St. Jude Medical's Portico Transcatheter Aortic Heart Valve Receives CE Mark Approval

November 19, 2012—St. Jude Medical, Inc. (St. Paul, MN) announced it has received European CE Mark approval for the 23-mm Portico transcatheter aortic heart valve and transfemoral delivery system. St. Jude Medical also advised that it intends to begin a European study of its 25-mm valve to support CE Mark approval before the end of the year.

According to St. Jude Medical, the 23-mm Portico valve is designed for patients with severe aortic stenosis who are considered to be inoperable or high risk for conventional open-heart valve replacement surgery. With leaflets made of bovine pericardial tissue attached to a self-expanding stent, the Portico device was designed to help increase physician control and placement accuracy during deployment of the valve.

Additionally, the Portico transcatheter heart valve can be completely resheathed, repositioned at the implant site, or retrieved before it is released from the delivery system. Ganesh Manoharan, MD, of Royal Victoria Hospital in Belfast, United Kingdom, commented on this in the company's press release.

“The ability to completely resheath, reposition, or retrieve the Portico valve is an important improvement over previous-generation transcatheter valves,” stated Dr. Manoharan. “This is particularly helpful in ensuring accurate placement of the valve and minimizing complications for this high-risk population.”

Dr. Manoharan recently presented first-in-human 12-month data demonstrating the safety and efficacy of the Portico heart valve at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida. He reported that there were no vascular complications, major strokes, or deaths among study patients and no new pacemakers were required. Clinical improvements that were noted at earlier follow-up intervals were sustained out to 12 months, including valve function, stated St. Jude Medical.

On November 26, St. Jude Medical announced the first patient implant of its 23-mm Portico transcatheter aortic heart valve using the transapical delivery system. The procedure was performed by Anson Cheung, MD, who is Associate Professor of Surgery and Director of Cardiac Transplant at St. Paul's Hospital in Vancouver, Canada.

In the company's press release, Dr. Cheung commented, “The Portico heart valve offers additional options in terms of resheathing, retrieving, or repositioning the valve, which in turn facilitates more accurate placement. The ability to implant a heart valve via the transapical approach provides an important alternative to treat patients who are considered high risk for conventional open heart surgery.”