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.
The approval indication is in line with the entry criteria of PORTICO IDE, the investigational device exemption trial from which the FDA largely made its decision.
With the self-expanding Portico valve, Abbott joins two other companies with TAVR valves on the US market: Medtronic with the self-expanding Corevalve Evolut (Medtronic) line, and Edwards Lifesciences with its Sapien (Edwards Lifesciences) valves, both of which can be used in patients at low surgical risk.
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