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

HOUSTON, Dec. 16, 2011 /PRNewswire/ -- Newborns, toddlers and teens who suffer from heart failure and need heart transplantation to survive just got a life-saving pediatric heart pump that buys time and allows them to grow stronger as they wait for a donor heart.

Texas Children's Hospital in Houston, the lead center in a 17-hospital national Investigational Device Exemption (IDE) study on the German-manufactured Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD), announced today that the FDA has granted a Humanitarian Device Exemption (HDE) approval for the EXCOR to be used in U.S. children as a bridge to heart transplantation. To watch a video on the significance of the Berlin Heart, please see: http://youtu.be/Gj8gM4MignI.

The EXCOR, used to provide circulatory support to pediatric patients with severe heart failure, is the only VAD approved in the U.S. for use in babies. The pump allows pediatric patients from newborns to teens to remain active so they grow stronger and meet developmental milestones as they await donor hearts.

"I am extremely gratified that the FDA has granted an HDE approval to the EXCOR Pediatric VAD," said Dr. Charles D. Fraser, Jr., surgeon-in-chief at Texas Children's Hospital, professor of surgery and pediatrics at Baylor College of Medicine and national principal investigator for the North American Berlin Heart EXCOR Pediatric study. "This ushers in a new era for children with terminal heart failure. The medical community is now able to offer this life-saving device to support desperate children who would not otherwise survive while awaiting donor hearts. The study involved an incredible effort from 15 U.S. hospitals and two Canadian centers with extensive experience in pediatric heart failure and transplantation. It should serve as a model for future collaborative device studies involving children, industry, medicine and the FDA."

