European Trial Begins for St. Jude Medical's Portico TAVI Device

December 13, 2011—St. Jude Medical, Inc. (St. Paul, MN) announced the commencement of the European clinical trial to support CE Mark approval of its Portico transcatheter aortic valve implantation device. The company advised that a limited launch of the device is expected before the end of 2012.

According to the company, the trial will study the safety and effectiveness of the Portico heart valve for patients who have severe symptomatic aortic stenosis and are at high risk for conventional open heart valve replacement therapy. This nonrandomized study will take place at five European centers and will enroll a minimum of 30 patients who will be followed for 1 year. The primary endpoint is 30-day all-cause mortality, with secondary safety and effectiveness endpoints.

St. Jude stated that the 23-mm Portico valve will be studied with a transfemoral delivery system. However, the company noted that both transfemoral and transapical approaches are expected to be possible with the Portico valve portfolio. The device features leaflets made of bovine pericardial tissue and is designed to increase physicians' control and placement accuracy during valve deployment. The Portico can be completely resheathed, allowing physicians to reposition it at the implant site or retrieve it before the valve is released from the delivery system.

Ganesh Manoharan, MD, is the trial's Principal Investigator and performed the first implantation of the device in the trial. He commented, “Based on our experience implanting the valve during our feasibility study, and the positive patient outcomes we have seen in those patients, we are looking forward to studying the use of this next-generation technology with additional patients.”