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Fda approves first artificial aortic heart valve placed withoutopen-heart surgery by ferujkll sdff
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Fda approves first artificial aortic heart valve placed withoutopen-heart surgery by FERUJKLL SDFF
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| Article Posted: 09/11/2012 |
| Article Views: 126 |
| Articles Written: 2023 - MORE ARTICLES FROM THIS AUTHOR |
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Fda approves first artificial aortic heart valve placed withoutopen-heart surgery |
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Business,Business News,Business Opportunities
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The U.S. Food and Drug Administration approved the first artificialheart valve that can replace an aortic heart valve damaged bysenile aortic valve stenosis without open-heart surgery. Senile aortic valve stenosis is a progressive, age-related diseasecaused by calcium deposits on the aortic valve that cause the valveto narrow. As the heart works harder to pump enough blood throughthe smaller valve opening, the heart eventually weakens, which canlead to problems such as fainting, chest pain, heart failure , irregular heart rhythms ( arrhythmias ), or cardiac arrest. Once symptoms of senile aortic stenosis occur, more than half ofpatients die within two years.
To restore normal blood flow,patients with severe aortic valve stenosis need open-heart surgeryto replace the diseased valve. However, the procedure is too riskyfor some patients. "Surgery to replace the aortic valve is an effective treatment forsevere senile aortic valve stenosis. The Sapien Transcatheter HeartValve (THV) is an example of an innovative new device that willprovide some people with this condition who can't undergo openheart surgery with the option of valve replacement," said JeffreyShuren, M.D., director of the FDA's Center for Devices andRadiological Health. "The agency remains committed to working withcompanies who are developing breakthrough treatments that will havea significant impact on patient care in the U.S." The Sapien THV is made of cow tissue and polyester supported with astainless steel mesh frame.
To replace the diseased valve, theSapien THV is compressed into the end of a long, thin, tube-likedevice called a delivery catheter. The delivery catheter, which isslightly wider than a pencil, and the Sapien THV are inserted intothe femoral artery through a small cut in the leg and threaded tothe site of the diseased valve. The heart valve is then releasedfrom the delivery catheter and expanded with a balloon and isimmediately functional. The FDA's approval of the Sapien THV is based on a study in 365patients who were not eligible for open-heart surgery. Half of thepatients received the Sapien valve.
The other study patientsreceived another treatment that did not require open-heart surgery.One alternative procedure involved enlarging the aortic valveopening by stretching it with a balloon (balloon valvuloplasty). Patients receiving the Sapien valve experienced two and a halftimes more strokes and eight times as many vascular and bleeding complications thanpatients who did not receive the implant; however, they were morelikely to survive one year after surgery. After a year, 69 percentof the Sapien patients were alive compared with 50 percent of thosewho received an alternative treatment. Edwards Lifescience, the manufacturer of the Sapien THV, willcontinue to evaluate the outcomes with the Sapien THV through anational Transcatheter Valve Therapy (TVT) registry.
The Society ofThoracic Surgeons and the American College of Cardiology have beenworking with the FDA and the Centers for Medicare and Medicaid Services to facilitate the creation of the national TVT registrythat will serve as a platform for continued evaluation of postmarket experience with this and future transcatheter devices andprocedures for the treatment of aortic stenosis. The most common serious and potentially life-threatening sideeffects in patients receiving the Sapien valve and the procedure toimplant the valve include death, stroke, perforation of the bloodvessels, ventricle or valvular structures, damage to the conductionsystem in the heart, significant bleeding, and leaks around the newvalve. The Sapien THV is approved for patients who are not eligible foropen-heart surgery for replacement of their aortic valve and have acalcified aortic annulus (calcium build-up in the fibrous ring ofthe aortic heart valve). The product label advises that a heartsurgeon should be involved in determining if the Sapien THV is anappropriate treatment for the patient. It is not approved for patients who can be treated by open-heartsurgery.
Patients who have congenital heart valve anomalies, havemasses or an infection in their hearts, or cannot tolerateanticoagulation/antiplatelet therapy should not receive the SapienTHV. Additional References Citations. I am a professional writer from Used Computers & Accessories, which contains a great deal of information about swiss music boxes , inlaid music boxes, welcome to visit!
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