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. Highlights included:

  • Survival to cardiac transplantation, recovery or ongoing on HeartMate II support was 80 percent at six months and 77 percent at one year.

  • Eighty-four percent of the patients survived to hospital discharge or transplantation.

  • The incidence of major adverse events with comparable definitions -- including infections, strokes and bleeding requiring surgery -- was significantly lower than what was clinically observed in the previous bridge-to-transplantation study of the HeartMate VE LVAS (HeartMate IIs predecessor).

Currently, NewYork-Presbyterian Hospital/Columbia University Medical Center is participating in a clinical trial of HeartMate II as a long-term therapy (also known as destination therapy) that could potentially also serve as a permanent support option for these patients.


'/>"/>

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

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:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... are unfamiliar with. The article goes on to state that individuals are now more ... these less common operations such as calf and cheek reduction. The Los Angeles area ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension ... that it will receive two significant new grants to support its work to ... its 25th anniversary by recognizing patients, medical professionals and scientists for their work ...
(Date:6/24/2016)... ... ... makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum ... by 2020 and then adjusting it yearly to increase at the same rate as the ... wage floor does not erode again, and make future increases more predictable. , The company ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions ... initiated cultivation and processing operations at its production facility, and opened its first ... is the manufacturer of a complete system of proactive air and surface purification ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016 Research and ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" report ... In-Mold Electronics, Smart Skin, Structural Health Monitoring, ... Structural electronics involves electronic and/or electrical components ... replacing dumb structures such as vehicle bodies or ...
(Date:6/24/2016)... CLEMENTE, Calif. , June 24, 2016  American Respiratory Labs ... company, is now able to perform sophisticated lung assessments in patients, ... Technologies , Inc. Patients are no longer limited ... ndd,s EasyOne PRO ® , ARL patients like Jeanne R. of ... done in the comfort of her own home. ...
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ., ... developing innovative inhaled drugs, announced today that it was ... Investments reconstituted its comprehensive set of U.S. and ... "This is an important milestone for Pulmatrix," said Chief ... shareholder awareness of our progress in developing drugs for ...
Breaking Medicine Technology: