Novel Heart Valve to fit without Surgery

Novel Heart Valve to fit without Surgery

An option is available for those, who are not strong enough to go through open-heart surgery. A novel valve known as the Sapien Transcatheter Heart Valve has got 11-0 vote in its favor from the FDA advisory panel.

The valve is such that it can be fitted in heart without undergoing any kind of surgery. The Food and Drug Administration's panel said that they are quite impressed with the novel artificial heart valve.

Though no major information is available on the device, there can be side effects to it as well. The device got approval in 2011, but now the company wants to expand its horizon and want to try the drug on more number of patients.

The company said that their earlier approval was based on their trial, and now they have evidence that it is suitable for high risk patients as well. In order to test the device, 699 high-risk older patients were being recruited. The total number was divided into three groups, first group was asked to undergo transfemoral procedures, other group was asked to undergo ransapical access procedures, and rest others got the device.

"We'll have to make sure to do everything we can to lower the risk. But it's never going to be zero”, said panelist Gregory Dehmer, about risks involved.


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