St Jude Medical’s new Portico trial completes first implant

St Jude Medical has announced the first implant has been successfully completed in a new clinical trial of its Portico transcatheter aortic valve.

The medical device is currently undergoing a non-randomised study among at least 30 patients across five European centres, with the aim of supporting CE Mark approval for the product.

It will assess the safety and efficacy of Portico for patients with severe symptomatic aortic stenosis who are at high risk for conventional open-heart valve replacement therapy, with reductions in mortality rates the primary endpoint.

Should the product perform as expected in the trial, St Jude Medical believes it will be able to introduce Portico to the European market in a limited capacity before the end of 2012.

Frank Callaghan, president of St Jude Medical's cardiovascular division, said: "With the initiation of our European pivotal trial, we continue to make strides toward the commercialisation of our Portico transcatheter heart valve."

This comes after the product demonstrated promising results in a recent feasibility study, results from which were presented by St Jude Medical last month.