US-based St. Jude Medical has implanted the first patient with its Portico transcatheter aortic valve implant in a European clinical trial.
The non-randomised study will enrol a minimum of 30 patients at five European centres, and will evaluate the safety and efficacy of the Portico heart valve in patients with severe symptomatic aortic stenosis who are at high risk for conventional open-heart valve replacement therapy.
The Portico valve will enhance physicians' control and placement accuracy during valve deployment.
Principal investigator Ganesh Manoharan said that, based on the positive feasibility study results and patient outcomes, they are looking forward to studying the use of the next-generation technology with additional patients.
St Jude Medical cardiovascular division president Frank Callaghan said that, with the start of a European pivotal trial, they plan the commercialisation of Portico transcatheter heart valve.
"We remain on track to begin a limited launch of this product in Europe before the end of 2012," Callaghan said.
An earlier feasibility study conducted at the Royal Victoria Hospital in Belfast, Northern Ireland, demonstrated the safety and device deployment characteristics of the 23mm Portico transcatheter aortic valve implant and transfemoral delivery system.
The feasibility study results showed no device or procedure-related adverse events or death, and also demonstrated that a majority of patients had trivial or no paravalvular leak after 30 days.
During the feasibility study, the valve was successfully resheathed twice, with none of the patients in the study showing clinical strokes or vascular complications.