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St. Jude Medical Gains CE Mark for Portico Transcatheter Valve
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St. Jude Medical has announced that its Portico Transcatheter Aortic Heart Valve has received CE mark approval for use via the femoral access site in patients with severe aortic stenosis who are either inoperable or high risk for conventional surgery.
The approval makes the 23-mm device the only approved transcatheter valve that can be completely resheathed, repositioned at the implant site or retrieved before it is released from the delivery system, according to a press release. It features leaflets made of bovine pericardial tissue that are attached to a self-expanding stent. The valve was designed to improve control and accuracy in positioning and placement of the valve, minimizing paravalvular leak and potentially reducing the need for implantation of a permanent pacemaker after the procedure.
The approval follows after 12-month first-in-man data were presented at Transcatheter Cardiovascular Therapeutics Scientific Symposium in October. These data showed no vascular complications, major strokes or deaths among study patients and no new pacemakers were required. Additionally, clinical improvements reported at early follow-up were sustained out to 12 months, according to the release.
St. Jude Medical plans to initiate a European study of its 25-mm valve to support CE mark approval before the end of the year.