Texas Children's Heart Cen
'/>"/>

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:3/3/2015)... 3, 2015  Cyberonics, Inc. (NASDAQ: CYBX ... treatment and management of epilepsy, today announced it will ... March 11, 2015, in Miami . ... Chief Executive Officer, will speak at 1:05 PM Eastern ... chat format, and no formal materials will be presented.  ...
(Date:3/3/2015)... March 3, 2015  The eleventh annual Tucson Symposium ... the world,s top research scientists, academics, oncologists and pathologists ... and learn about new outcomes in patient treatments that ... Each year Ventana Medical Systems, Inc. (Ventana), ... the Tucson Symposium at the Hilton El Conquistador in ...
(Date:3/3/2015)... 3, 2015 /CNW/ - ChipCare Corporation, a University of ... for HIV and other infectious and non-communicable diseases ... to bring its first-generation product to market while ... (Photo: http://photos.prnewswire.com/prnh/20150303/179107 ) ... simple, accurate and affordable diagnostic tests makes it ...
Breaking Medicine Technology:Global scientific collaborators to explore latest pathology and oncology advancements at Tucson Symposium 2ChipCare Closes Oversubscribed $5 Million Series A Financing 2ChipCare Closes Oversubscribed $5 Million Series A Financing 3
... 23, 2011 Valeant Pharmaceuticals International, Inc. (the "Company" ... Notice of Intention to make a normal course issuer ... that the TSX has accepted the Notice of Intention. ... to purchase for cancellation, commencing August 25, 2011, 1,000,000 ...
... 2011 Bacterin International Holdings, Inc. (NYSE Amex: ... revolutionary bone graft material and antimicrobial coatings for medical applications, ... Annual Global Investment Conference. The conference will be held at ... 11-13, 2011. Bacterin,s chairman and CEO, Guy Cook, ...
Cached Medicine Technology:Valeant Pharmaceuticals Files a Notice of Intention to Make a Normal Course Issuer Bid 2Valeant Pharmaceuticals Files a Notice of Intention to Make a Normal Course Issuer Bid 3Bacterin International to Present at Rodman & Renshaw Annual Global Investment Conference on September 12, 2011 2
(Date:3/3/2015)... (PRWEB) March 03, 2015 A recent ... confirms what water advocate and radio host Sharon Kleyne ... – lack of sufficient water in the body – ... as 90 percent of the US population. Kleyne further ... a factor in nearly all disease, including aging and ...
(Date:3/3/2015)... WA (PRWEB) March 03, 2015 After ... to a lifestyle of fitness and exercise. Community Health ... article presenting 6 ways that families in Everett, ... during the winter months. , CHC says, “While ... grilled chicken and steamed veggies, many families wonder how ...
(Date:3/3/2015)... N.C. (PRWEB) March 03, 2015 ... pre-hire clinical and health care testing, is now ... its behavioral assessments. The result of acquiring the ... provider, PeopleClues in late 2014, the research will ... be used by hospitals, providers, healthcare staffing organizations ...
(Date:3/3/2015)... MO (PRWEB) March 03, 2015 Extend Nutrition, ... to reduce the amount of calories consumed at the next ... “Snack-2-Health Kit.” There are no lifestyle changes needed and ... 2 snacks per day. , The starter kit contains 60 ... a patented blend of protein, fiber, healthy fat and complex ...
(Date:3/3/2015)... NJ (PRWEB) March 03, 2015 Getting to ... when our health and well-being are at stake. So when ... their ability to move about pain-free – it’s vital to ... of this crucial resource, according to Sridhar Yalamanchili, PT, MSPT, ... , A September 2014 nationwide survey by the ...
Breaking Medicine News(10 mins):Health News:Study linking dehydration and stroke severity supports fresh water advocate’s warnings 2Health News:Study linking dehydration and stroke severity supports fresh water advocate’s warnings 3Health News:6 Wintertime Weight Loss Tips for Family Fitness Presented by Community Health Center of Snohomish County in Recent Article 2Health News:Prophecy Healthcare Acquires IP to Expand Behavioral Benchmarks 2Health News:Prophecy Healthcare Acquires IP to Expand Behavioral Benchmarks 3Health News:Snack Your Way to a Smaller Waistline with Extend Nutrition’s New “Snack-2-Health Kit” 2Health News:Snack Your Way to a Smaller Waistline with Extend Nutrition’s New “Snack-2-Health Kit” 3Health News:Separating Fact from Fiction about Physical Therapy 2Health News:Separating Fact from Fiction about Physical Therapy 3
... it was found that the chest circumference records are beating ... it was found that better nutrition was the main reason. ... that the average chest circumference of Chinese women has increased ... This change was seen only from early 1990s. ...
... most Americans prefer a sandbag workout when compared to a ... brought into focus the latest in fitness craze across the ... a comparable load to what workers of the construction site ... to ‘heave-ho their way to fitness’ by moving around heavy ...
... DTNBP1 that appears to influence human intelligence. This ... manipulation techniques to enhance an individual's intellectual skills. ... of individuals afflicted with schizophrenia; a disorder marked ... with those of normal individuals. This lead to ...
... directed at B-cells could turn out be more effective ... disease arising out of an auto immune disorder.// ... form of biologic therapy for treatment of rheumatoid arthritis ... patients who exhibit resistance to conventional DMARDs. The effect, ...
... researchers at Columbia University Medical Center to analyze the ... cancer treatment, //it has been found that nearly one ... specifically, stage III colon cancer patients who were prescribed ... were found to stop their treatment before completion. ...
... Many of Britain’s workers frequently report sick due to ... to 3000 people develop// occupational asthma every year. Prolonged ... trigger occupational asthma. ,Alveolitus or 'occupational asthma’ is ... an allergic inflammation of the lung. It is ...
Cached Medicine News:Health News:Human Intelligence Gene Identified By Scientists 2Health News:B-Cell Biologic Therapy Could Revolutionize Rheumatoid Arthritis Treatment 2Health News:B-Cell Biologic Therapy Could Revolutionize Rheumatoid Arthritis Treatment 3Health News:Colon Cancer Death Rate Doubles As Patients Stop Chemotherapy 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: