Navigation Links
Texas Children's Hospital, Lead Study Center, Announces U.S. Food and Drug Administration Approval of EXCOR® Pediatric Ventricular Assist Device for Use in United States
Date:12/16/2011

ter implanted its first Berlin Heart on Sept. 27, 2005 in one of the smallest babies to ever receive the device. Brady Burch, a Corpus Christi resident, is now 6 years old and in kindergarten.  Fraser, who has long advocated that babies need small heart assist devices sized just for them, became proactively involved. He accompanied Berlin Heart representatives to Washington, requesting that the FDA allow an IDE study. The FDA agreed to open a study. The first pediatric patient was enrolled in November 2007.

Study background

In January 2008, Texas Children's was named the national lead center for a 12-hospital, 36-month clinical trial of the Berlin Heart EXCOR Pediatric VAD. Fraser was selected as the National Principal Investigator (NPI) for the IDE prospective study. In 2009, five other hospitals were added to the study.

The EXCOR® pediatric clinical study is the first prospective clinical trial ever conducted to investigate the safety and benefit of a VAD in the pediatric population. Between 2007 and 2010, the study enrolled 48 patients in two cohorts of 24 patients each. Another 200 patients were enrolled in a "compassionate use" cohort.  Along with Texas Children's Hospital, the following U.S. 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), Children's Hospital at the University of Alabama at Birmingham (AL), and the University of Minnesota at Fairview (MN).

As NPI, Fraser worked in cooperation with all 17 hospitals in collecting and reporting data to the FDA regarding the safety and prob
'/>"/>

SOURCE Texas Children's Hospital
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Texas to Modernize Medicaid Rx Benefits, Curb Pharmacy Overpayments
2. Heart Hospital of Austin Physician First in Texas to Implant New Heart Failure Device
3. A Heart for Jordan Merecka: Texas Childrens Hospitals First Total Artificial Heart Patient Receives the Gift of a Donor Heart
4. Research Demonstrates Possible Texas Job Losses from Sectors Supported by Biopharmaceutical Companies
5. Vista Imaging Services, Inc. Supplies New C-Arm Inventory and Highly Qualified Professional Radiology Technologists to the Texas Institute for Medical Education (TIME) and Medical Education & Research Institute of Nevada (MERIN)
6. PCAN Calls On Federal Government to Reconsider Preliminary Approval of Texas Medicaid Waiver Request
7. MedInformatix Practice Management and Electronic Medical Records Simplifies Texas Dermatology Practices Current and Future Operations
8. Texas Childrens Hospital Explants Heart Assist Device: Sends Teen Home with a Healed Heart
9. Texas Childrens Hospital Pioneers Use of MRI-guided Laser Surgery for Revolutionary New Epilepsy Treatment
10. American Scientific Resources and School Health Corporation to Supply The Disintegrator™ Needle Destruction Device to Texas School District
11. Pharmacy Choice and Access Now Coalition Applauds Passage of Senate Bill 7 During Texas Legislatures Special Session
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... -- According to Millennium Research Group (MRG), the global ... the United States and European transcatheter ... moderately through 2022, with embolization particles representing one ... in drug-eluting beads (DEBs) and radioembolization spheres in ... markets. The European radioembolization sphere market ...
(Date:1/15/2014)... -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX ... under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 ("HSR") ... its indirect wholly-owned subsidiary, Sapphire Subsidiary Corp. ("Purchaser"), for ... Solta Medical, Inc. (NASDAQ: SLTM ) ("Solta") ... the seller in cash, without interest (less any required ...
(Date:1/15/2014)... CAMBRIDGE, Mass. , Jan. 15, 2014 /PRNewswire/ ... addressing the unmet needs of severely obese patients, ... study of beloranib, a selective inhibitor of methionine ... (PWS), a severe form of genetic obesity.  These ... and body composition, including reductions in body fat ...
Breaking Medicine Technology:US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 2US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 3Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 2Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 4
... A Duke University pioneer in personalized medicine at ... National Conference said physicians must lead the way in ... preventive care. , Dr. Ralph Snyderman, director of the ... that personalized medicine based on genetic and other individual ...
... N.J., Oct. 1 Bayer HealthCare Pharmaceuticals, Inc., ... Administration (FDA) approved a new indication for Mirena® ... menstrual bleeding in women who choose to use ... Mirena provides an effective, non-surgical option for the ...
Cached Medicine Technology:Personalized Medicine Expert: Don't 'Fix It,' 'Predict It' 2FDA Approves New Indication For Mirena(R) to Treat Heavy Menstrual Bleeding in IUD Users 2FDA Approves New Indication For Mirena(R) to Treat Heavy Menstrual Bleeding in IUD Users 3FDA Approves New Indication For Mirena(R) to Treat Heavy Menstrual Bleeding in IUD Users 4
(Date:4/14/2014)... orphaned by HIV/AIDS in South Africa may provide insight ... behavior issues in other areas of the world, which ... that could lead to successful interventions. , A ... United Nations mentions that due to the HIV/AIDS pandemic, ... African, children are at an increased risk for mental ...
(Date:4/14/2014)... A new study shows that moderate to severe ... risk of stroke, cancer and death. , Results of ... to severe obstructive sleep apnea were four times more ... times more likely to have a stroke (HR = ... (HR = 3.4), and 2.5 times more likely to ...
(Date:4/14/2014)... Dallas study involving serious youth offenders, the answer to one ... seven years: "How long do you think you,ll live?", According ... offending over time., Author Dr. Alex Piquero said the study ... of them offend at very high rates and commit more ... much later in life offend much less., "In a lot ...
(Date:4/14/2014)... with symptoms increasing dramatically during some of the most important ... has found. , Depressive symptoms increased on average by 68 ... young men, who were around 25 years old when they ... their children. The results of the study were published April ... is the first to identify when young fathers are at ...
(Date:4/14/2014)... Lower weight babies and babies who aren,t breastfed ... risk of developing chronic inflammation and related health ... study. , "There were good reasons to hypothesize ... inflammation in adulthood," says Thomas McDade (Northwestern University), ... in the Child & Brain Development program. "It ...
Breaking Medicine News(10 mins):Health News:Researchers identify children with emotional behavior difficulties 2Health News:Researchers identify children with emotional behavior difficulties 3Health News:Study links severe sleep apnea to increased risk of stroke, cancer and death 2Health News:UT Dallas study: Youth who fail to envision future commit more crimes 2Health News:Young dads at high risk of depression, too 2Health News:Low birth weight, less breastfeeding create later health risks 2
... the nation,s leader in pain prescription monitoring, announced ... with Aetna to offer Aetna,s network of providers ... monitoring process. Ameritox,s patented Rx Guardian(SM) methodology is ... a patented methodology to help physicians assess whether ...
... The Ohio State University , Cardinal Health and ... a collaboration that will invest more than $10 million ... industry, combining Ohio State,s Wright Center of Innovation in ... commercialization expertise for molecular imaging agents.Molecular imaging is one ...
... LINE OF NATURAL, NON-TOXIC AND EFFECTIVE HOUSEHOLD CLEANERS OFFER ... FAMILIES CLEAN AND SAFENEW YORK, April 29 ... Kevin Schwartz and Keith Garber of KAS Direct, founders ... cleaning solutions for households with infants and growing families ...
... Security Intelligence, and Risk Management Tools Now All in One ... ... swine flu, political instability, kidnapping and piracy dominating global headlines, MEDEX ... intelligence across medical, security, travel and risk management disciplines. By ...
... released today by the Center to Expose and Close Animal ... Close Animal Factories (CECAF) will hold a media teleconference to ... "factories." Among the topics will be Smithfield Foods at ... Officials in Mexico are looking at "manure lagoons" and ...
... Action to Protect Public,s Oral HealthCHICAGO, April 29 ... exclusively for the general dentist, reminds legislators that dentistry is ... must be taken into consideration in any effort by Congress ... critical issue for general dentistry is access to care. The ...
Cached Medicine News:Health News:Ameritox(R) Contracts With Aetna for Prescription Drug Monitoring Services 2Health News:The Ohio State University, Cardinal Health, State of Ohio to Invest $10 Million to Advance Medical Imaging Industry 2Health News:Preventative Safety Tips Timed to Swine Flu Outbreak 2Health News:MEDEX Announces New, Enhanced and Customizable Member Center 2Health News:MEDEX Announces New, Enhanced and Customizable Member Center 3Health News:MEDEX Announces New, Enhanced and Customizable Member Center 4Health News:Academy of General Dentistry Access to Care White Paper 2
Bausch & Lomb round and rectangular magnifiers incorporate precision optics and an ergonomic design for increased clarity and comfort during use...
Adjustable piston accommodates 7 - 9 mm trephine blade. Complete punch includes base plate, piston carrier, piston for 7 - 9 mm trephine blades and 18 mm diameter Teflon block. Designed for accurate ...
... allows the surgeon to effectively ... scrub-resistant, gentian violet ink. All ... sterile, with a ruler and ... pouches. Micro tip marker for ...
Broad tip, gentian violet, sterile, disposable...
Medicine Products: