The non-randomized study, which will enroll a minimum of 30 patients, is designed to assess the safety and effectiveness of the Portico heart valve in patients with severe symptomatic aortic stenosis.
The primary endpoint is 30-day all-cause mortality while the secondary endpoints are safety and effectiveness.
The valve is made of bovine pericardial tissue and is designed to increase physicians’ control and placement during valve deployment.
The Portico transcatheter heart valve is completely resheathed and retrieved before it is released from the delivery system, facilitating physicians to reposition the valve at the implant site.
The trial will also study the 23 mm Portico valve and transfemoral delivery system, both transfemoral (delivered via the femoral artery) and transapical (delivered via a small incision in the apex of the left ventricle).
Study principal investigator Ganesh Manoharan said based on the positive patient outcomes they have seen in those patients, they are looking forward to study the use of this next-generation technology with additional patients.
St Jude Medical Cardiovascular Division president Frank Callaghan said they remain on track to begin a limited launch of this product in Europe before the end of 2012.
