Navigation Links
FDA approves HeartMate II mechanical heart pump for heart-failure patients
Date:5/2/2008

NEW YORK (April 25, 2008) -- Heart failure patients at NewYork-Presbyterian Hospital/Columbia University Medical Center were among the first to be implanted with the HeartMate II LVAS (Left Ventricular Assist System) -- a miniature mechanical pump that helps weak hearts pump blood -- that has now received approval by the FDA as of April 21 for broad use as bridge to transplantation. As part of clinical trials leading to approval, 22 patients received the new device at NewYork-Presbyterian/Columbia -- more than any other hospital in the New York area.

Clinical research studies at medical centers, including NewYork-Presbyterian/Columbia, showed the HeartMate II to be safe and effective, with improved quality of life and survival compared with historical norms for heart-failure patients. In addition, the device is designed to be quieter and more durable than other FDA approved devices.

One-eighth the size of the original HeartMate LVAS, the HeartMate II provides continuous blood flow through the circulatory system using only one moving part -- a rotary pumping mechanism.

"For patients whose hearts are unable to effectively pump blood due to severe heart failure, this remarkable device can help them have active lives as they await a heart transplant," says Dr. Yoshifumi Naka, principal investigator of the clinical research studies and director of cardiac transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center and associate professor of surgery at Columbia University College of Physicians and Surgeons.

With around 2,200 donor hearts available annually, there are large numbers of patients with end-stage heart failure placed on heart transplant waiting lists. These patients would be candidates to receive the HeartMate II LVAS as a therapeutic option to sustain them until transplant.

FDA approval was based on one-year follow-up data from the first 194 HeartMate II patients enrolled in the trial
'/>"/>

Contact: Belinda Mager
212-305-5587
New York- Presbyterian Hospital/Columbia University Medical Center
Source:Eurekalert

0

GOOD

Page: 1 2

Related medicine news :

1. FDA Approves Advair(R) 250/50 for Reduction of Exacerbations in Patients With COPD
2. FDA Approves New Once-a-Month Dose of Actonel for Postmenopausal Osteoporosis
3. FDA approves VYVANSE, first and only once-daily prodrug stimulant to treat ADHD in adults
4. FDA APPROVES ROTARIX(R) [Rotavirus Vaccine, live, oral], THE FIRST VACCINE LICENSED TO COMPLETE THE ROTAVIRUS IMMUNIZATION SERIES BY FOUR MONTHS OF AGE
5. House Overwhelmingly Approves Renewal and Tripling of Successful U.S. Global AIDS Prevention Effort
6. VeriPrime Approves New Best Practices for Beef Production
7. U.S. EPA Approves Registration of Antimicrobial Copper Alloys
8. Arizona Senate Approves Smoking Cessation Treatments for State Medicaid Beneficiaries
9. CMS Approves Home Sleep Testing for Diagnosis of OSA; AASM Experts Available for Comment
10. FDA Approves Abbotts FreeStyle Navigator(R) Continuous Glucose Monitoring System
11. FDA Approves Aloxi(R) (Palonosetron HCL) Injection for Prevention of Postoperative Nausea and Vomiting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/18/2013)... Each year, the American Gastroenterological Association (AGA) ... achievements in gastroenterology through its esteemed recognition awards. ... talented individuals who work tirelessly to advance the ... pleased to announce the 2013 recognition award honorees ... their tremendous contributions to our field," said Loren ...
(Date:5/18/2013)... 18, 2013 Also known as ... popular weight loss surgery that guarantees patients long-term weight ... Center wishes to give readers a brief tutorial on ... medical school at New York City’s Mount Sinai School ... he undertook a fellowship in Minimally Invasive Bariatric Surgery. ...
(Date:5/18/2013)... Illuminations is proud to present the Inner ... will take place over the course of four days, on ... Saturday, June 8, 2013. , Inner Child Therapy is concerned ... the attitudes, patterns and coping mechanisms that create the behavior ... to live a more integrated and balanced life style, to ...
(Date:5/18/2013)... swallow high-powered magnets often need surgery and other invasive ... study. The researchers, from the Louisiana State University ... 79 percent of children who swallowed very strong "neodymium ... which a tube containing a camera is inserted into ... can be treated through observation or by pumping the ...
(Date:5/18/2013)... May 18, 2013 MOOSGO.COM published an original ... This book features a group of artists who share their ... photographs, illustrations and paintings. Exclusively for iPad . ... including songs and videos that reflect the signature idiosyncrasy and ... at the Apple iBook Store and it includes a ...
Breaking Medicine News(10 mins):Health News:AGA honors distinguished clinicians, researchers and educators with prestigious recognition awards 2Health News:AGA honors distinguished clinicians, researchers and educators with prestigious recognition awards 3Health News:AGA honors distinguished clinicians, researchers and educators with prestigious recognition awards 4Health News:AGA honors distinguished clinicians, researchers and educators with prestigious recognition awards 5Health News:Everything You Need to Know About Lap Band Surgery 2Health News:Everything You Need to Know About Lap Band Surgery 3Health News:Illuminations Brings World Renowned Therapist to the Middle East 2Health News:Swallowing Magnets Can Be Fatal for Children 2Health News:New Art Book for iPad: Tango Art 2
... the nation,s largest builder of healthcare facilities, has ... hospital for Virtua Health. Turner is serving as ... scheduled for completion in 2011. The 690,000-sq.-ft. hospital ... quality clinical services and patient safety, an assurance ...
... 30 Diagnosoft, Inc., an innovator in magnetic ... diagnosis, staging and therapeutic monitoring of cardiovascular disease, ... Strain-encoding, or SENC, is a new MRI ... contraction, or relaxation, of the heart,s myocardium. ...
... Healthcare Management Group, Inc. (Phyhealth) (Pink Sheets: PHYH), ... in partnership with physicians and manager of Physhield ... released the following letter to its shareholders:Dear Phyhealth ... Congress and a new administration in Washington. ...
... Study says initiatives should target both coverage and access to ... Children who do not have health insurance and no regular ... unmet medical needs, researchers at the University of Michigan C.S. ... government needs to do more to safeguard the health of ...
... (Nasdaq: BCRX ) today announced that its fourth ... on Friday, February 6, 2009. Following the release, BioCryst will ... Eastern Time to discuss the financial results and provide an ... by Jon P. Stonehouse, President and Chief Executive Officer, Stuart ...
... Neurosilicon,s novel Photoconductive Stimulation Device (PSD) was highlighted in ... Astrocytic Ca2+ Waves Guide CNS Growth Cones to Remote ... November 2008 issue of The Public Library of Science ... in mediating axonal guidance. It is known that the ...
Cached Medicine News:Health News:Turner Reaches Milestone on $323 Million Virtua West Jersey Replacement Hospital in Voorhees, N.J. 2Health News:Diagnosoft(R) Introduces Its Third MRI Analysis Innovation 2Health News:Phyhealth Provides Update to Shareholders 2Health News:Phyhealth Provides Update to Shareholders 3Health News:Phyhealth Provides Update to Shareholders 4Health News:Medical Needs of 6.2 Million U.S. Kids Go Unmet 2Health News:BioCryst Pharmaceuticals to Announce Fourth Quarter and Year End 2008 Financial Results on February 6, 2009 2Health News:BioCryst Pharmaceuticals to Announce Fourth Quarter and Year End 2008 Financial Results on February 6, 2009 3Health News:Novel Photoconductive Cellular Depolarization Technology Reveals Insight Into Neuronal Growth, Guidance, and Regeneration 2
(Date:5/17/2013)... 17, 2013  Sorrento Therapeutics, Inc. (OTCBB: SRNE; ... Technology Small Business Technology Transfer Research (STTR) grant ... Infectious Diseases (NIAID), a division of the National ... novel human antibody therapeutics to combat Staphylococcus ... infections, including methicillin-resistant S. aureus (MRSA), ...
(Date:5/17/2013)... , May 17, 2013  Sony Biotechnology Inc. ("Sony") ... 8-well strip holder and 130um sorting chip.  Sony will also ... on its new SH800 Cell Sorter, the EC800 flow cytometer, ... tutorials at CYTO 2013, which will be held at the ... San Diego, California , from May 20 - ...
(Date:5/17/2013)... , May 17, 2013  TechAtlas Group ... for their competitive landscape map for the Chronic ... over 90 international companies with drugs and devices ... CKD and its sequelae. (Logo:  ... , hypertension - renal denervation ...
Breaking Medicine Technology:Sorrento Therapeutics, Inc. announces its approach to developing human antibody therapeutics against MRSA receives continued support from the National Institute of Allergy and Infectious Diseases 2Sorrento Therapeutics, Inc. announces its approach to developing human antibody therapeutics against MRSA receives continued support from the National Institute of Allergy and Infectious Diseases 3Sorrento Therapeutics, Inc. announces its approach to developing human antibody therapeutics against MRSA receives continued support from the National Institute of Allergy and Infectious Diseases 4Sony Delivers New Technology for Science to CYTO 2013 2TechAtlas Group Releases Innovative Chronic Kidney Disease Landscape Map 2
... 9 Triax Pharmaceuticals, LLC announced today ... exclusive strength of tretinoin; Tretin-X 0.0375%, for the treatment ... patients that offers a between strength – ... elegant, hydrating cream vehicle. For those patients already on ...
... known as PCOS, is a silent and often mysterious disease ... risk of serious illness. PCOS is the ... of heart disease, insulin resistance, diabetes and certain cancers. It ... child bearing age, affecting 5 to 10 million women nationwide, ...
Cached Medicine Technology:New, Exclusive Strength: Tretin-X® 0.0375%(tretinoin) Cream 2Detailed Cholesterol Test Provides Vital Clues for Women in Search of PCOS Answers 2Detailed Cholesterol Test Provides Vital Clues for Women in Search of PCOS Answers 3
... enclosures are designed for ... other process gas to ... HEPA filtration, heating/cooling, humidification, ... also available, along with ...
... versatile enclosures are designed ... or other process gas ... environment. HEPA filtration, heating/cooling, ... modules also available, along ...
Ideal for chemical processing that requires downward flow of exhaust fumes. Powderful 1200 CFM blower draws fumes into sub-surface bonded charcoal filter for safe removal of organic vapors (final HEP...
This free-standing work station safely ventilates fumes upwards, away from the work surface. Optional Exhaust Purification System features bonded charcoal filters that remove organic chemical vapors ...
Medicine Products: