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:5/4/2015)... -- RadiologyAuction will have their first auction starting May 5 ... the end of the auction on May 27 th ... Cr,s, Agfa and Sony, printers and GE portable x-rays ... equipment will be available at later auctions each month ... buying and selling imaging equipment, the brokers at RadiologyAuction ...
(Date:5/4/2015)... May 4, 2015 Rogne Bioscience, a privately-held ... announced that preclinical and mechanism of action data will ... of Investigative Dermatology (SID) Annual Meeting being held May ... Atlanta, Georgia . Logo - http://photos.prnewswire.com/prnh/20150501/213318LOGO ... of RON2315, a novel, low MW (<1700 daltons) peptide ...
(Date:5/4/2015)... , May 4, 2015 Bayer HealthCare ... Isis Pharmaceuticals, Inc. (NASDAQ: ISIS ) on ISIS-FXI ... for the prevention of thrombosis. Under the agreement Bayer ... areas of high unmet medical need. As part of ... therapeutic profile of ISIS-FXI Rx in an appropriate ...
Breaking Medicine Technology:RadiologyAuction Announces Event Starting On May 5th 2Rogne Bioscience to Present Data from Topical Biologic Psoriasis Program at Upcoming SID Annual Meeting 2015 2Bayer Licenses Investigational ISIS FXI(Rx) from Isis Pharmaceuticals to Develop and Commercialize for the Prevention of Thrombosis 2Bayer Licenses Investigational ISIS FXI(Rx) from Isis Pharmaceuticals to Develop and Commercialize for the Prevention of Thrombosis 3
... Group, Inc. recently published its TreatmentTrends®: Renal Anemia ... based on survey results from ... interviews conducted with ten thought leaders in nephrology.  The ... and focuses specifically on the management of renal anemia ...
... Research Group (MRG), the global authority on medical ... US cardiac resynchronization therapy defibrillator market will be ... chronic resynchronization therapy defibrillators in New York Heart ... The New York Heart Association classification system ranks ...
Cached Medicine Technology:New Report by BioTrends Examines the Treatment of Renal Anemia in China 2Positive Results From the MADIT-CRT Trial Support the Expanding Approval of Cardiac Resynchronization Therapy Defibrillators 2Positive Results From the MADIT-CRT Trial Support the Expanding Approval of Cardiac Resynchronization Therapy Defibrillators 3
(Date:5/5/2015)... BioFit Engineered Products , a ... models from its two latest lines at NeoCon 2015, ... Chicago. Headlining the company’s exhibit will be new Pro ... as well as the unveiling of the fifth model ... Ed Metzger will deliver in-booth presentations each day of ...
(Date:5/5/2015)... NY (PRWEB) May 05, 2015 With the ... clothing and enjoying the feel of warm breezes on bare ... to strategies on how to look their best in shorts, ... “More and more people are turning to laser treatments for ... aesthetician of Simply Posh Aesthetic Spa . “They're all ...
(Date:5/5/2015)... (PRWEB) May 05, 2015 “We currently have larger ... states Marta Phillips, owner of SunGrubbies.com. “We felt it was ... to find a fashionable sun hat in an extra large size ... event.” , Fashionable derby sun hats such as the ... brim are now available in an extra large size , ...
(Date:5/5/2015)... San Francisco, Calif. (PRWEB) May 05, 2015 ... available online but these have focused primarily on personal ... the National Directory of Insurance (NDOI.com) has ... licensed insurance agents in the U.S. to present their ... public marketplace. , The result is significant and two-fold. ...
(Date:5/5/2015)... York, NY (PRWEB) May 05, 2015 No ... The Centers for Disease Control and Prevention cite ... effects our everyday life: “Poor indoor air quality (pollution) can ... to chronic heart and lung problems and cancer.” , Toxic ... swallow them in contaminated food or water, or in some ...
Breaking Medicine News(10 mins):Health News:BioFit to Introduce New Models from Latest Specialized Ergonomic Seating Lines at NeoCon 2015 2Health News:BioFit to Introduce New Models from Latest Specialized Ergonomic Seating Lines at NeoCon 2015 3Health News:Laser Hair Removal: Tips for Summertime Grooming 2Health News:Laser Hair Removal: Tips for Summertime Grooming 3Health News:SunGrubbies.com, a Leading Online Retailer of Sun Protection Products, Launches Their New Extra Large Size Fashion Sun Hats Collection 2Health News:NDOI Launch Brings Commercial Insurance Online for the First Time 2Health News:NDOI Launch Brings Commercial Insurance Online for the First Time 3Health News:revitaRUGS is Offering Area Rug Cleaning Discounts in Support of Asthma and Allergy Awareness Month This May 2Health News:revitaRUGS is Offering Area Rug Cleaning Discounts in Support of Asthma and Allergy Awareness Month This May 3
... to reasearchers, a hormone is released into the blood after ... might be supportive in treating obesity. The reason for feeling ... hormone called PYY3-36 //which acts on the brain to produce ... report on the first human trial of PYY3-36. ...
... could be saved each year, if only everyone over the ... experts, Dr. Gregory Poland fe that universal vaccination in three ... by 40 to 50 per cent. Clearly vaccination can be ... per cent. ,Dr Poland proposes some changes to ...
... to the dimpled, 'orange peel' skin on the thighs, buttocks, ... all have a beneficial effect on the appearance of cellulite ... body's natural way of storing fat in women and occurs ... a dermatologist at the University of California, cellulite is now ...
... According to recent update, people with type 2 diabetes ... able to safely reduce their risk for heart disease ... runs counter to previous research, which showed niacin adversely ... the researchers used high doses of the medication. ...
... in lessening the symptoms of fibromyalgia.,Researchers at Pole Hospital, ... with fibromyalgia, a painful muscular condition whose causes are ... to routine sessions of graded aerobic exercise, supervised by ... of those in the exercise group rated themselves as ...
... feel, that we need to learn more about ... microwaves play an increasing role in everyday life - ... pagers, and text messengers. ,We often walk past ... other words, we are bathed in an invisible 'electrosmog', ...
Cached Medicine News:
Coat-A-Count PSA IRMA is an,immunoradiometric assay intended for the,quantitative measurement of,prostate-specific antigen (PSA) in serum,to aid in the management of prostate,cancer patient...
Stereo Smile II also includes a blank card and tests,at 60, 120, 240 and 480 sec of arc., ,Smile Test II Includes:, 1 demonstration card, 1 pair pediatric 3-D viewers, 1 pair infant 3-D v...
... and Evaluate Stereo Depth Perception ... 250 sec of arc). , ... Test (400 to 20 sec ... for Children (400 to 100 ...
The Emit 2000 Phenytoin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenytoin in human serum or plasma. Emit 2000 assays are designed for use with most ...
Medicine Products: