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06-19-2015, 02:56 AM
Edwards SAPIEN 3 Aortic Heart Valve Approved in U.S.
http://cdn.medgadget.com/wp-content/uploads/2015/06/Edwards-SAPIEN-3.jpgEdwards an**unced that the FDA has issued the company approval to introduce its latest transcatheter aortic heart valve, the SAPIEN*3, including the Commander Delivery System, *to the U.S. market. The device was designed to lower the*chances of leakage around the valve, which should reduce various side-effects, including the potential for stroke.
The SAPIEN 3 **w has an outer layer of polyethylene terephthalate over the frame of the device that more consistently plugs blood flow from having a chance to pass through outside of the valve.
FDA’s decision was based on a clinical trial that included almost 600 high-risk patients.
The device received European regulatory approval (http://www.medgadget.com/2014/01/edwards-sapien-3-prosthetic-aortic-heart-valve-approved-in-europe.html) in January of last year.
Flashback:*Edwards Sapien 3 Prosthetic Aortic Heart Valve Approved in Europe… (http://www.medgadget.com/2014/01/edwards-sapien-3-prosthetic-aortic-heart-valve-approved-in-europe.html)
Product page: Edwards SAPIEN 3… (http://www.edwards.com/eu/products/transcathetervalves/Pages/sapien3.aspx)
Source: Edwards… (http://www.prnewswire.com/news-releases/edwards-receives-fda-approval-for-sapien-3-transcatheter-heart-valve-300101101.html)
The post Edwards SAPIEN 3 Aortic Heart Valve Approved in U.S. (http://www.medgadget.com/2015/06/edwards-sapien-3-aortic-heart-valve-approve-in-u-s.html) appeared first on Medgadget (http://www.medgadget.com).
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http://cdn.medgadget.com/wp-content/uploads/2015/06/Edwards-SAPIEN-3.jpgEdwards an**unced that the FDA has issued the company approval to introduce its latest transcatheter aortic heart valve, the SAPIEN*3, including the Commander Delivery System, *to the U.S. market. The device was designed to lower the*chances of leakage around the valve, which should reduce various side-effects, including the potential for stroke.
The SAPIEN 3 **w has an outer layer of polyethylene terephthalate over the frame of the device that more consistently plugs blood flow from having a chance to pass through outside of the valve.
FDA’s decision was based on a clinical trial that included almost 600 high-risk patients.
The device received European regulatory approval (http://www.medgadget.com/2014/01/edwards-sapien-3-prosthetic-aortic-heart-valve-approved-in-europe.html) in January of last year.
Flashback:*Edwards Sapien 3 Prosthetic Aortic Heart Valve Approved in Europe… (http://www.medgadget.com/2014/01/edwards-sapien-3-prosthetic-aortic-heart-valve-approved-in-europe.html)
Product page: Edwards SAPIEN 3… (http://www.edwards.com/eu/products/transcathetervalves/Pages/sapien3.aspx)
Source: Edwards… (http://www.prnewswire.com/news-releases/edwards-receives-fda-approval-for-sapien-3-transcatheter-heart-valve-300101101.html)
The post Edwards SAPIEN 3 Aortic Heart Valve Approved in U.S. (http://www.medgadget.com/2015/06/edwards-sapien-3-aortic-heart-valve-approve-in-u-s.html) appeared first on Medgadget (http://www.medgadget.com).
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