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Home Industry News St Jude Medical receives EU approval for 25 mm Portico valve

St Jude Medical receives EU approval for 25 mm Portico valve

16th December 2013

St Jude Medical has announced that its new 25 mm Portico transcatheter aortic heart valve implantation system has been granted European CE Mark accreditation.

This approval expands the number of patients who can benefit from the use of the device during transcatheter aortic valve replacement (TAVR) procedures, an option for people with symptomatic severe aortic stenosis who are considered high-risk for conventional open-heart valve replacement surgery.

Key benefits of the device demonstrated during clinical studies include the fact it is repositionable prior to valve deployment, helping to ensure accurate placement and potentially improving patient outcomes.

In 2014, the company expects to add two additional valve sizes to the Portico line.

Frank Callaghan, president of the St Jude Medical cardiovascular and ablation technologies division, said: "The approval of this 25 mm valve size will allow us to expand our footprint in the global TAVR market and provide a promising solution for patients with severe aortic stenosis."

Clinical data revealed earlier this year showed that the Portico 23 and 25 mm valves both provided a significant improvement in valve function at 30 days among patients diagnosed with severe aortic stenosis.ADNFCR-8000103-ID-801672962-ADNFCR

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