pertains to an application for Humanitarian Device Exemption (HDE) approval. This 22 member panel was comprised of a group of experts in pediatric and adult cardiology, pediatric and adult cardiac surgery, neurology, biostatistics, and other areas of expertise.  It also included patient, consumer, and industry representatives. The panel was chaired by Dr. Clyde Yancy, Chief of the Division of Cardiology at Northwestern University School of Medicine in Chicago, Illinois.  

In preparation for presenting the study results to the panel, a team representing Berlin Heart and the investigation was assembled.  Working together over several months, including several face to face meetings, this group, now affectionately termed the Berlin Heart "Dream Team", worked very hard to be well prepared. The main presentation and the bulk of the clinical data and trail results was presented to the Panel by the National Principal Investigator of the study, Charles D. Fraser, Jr., M.D., FACS, Surgeon-in-Chief, Clayton Chair in Surgery, Donovan Chair and Chief, Congenital Heart Surgery, Texas Children's Hospital and Professor of Surgery and Pediatrics, Baylor College of Medicine and Charles E. Canter, M.D. Medical Director, Heart Failure/Transplant Program / St. Louis Children's Hospital, and Professor of Pediatrics, Washington University School of Medicine. &#
'/>"/>

SOURCE Berlin Heart GmbH
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Laszlo Radvanyi, Ph.D. Joins Genesis Biopharma Scientific and Medical Advisory Board
2. Oramed Pharmaceuticals Appoints Dr. Michael Berelowitz as Chairman of Scientific Advisory Board
3. GeneLink Biosciences Expands its Scientific Advisory Board to Support New Product Lines
4. Biomatrica Announces the Appointment of Dr. James A. Robb as a Member of the Scientific Advisory Board
5. Patrick Hwu, M.D., and Mario Sznol, M.D., Join Genesis Biopharmas Scientific and Medical Advisory Board
6. Governor Gray Davis Joins Genesis Biopharma as Chairman of Corporate Advisory Board
7. FDA Advisory Committee Recommends US Approval of Novartis Once-daily Bronchodilator QAB149 for COPD
8. Myriant Technologies, Inc. Announces J. Brian Ferguson to Join Advisory Board
9. Sensus Healthcare Announces the Formation of a Medical Advisory Board
10. Max Neeman International Initiates Advisory Committee to Advance and Improve the Conduct of Complex Neurological Trials in India
11. Leading Dental Stem Cell and Regenerative Medicine Researcher Dr. George Huang Joins StemSaves Science Advisory Council
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/17/2014)... , 17 de septiembre de 2014 /PRNewswire/ ... principal proveedor mundial de soluciones logísticas avanzadas ... de la vida, anunció hoy la contratación ... global con sede en Rótterdam, Países Bajos, ... clientes Europa en rápido crecimiento. Según los ...
(Date:9/17/2014)... 2014 First antibacterial ... a truly novel class of anti-infective in ... a biopharmaceutical company developing a truly novel ... has secured £4.0m ($6.4m) to advance the ... a range of Gram-positive infections including  Clostridium ...
(Date:9/17/2014)... The Alliance for Clinical ... non-profit collaborative building a global system to enhance ... announced Phase 3 of its Site Accreditation and ... H. Kalali, Vice-President, Global Head, Neuroscience Center of ... and Quality Integration (CQI) Consulting will lead the ...
(Date:9/16/2014)... energy from jaw movements has been created by a ... that the device can generate electricity from eating, chewing ... or wearable electronic devices, such as hearing aids, cochlear ... first results of the device,s performance have been published ... Materials and Structures . , Jaw movements have proved ...
Breaking Biology Technology:Cryoport contrata a Broekman Group para mejorar su apoyo operativo y logístico en Europa 2Cryoport contrata a Broekman Group para mejorar su apoyo operativo y logístico en Europa 3Cryoport contrata a Broekman Group para mejorar su apoyo operativo y logístico en Europa 4Cryoport contrata a Broekman Group para mejorar su apoyo operativo y logístico en Europa 5MGB Biopharma Secures £4.0m ($6.4m) to Advance its Novel Lead Antibacterial, MGB-BP-3, into Clinical Development 2MGB Biopharma Secures £4.0m ($6.4m) to Advance its Novel Lead Antibacterial, MGB-BP-3, into Clinical Development 3MGB Biopharma Secures £4.0m ($6.4m) to Advance its Novel Lead Antibacterial, MGB-BP-3, into Clinical Development 4MGB Biopharma Secures £4.0m ($6.4m) to Advance its Novel Lead Antibacterial, MGB-BP-3, into Clinical Development 5MGB Biopharma Secures £4.0m ($6.4m) to Advance its Novel Lead Antibacterial, MGB-BP-3, into Clinical Development 6MGB Biopharma Secures £4.0m ($6.4m) to Advance its Novel Lead Antibacterial, MGB-BP-3, into Clinical Development 7Global Standards Initiative for Clinical Research Sites Advances 2Global Standards Initiative for Clinical Research Sites Advances 3Global Standards Initiative for Clinical Research Sites Advances 4'Smart material' chin strap harvests energy from chewing 2
... MO BIO Laboratories, Inc., a leader in nucleic ... of an innovative new product for gel electrophoresis, Dye ... time-consuming step in the gel loading process, remove the ... tip waste. (Photo: http://photos.prnewswire.com/prnh/20110223/LA52919 ) ...
... announces that a new market research report is ... Biotechnology Reagents Industry http://www.reportlinker.com/p098414/Global-Biotechnology-Reagents-Industry.html ... worldwide markets for Biotechnology Reagents in US$ Million ... DNA Sequencing/Synthesis Reagents, Electrophoresis Reagents, Flow Cytometry Reagents, ...
... 23, 2011 Ingenuity® Systems, a leading provider ... researchers, today announced a research collaboration with Covance ... (NGS) data analysis. Covance Genomics Laboratory, a leading ... and development industry, and Ingenuity will work together ...
Cached Biology Technology:MO BIO Laboratories, Inc. Launches Dye Dots™ Dry Gel Loading Dye 2Reportlinker Adds Global Biotechnology Reagents Industry 2Ingenuity Systems and Covance Collaborate to Support Next-Generation Sequencing Research 2
(Date:9/17/2014)... on a Carnegie expedition in Australia,s Great Barrier Reef ... since the mid-1970s. The scientists suggest that ocean acidification ... slowdown. , In a quest for historical context ... current measurements of the growth rate of a section ... more than 30 years ago. Their work is published ...
(Date:9/17/2014)... MSSA could be curbed by coating hospital surfaces ... of shark skin, according to research published in ... Infection Control . , The study modelled how ... disease bacteria through touching, sneezes or spillages. The ... formulated to resemble shark skin. The study showed ...
(Date:9/16/2014)... "molecular brakes" that time the generation of important cells ... cells" translate sound waves into electrical signals that are ... If the arrangement of the cells is disordered, hearing ... will be published in The Journal of Neuroscience ... Hey2 act as brakes to prevent hair cell generation ...
Breaking Biology News(10 mins):Coral growth rate plummets in 30-year comparison 2Sharks' skin has teeth in the fight against hospital superbugs 2Hey1 and Hey2 ensure inner ear 'hair cells' are made at the right time, in the right place 2
... in the field of life in extreme environments research ... offices in Cambridge (UK) to officially kick off the ... in Extreme Environments). , Life in Extreme Environments is ... considerable expertise but a relatively fragmented research infrastructure. The ...
... Care Congress is the premier forum for health care ... to network with key leaders. The 2008 Congress will ... largest employers, hospitals, health systems, health plans, pharmaceutical and ... many highlights, the Presidential Health Care Agenda, will feature ...
... Coral reefs could be dying out because of changes to ... from the direct rise in temperature caused by global warming, ... the Society for General Microbiologys 162nd meeting being held this ... are currently balanced on a climate change knife edge. Corals ...
Cached Biology News:5th Annual World Health Care Congress April 21-23, Washington, D.C. 2Coral reefs and climate change: Microbes could be the key to coral death 2Coral reefs and climate change: Microbes could be the key to coral death 3
... Sets Sets of pET host strains ... The most common method for transformation of ... to use chemically competent cells. Although competent ... greater efficiency, reproducibility and convenience are achieved ...
... uses a simplified procedure and streamlines the ... kit is based on the three step ... sodium bisulfite where cytosine is converted into ... in-column desulphonation reaction eliminates several precipitation steps ...
... x-ray detectors from KUBTEC represents a stand-alone, ... to 16 bit digital interface. The large ... sensor with pixel spacing down to 48 ... x-ray energies (10-50 kV) and an extended ...
... kit was tested on rat tissue extracts (liver, ... ( S. cerevisae ) extract. It was also ... and cell lines. Application: A simple and reliable ... based on the detection of the inorganic phosphate ...
Biology Products: