St. Jude Medical, Inc. has announced the first implant of its 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 (narrowing of the aortic heart valve), who are at high risk for conventional open-heart valve replacement therapy.
“We remain on track to begin a limited launch of this product in Europe before the end of 2012.”
The Portico Valve
The Portico valve features leaflets made of bovine pericardial tissue and is designed to increase physicians’ control and placement accuracy during valve deployment. It can be completely resheathed (the process of bringing the valve back into the delivery catheter) 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 trial is a non-randomized study that will take place at five European centers, and will enroll 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. Dr. Ganesh Manoharan of Royal Victoria Hospital in Belfast, U.K. 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 Dr. Manoharan, who implanted the first patient in the trial.
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.
“With the initiation of our European pivotal trial, we continue to make strides toward the commercialization of our Portico transcatheter heart valve,” said Frank J. Callaghan, president of the St. Jude MedicalCardiovascular Division. “We remain on track to begin a limited launch of this product in Europe before the end of 2012.”
Source: St Jude Medical