Navigation Links
FDA Approves First Artificial Aortic Heart Valve Placed Without Open-Heart Surgery
Date:11/2/2011

te of the diseased valve. The heart valve is then released from the delivery catheter and expanded with a balloon and is immediately functional.  

The FDA's approval of the Sapien THV is based on a study in 365 patients who were not eligible for open-heart surgery. Half of the patients received the Sapien valve. The other study patients received another treatment that did not require open-heart surgery. One alternative procedure involved enlarging the aortic valve opening by stretching it with a balloon (balloon valvuloplasty).

Patients receiving the Sapien valve experienced two and a half times more strokes and eight times as many vascular and bleeding complications than patients who did not receive the implant; however, they were more likely to survive one year after surgery. After a year, 69 percent of the Sapien patients were alive compared with 50 percent of those who received an alternative treatment.

Edwards Lifescience, the manufacturer of the Sapien THV, will continue to evaluate the outcomes with the Sapien THV through a national Transcatheter Valve Therapy (TVT) registry. The Society of Thoracic Surgeons and the American College of Cardiology have been working with the FDA and the Centers for Medicare and Medicaid Services to facilitate the creation of the national TVT registry that will serve as a platform for continued evaluation of post market experience with this and future transcatheter devices and procedures for the treatment of aortic stenosis.

The most common serious and potentially life-threatening side effects in patients receiving the Sapien valve and the procedure to implant the valve include death, stroke, perforation of the blood vessels, ventricle or valvular structures, damage to the conduction system in the heart, significant bleeding, and leaks around the new valve.

The Sapien THV is approved for patients who are not eligible for open-heart surgery for replacement of their aortic valve and have
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... 2014  Ameritox SM , the nation,s leader in ... Drugs to Heroin," a research report that provides concrete ... examines deadly trends that have created a unique heroin ... The report is based on data ... It examines five trends that distinguish the heroin abuse ...
(Date:9/2/2014)... , Spanje, September 2, 2014 ... GARFIELD AF Registry bij het ESC CONGRESS ... bij patiënten met risico op beroerte in ... Gegevens van bijna 12.500 patiënten ingeschreven ... FIELD-Atrial Fibrillation (GARFIELD-AF), een innovatief, onafhankelijk initiatief ...
(Date:9/2/2014)... 2014 Donald Spector , a renowned ... 8,823,512 for a Wearable Biosensor, which will issue today, ... this field.  Mr. Spector holds some of the earliest ... made today by New York College of Health Professions, ... of world-class intellectual properties.  New York College noted that ...
Breaking Medicine Technology:Ameritox Research Report Reveals Pain Patients' Role in Current Heroin Epidemic 2Gegevens uit wereldwijde atriumfibrillatieregister tonen aan dat antistollingsmiddelen niet optimaal worden gebruikt ter preventie van beroerte 2Gegevens uit wereldwijde atriumfibrillatieregister tonen aan dat antistollingsmiddelen niet optimaal worden gebruikt ter preventie van beroerte 3Gegevens uit wereldwijde atriumfibrillatieregister tonen aan dat antistollingsmiddelen niet optimaal worden gebruikt ter preventie van beroerte 4Gegevens uit wereldwijde atriumfibrillatieregister tonen aan dat antistollingsmiddelen niet optimaal worden gebruikt ter preventie van beroerte 5Gegevens uit wereldwijde atriumfibrillatieregister tonen aan dat antistollingsmiddelen niet optimaal worden gebruikt ter preventie van beroerte 6Gegevens uit wereldwijde atriumfibrillatieregister tonen aan dat antistollingsmiddelen niet optimaal worden gebruikt ter preventie van beroerte 7Gegevens uit wereldwijde atriumfibrillatieregister tonen aan dat antistollingsmiddelen niet optimaal worden gebruikt ter preventie van beroerte 8Gegevens uit wereldwijde atriumfibrillatieregister tonen aan dat antistollingsmiddelen niet optimaal worden gebruikt ter preventie van beroerte 9Gegevens uit wereldwijde atriumfibrillatieregister tonen aan dat antistollingsmiddelen niet optimaal worden gebruikt ter preventie van beroerte 10Wearable Biosensor Patent, the Grandfather of Wearable Biosensor Transmission Patents, Granted to Donald Spector, One of the Most Prolific Living Inventors in the World 2Wearable Biosensor Patent, the Grandfather of Wearable Biosensor Transmission Patents, Granted to Donald Spector, One of the Most Prolific Living Inventors in the World 3Wearable Biosensor Patent, the Grandfather of Wearable Biosensor Transmission Patents, Granted to Donald Spector, One of the Most Prolific Living Inventors in the World 4Wearable Biosensor Patent, the Grandfather of Wearable Biosensor Transmission Patents, Granted to Donald Spector, One of the Most Prolific Living Inventors in the World 5
... AMN Healthcare Services, Inc. (NYSE: AHS ), the largest ... quarterly conference call to discuss third quarter results on Thursday, ... also expects to issue an earnings news release on Thursday, ... 4:00 p.m. Eastern Time. , A live webcast of the ...
... CPhI Worldwide and connected events - the global pharma ingredients and ... - 15 October for its 20th staging. , The co-located ... technology events are joined for 2009 under the Where Pharma ... The new platform markedly reflects the notable convergence of the pharma ...
Cached Medicine Technology:AMN Healthcare Services to Host 2009 Third Quarter Earnings Conference Call on Thursday, October 29, 2009 2CPhI 2009: Madrid Launch for BioPh Marks Pharma and Biotech Convergence 2CPhI 2009: Madrid Launch for BioPh Marks Pharma and Biotech Convergence 3
(Date:9/2/2014)... (HealthDay News) -- Drinking and marijuana may lead to ... study suggests. Researchers analyzed 2007 to 2011 data ... who said they had used alcohol or marijuana at ... was associated with more unsafe driving, damage to relationships ... while under the influence of alcohol, especially among females. ...
(Date:9/2/2014)... apnea, tonsillectomies, hearing loss, head and neck cancers ... Orlando, FL, September 21-24, at the 2014 Annual ... of OtolaryngologyHead and Neck Surgery Foundation (AAO-HNSF), the ... and neck physicians in the world. , Abstracts ... today, and are available online at http://oto.sagepub.com/content/151/1_suppl ...
(Date:9/2/2014)... Last year, SIGVARIS took graduated ... of a luxurious line of graduated compression socks with natural ... COTTON Socks are joining the SIGVARIS MEDICAL collection for those ... comfort of natural cotton fibers. , “When people step ... find socks as soft as the finest cashmere,” says Clay ...
(Date:9/2/2014)... 02, 2014 The exclusive ClinicCRM patient ... designed to help doctors manage foreign patient flow, enable ... conversion rates and clink revenue. Since its launch in ... in sales revenue and a 70 percent increase in ... their own healthcare practices. , With its ease of ...
(Date:9/2/2014)... of Experimental Biology and Medicine that ... biology and medicine of microphysiological systems" and describes ... Systems Program directed by the National Center for ... of Health (NIH) and funded in part by ... Projects Agency (DARPA) and the Food and Drug ...
Breaking Medicine News(10 mins):Health News:Booze, Pot Bad for Teens in Different Ways, Study Suggests 2Health News:SIGVARIS’ Luxury Line of Compression Socks, SEA ISLAND COTTON, Now Available in Stronger Compression Level 2Health News:Doctors Abroad Using VisitandCare.com Patient Management Software Report 60% Increase in Revenue 2Health News:Doctors Abroad Using VisitandCare.com Patient Management Software Report 60% Increase in Revenue 3Health News:Doctors Abroad Using VisitandCare.com Patient Management Software Report 60% Increase in Revenue 4Health News:Microphysiological systems will revolutionize experimental biology and medicine 2Health News:Microphysiological systems will revolutionize experimental biology and medicine 3
... , , , ... Sustained reduction of mitral regurgitation following mitral valve repair ... (DMR) or functional mitral regurgitation (FMR) led to heart function ... initial registry cohort of the EVEREST (Endovascular Valve Edge-to-Edge REpair ...
... , , , , ... over 2,000 motorcycle riders and enthusiasts will gather at Wisconsin Harley-Davidson ... "Ridin, to a Cure" fund raiser for breast cancer research in ... raise in excess of $300,000 over the weekend. The ride has ...
... , , One of Nation,s Best ... The health care network operated by the Department of Veterans Affairs (VA) has ... by the American Association of Retired Persons (AARP). , , "Quality ... Affairs Eric K. Shinseki. "VA is proud to be recognized as a top ...
... CHELMSFORD, Mass., Sept. 22 Magellan Biosciences, Inc. (Magellan), ... Life Sciences Tools (LST) business to Sunnyvale, California-based Dionex, Inc. ... ESA,s HPLC-related products, HPLC clinical assays, the ESA Laboratories services ... Financial terms of the transaction were not disclosed. , ...
... VA Physical therapist-directed exercise counseling combined with ... and exercise capacity in people with type 2 ... exercise, according to a randomized clinical trial published ... , the scientific journal of the American Physical ...
... Mo. About 2 million Americans currently use cocaine ... to making it one of the most dangerous and ... cause severe biological and behavioral problems, is very difficult ... and Sandeep Pendyam, doctoral students in the Department of ...
Cached Medicine News:Health News:MitraClip(R) Therapy Data Demonstrate Significant Left Ventricular Reverse Remodeling in Patients With Sustained Reduction of Mitral Regurgitation 2Health News:MitraClip(R) Therapy Data Demonstrate Significant Left Ventricular Reverse Remodeling in Patients With Sustained Reduction of Mitral Regurgitation 3Health News:We Need Your Support - 'Ridin' to a Cure' Sept. 25 and 26 2Health News:VA's Health System Top Employer for AARP 2Health News:Magellan Biosciences Sells its Life Sciences Tools Business to Dionex 2Health News:Magellan Biosciences Sells its Life Sciences Tools Business to Dionex 3Health News:People with type 2 diabetes improved muscular strength 2Health News:Computer model shows changes in brain mechanisms for cocaine addicts 2
Neomycin and Polymyxin B Sulfates and Hydrocortisone otic suspension, USP is a sterile antibacterial and anti-inflammatory suspension for otic use....
Prednisolone Acetate ophthalmic suspension USP, 1% is an adrenocortical steroid product prepared as a sterile ophthalmic suspension....
... A sophisticated research tool that allows ... area which is being stimulated. Besides it ... the examiner to switch between the pupil ... computer screen. This system is especially suited ...
The only air-based esthesiometer with a database of normal sensation on the cornea. May have application to the measurement of normal-tension glaucoma....
Medicine Products: