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

160;Dr. Fraser and Dr. Canter were supported by Rebecca Ichord, M.D., Lori Jordan, M.D., James Tweddell, M.D., David Rosenthal, M.D.,  Robert Jaquiss, M.D., Peter Wearden, M.D., Elaine Cox, M.D., Patti Massicotte, M.D., Tilman Humpl, M.D., David Naftel, PhD., and Chris Almond, M.D. Supporting the Investigators and Advisors from Berlin Heart were Bob Kroslowitz, VP Clinical Affairs, Mary Beth Kepler, VP Regulatory Affairs and Quality Assurance, and Christine Tjossem Director of Statistical Operations.

The events of the day culminated in the public forum vote by the panel on the questions of EXCOR® device safety and probable benefit.  In a thrilling process, the panel members voted unanimously in favor of HDE approval.  The commentary from each panel member proved insightful and supportive.  This was an emotional and very gratifying experience for all of those in attendance.

Dr. Fraser commented, "This is an enormous step forward for children with heart failure.  I would like to personally thank all of the individuals who have been so supportive of this difficult and important study; people from across the United States, Canada and from Germany.  We have all worked together to establish a new precedent for our patients."

The following US centers participated in the IDE study:

  • Arkansas Children's Hospital (AR)
  • Boston Children's Hospital (MA)
  • Children's Healthcare of Atlanta (GA)
  • Children's Hospital of Wisconsin (WI)
  • The Children's Hospital of Denver (CO)
  • Lucille Packard Children's Hospital at Stanford (CA)
  • Mott Children's Hospital (MI)
  • Mount Sinai Hospital (NY)
  • Pittsburgh Children's Hospital (PA)
  • Riley Children's Hospital (IN)
  • Seattle Children's Hospital (WA)
  • St. Louis Children's Hospital (MO)
  • Texas
    '/>"/>

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

0

GOOD

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:5/17/2013)... a world-leading provider of scientific, technical and medical information ... recent study in Reproductive BioMedicine Online ... with an abnormal chromosomal composition can be identified by ... thereby classifying the risk of genetic abnormality without a ... undertaken a retrospective study, using their predictive model to ...
(Date:5/17/2013)... TRIANGLE PARK, N.C., USA (PRWEB) May 17, 2013 ...     Green Globes Certified for sustainability , ... and insect pressures , Syngenta ... opening celebration today at the company’s RTP Innovation Center. ... Lab allows company researchers to simulate any agricultural climate ...
(Date:5/17/2013)... May 17, 2013  Cellular Biomedicine Group (OTCQB: ... enrollment of the total projected enrollment required for ... and preliminary efficacy of the medical technology haMPC ... Osteoarthritis (KOA). To date the trial has had ... The Phase I open label clinical research trial ...
(Date:5/17/2013)... 2013 /PRNewswire-iReach/ -- Aridis is pleased to announce ... Switzerland -based Kenta Biotech to acquire ... (mAb) products, and technologies. This asset portfolio purchase ... of infections by common pathogens including drug resistant ... Pseudomonas aeruginosa , Acinetobacter baumannii and ...
Breaking Biology Technology:Breakthrough for IVF? 2Breakthrough for IVF? 3Syngenta Opens Unique $72 Million Advanced Crop Lab 2Syngenta Opens Unique $72 Million Advanced Crop Lab 3Cellular Biomedicine Group Achieves 50% Enrollment Milestone in Phase I Clinical Trial for Knee Osteoarthritis 2Aridis Pharmaceuticals Announces Acquisition of Monoclonal Antibody Products and Technologies From Kenta Biotech 2Aridis Pharmaceuticals Announces Acquisition of Monoclonal Antibody Products and Technologies From Kenta Biotech 3
... effectDENVER, March 18 Corgenix Medical Corporation (OTC ... of diagnostic test kits, has announced it will ... 31 at the American College of Cardiology (ACC) ... take place in Orlando, Fla., at the Orange ...
... Despite the initial regulatory hiccups, the number of ... increase gradually. The patent expiry of key biopharmaceuticals ... driving the development of biosimilars. In addition, payers, ... drugs due to their safety, efficacy and affordability, ...
... March 18 , ... Education,Communication and Compliance Challenges of Radiologic Technologists, Managers ... introduced Mosby,s Imaging Suite,( http://www.mosbysimagingsuite.com ), the first ... research, education, communication and,compliance challenges of radiologic technologists ...
Cached Biology Technology:Corgenix to Exhibit AspirinWorks(R) Test at ACC.09 2Corgenix to Exhibit AspirinWorks(R) Test at ACC.09 3The Need for Safe and Affordable Biopharmaceuticals Drives the Development of the European Biosimilars Market, Says Frost & Sullivan 2The Need for Safe and Affordable Biopharmaceuticals Drives the Development of the European Biosimilars Market, Says Frost & Sullivan 3The Need for Safe and Affordable Biopharmaceuticals Drives the Development of the European Biosimilars Market, Says Frost & Sullivan 4New Online Imaging Suite Boosts Healthcare Imaging Efficiency, Productivity, and Revenues 2New Online Imaging Suite Boosts Healthcare Imaging Efficiency, Productivity, and Revenues 3New Online Imaging Suite Boosts Healthcare Imaging Efficiency, Productivity, and Revenues 4
(Date:5/17/2013)... Bethesda, MD (May 18, 2013) The AGA Research ... research into the relationship between the gut microbiota, one ... health and disease. , The AGA Research Awards ... colleagues from Massachusetts General Hospital and Harvard Medical School, ... Award recipient. Dr. Chan will receive $25,000 of funding, ...
(Date:5/17/2013)... Shenzhen, China---- Why Tibetan antelope can live at ... a collaborative research published in Nature Communications ... institutes provide evidence that some genetic factors may ... highland environments. The data in this work will ... and the biology of other ruminant species. , ...
(Date:5/16/2013)... 17, 2013) Illustrating a commitment to the ... Gastroenterological Association (AGA) Research Foundation has announced the ... Fellowship Award recipients. Supported by the National Institute ... this new award helps underrepresented minority students to ... nutrition research. , "By establishing this new award, ...
Breaking Biology News(10 mins):New gut microbiome research to explore red meat -- colorectal cancer pathway 2The genome sequence of Tibetan antelope sheds new light on high-altitude adaptation 2Underrepresented minority students receive fellowships in digestive disease and nutrition research 2
... two most important recreational fisheries off Southern California ... by a researcher from Scripps Institution of Oceanography ... Brad Erisman and his colleagues examined the health ... kelp bass-staple catches of Southern California,s recreational fishing ...
... Steve Bergens and his graduate student Jeremy Johns ... to revolutionise the chemical industry by reducing its ... Their findings were published in a top international ... the chemical industry with a potential solution to ...
... -- The National Institutes of Health (NIH) has awarded a ... research into risk factors for spina bifida and related congenital ... or brain is not fully enclosed. The research will ... E. Mason at Weill Cornell Medical College. Dr. Ross is ...
Cached Biology News:'Illusion of plenty' masking collapse of 2 key Southern California fisheries 2Catalyst discovery has potential to revolutionize chemical industry 2NIH awards $5.5 million grant to Weill Cornell for research into preventing spina bifida 2NIH awards $5.5 million grant to Weill Cornell for research into preventing spina bifida 3
sodium channel, nonvoltage-gated 1 alpha,...
4-Hydroxy-3-nitrophenylacetyl hapten is conjugated to SGG (Sheep gamma globulin) lysine through amide bonds. This product is homologous to NP-BSA....
MOUSE ANTI HUMAN B-CELLS (FMC7):FITC Immunogen: HRIK cells - Human B-Lymphoblastoid line...
... ideal for use in refrigerators, freezers, or liquid nitrogen. ... colors allow for color coding to project, user, lab, ... or promote cool air circulation. Supplied with 9 x ... Box dimensions: 13 x 13 x 5.1 ...
Biology Products: