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

a calcified aortic annulus (calcium build-up in the fibrous ring of the aortic heart valve). The product label advises that a heart surgeon should be involved in determining if the Sapien THV is an appropriate treatment for the patient.  

It is not approved for patients who can be treated by open-heart surgery. Patients who have congenital heart valve anomalies, have masses or an infection in their hearts, or cannot tolerate anticoagulation/antiplatelet therapy should not receive the Sapien THV.

Edwards Lifescience is located in Irvine, Calif.
For more information:
FDA: Medical Devices
http://www.fda.gov/MedicalDevices/default.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
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:10/25/2014)... --  Metanome, Inc. , a Houston ... was the genomic sequencing provider for Seres Health,s ( ... of SER 109, an Ecobiotic® therapeutic for the treatment ... (CDI). Metanome has provided genomic sequencing services ... Such genomic characterization has enabled the study of the ...
(Date:10/25/2014)... 2014 Best Practices designed the Medical ... a forum for sharing insights about the key ... mechanism for creating and sharing solutions through three ... from the Medical Affairs Consortium survey. ... the first roundtable of the 2014-2015 Medical Affairs ...
(Date:10/22/2014)... 22, 2014  Rescheduling of hydrocodone combination products ... pain market, according to a new primary market ... providing market research and consultation exclusively in the ... http://photos.prnewswire.com/prnh/20141021/153440 In August, ... combination products from Schedule III to Schedule II ...
Breaking Medicine Technology:Metanome Selected as Metagenomics Provider for Seres Health Clinical Trial 2Strong Participation in Best Practices' Medical Affairs Consortium Survey 2Hydrocodone: Rescheduled, Repositioned & Reinvented 2Hydrocodone: Rescheduled, Repositioned & Reinvented 3
... COLLEGEVILLE, Pa., March 30, 2007 /PRNewswire-FirstCall/ --,Wyeth ... Inc. and Lundbeck A/S presented clinical study,results ... this,week. Safety analyses suggest bifeprunox, an investigational,treatment ... with a favorable weight and lipid profile, ...
... is STD Awareness Month: Time to Pay Attention ... 2007 /PRNewswire/ -- During,National Sexually Transmitted Disease (STD) ... awareness of, and,testing for, trichomoniasis (also known as ... States. Awareness of the condition,remains low, despite the ...
Cached Medicine Technology:Safety Analyses of Clinical Data for Bifeprunox in Patients with,Schizophrenia Showed a Favorable Weight and Lipid Profile, Similar,to Placebo 2Safety Analyses of Clinical Data for Bifeprunox in Patients with,Schizophrenia Showed a Favorable Weight and Lipid Profile, Similar,to Placebo 3Safety Analyses of Clinical Data for Bifeprunox in Patients with,Schizophrenia Showed a Favorable Weight and Lipid Profile, Similar,to Placebo 4Safety Analyses of Clinical Data for Bifeprunox in Patients with,Schizophrenia Showed a Favorable Weight and Lipid Profile, Similar,to Placebo 5Safety Analyses of Clinical Data for Bifeprunox in Patients with,Schizophrenia Showed a Favorable Weight and Lipid Profile, Similar,to Placebo 6Trichomoniasis: Most Common Curable STD in U.S. Affects 7.4 Million,Annually 2Trichomoniasis: Most Common Curable STD in U.S. Affects 7.4 Million,Annually 3
(Date:10/25/2014)... October 25, 2014 TASC (Total ... and other benefits account management services, announces the ... employers save on taxes, reduce administrative workload, and ... tax savings and the efficient handling of complex, ... Suite that best meets their goals and objectives. ...
(Date:10/25/2014)... 2014 The federal judge overseeing ... ) filed against Boston Scientific Corp. in the ... Southern District of West Virginia has denied a ... in a group of cases filed on behalf ... October 21st, U.S. District Judge Joseph R. Goodwin ...
(Date:10/25/2014)... 2014 (HealthDay News) -- Not getting the right amount ... a new study suggests. Those who sleep less ... per night may be more prone to developing the ... report. The study authors concluded that duration and quality ... patients with inflammatory bowel diseases. "Both short and ...
(Date:10/25/2014)... (HealthDay News) -- October,s shorter, darker days can trigger ... according to an expert. People affected by ... tired, lack motivation and even have trouble getting out ... suicide, said Dr. Angelos Halaris, a professor in the ... Chicago Stitch School of Medicine. "Seasonal affective disorder ...
(Date:10/22/2014)... Isabel Healthcare will participate ... (ASAHP) Conference on October 22-24 in Las Vegas, NV. ... a panel discussion on Technology in Health Professions Education ... a diagnostic decision support tool and clinical education platform ... students and clinical learners. The Isabel tools help clinicians ...
Breaking Medicine News(10 mins):Health News:TASC’s New Suites Offer Tax Savings and Protection 2Health News:Transvaginal Mesh Lawsuits Move Forward, As Federal Judge Denies Motion for Summary Judgment on Punitive Damages in Florida Cases, Bernstein Liebhard LLP Reports 2Health News:Transvaginal Mesh Lawsuits Move Forward, As Federal Judge Denies Motion for Summary Judgment on Punitive Damages in Florida Cases, Bernstein Liebhard LLP Reports 3Health News:Transvaginal Mesh Lawsuits Move Forward, As Federal Judge Denies Motion for Summary Judgment on Punitive Damages in Florida Cases, Bernstein Liebhard LLP Reports 4Health News:Sleep Duration Linked to Ulcerative Colitis Risk in Study 2Health News:Dark Days Here for Folks With Seasonal Depression 2Health News:Isabel Healthcare to Participate in The Association of Schools of Allied Health Professions (ASAHP) 2014 Conference 2
... for estrogen-sensitive tumor types, study found , , SUNDAY, April ... amounts, increases the risk of breast cancer and particularly ... shows. , The findings, expected to be presented Sunday ... Cancer Research, in San Diego, are followed by a ...
... Spectrometer is suitable for use in ... potentially explosive atmospheres, PITTSBURGH, April ... The MAX300-IGX Industrial Mass Spectrometer,is suitable for use in potentially ... obtained ATEX,approval for installations in Zone 1 areas. The MAX300-IGX ...
... the University of Pennsylvania School of Medicine and Abramson ... the American Association for Cancer Research that combining two ... lines. The team is currently designing a trial to ... is resistant to many chemotherapies and to cell-death inducing ...
... Calif., April 12 Over 300,healthcare workers at Coastal ... SEIU United Healthcare Workers - West (UHW) in a,secret-ballot ... "Uniting with thousands of other caregivers as a ... difference on the things that matter most," said,Ruth Calderon, ...
... YMCA Healthy Kids Day Saturday, April 12 ... Calif., April 11 The Mt. Diablo Region,YMCA will join ... Kids Day on Saturday, April 12 from 9 a.m. to ... Irvin Deutscher Family YMCA.,An opportunity for kids and families to ...
... researchers got paid but more upset when they owned ... volunteers in clinical studies aren,t overly concerned if researchers ... trust, suggests a U.S. study. , "Though peoples, willingness ... not suffer substantially based on the types of financial ...
Cached Medicine News:Health News:Drinking May Raise Breast Cancer Risk 2Health News:Extrel CMS Announces ATEX Approval for Process Mass Spectrometer 2Health News:Penn researchers find targeted therapy combination overcomes treatment resistance in liver cancer 2Health News:Coastal Communities Hospital Workers Join United Healthcare Workers 2Health News:The Mt. Diablo Region YMCA Invites Families to 'Put Play in Your Day' and Bring Healthy Habits Home During the Nation's Largest Health Day for Children and Families 2Health News:The Mt. Diablo Region YMCA Invites Families to 'Put Play in Your Day' and Bring Healthy Habits Home During the Nation's Largest Health Day for Children and Families 3Health News:Clinical Trial Volunteers Uneasy About Some Financial Ties 2
Each handle is designed to fit a specific trephine size. For use in performing free-hand uniform donor buttons....
Each handle is designed to fit a specific trephine size. For use in performing free-hand uniform donor buttons....
Each handle is designed to fit a specific trephine size. For use in performing free-hand uniform donor buttons....
Each handle is designed to fit a specific trephine size. For use in performing free-hand uniform donor buttons....
Medicine Products: