FDA Approves Abbott's Portico Valve for TAVR

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fairly difficult
The approval, based largely on the recently published PORTICO-IDE trial, is for patients with severe symptomatic aortic stenosis at 'high or extreme' surgical risk.
The US Food and Drug Administration has approved the Portico with FlexNav (Abbott) transcatheter aortic valve replacement (TAVR) system for patients with "symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery," the company announced today.

Steve Stiles
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