St Jude Medical has implanted the first Portico transcatheter aortic valve implant (TAVI) in a European clinical trial to support CE mark approval.
The trial will study the safety and effectiveness of the Portico heart valve for patients with severe symptomatic aortic stenosis, who are at high risk for conventional open-heart valve replacement therapy.
The trial is a non-randomised study that will take place at five European centres, and will enrol a minimum of 30 patients who will be followed for one year. The primary endpoint is 30-day all-cause mortality, with secondary safety and effectiveness endpoints. Ganesh Manoharan, Royal Victoria Hospital, Belfast, UK, is the principal investigator for the trial.
“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,” said Manoharan, who implanted the first patient in the trial.
The Portico valve, with leaflets made of bovine pericardial tissue, is designed to increase physicians’ control and placement accuracy during valve deployment. The Portico transcatheter heart valve can be completely resheathed, allowing physicians to reposition the valve at the implant site or retrieve the valve, before it is released from the delivery system, an advancement over current-generation transcatheter valves.
The Portico transcatheter heart valve was designed for the estimated 400,000 patients with severe aortic stenosis who are considered to be high risk or inoperable for conventional open-heart valve replacement therapy. While the trial will 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) approaches are ultimately expected to be possible with the Portico valve portfolio.