St. Jude Medical Gains CE Mark for 25 mm Portico Transcatheter Aortic Heart Valve

December 12, 2013 — St. Jude Medical, Inc. has received European CE Mark approval for its 25 mm Portico™ Transcatheter Aortic Heart Valve Implantation System. The approval expands the number of patients who can be treated using the Portico heart valve during transcatheter aortic valve replacement (TAVR) procedures.

“The addition of the 25 millimeter Portico valve broadens the patient population that can now be treated with this family of valves,” said Prof. Gerhard Schuler, head of the department of Internal Medicine/Cardiology at the University of Leipzig in Leipzig Germany.

“The fact that the Portico valve is repositionable prior to valve deployment helps ensure accurate placement, potentially improving patient outcomes,” said Prof. Axel Linke, an investigator in the Portico Transfemoral CE Mark Trial (Portico TF CE Trial), also from the University of Leipzig.

Made of bovine pericardial tissue attached to a self-expanding stent frame, the Portico valve is the first transcatheter aortic heart valve that can be completely resheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site, or retrieved before being released from the delivery system.

The 25 mm Portico valve supports a patient’s native annulus (a ring-shaped supporting structure in the heart) with diameters ranging from 21 to 23 mm. With the addition of the 25 mm valve, the Portico platform can now treat patients with an annulus ranging from 19 to 23 mm. In 2014, St. Jude Medical expects to add two additional valve sizes to the Portico line, which will expand the eligible range of patients to those with annulus sizes ranging from 19 to 27 mm.

The Portico 23 mm and 25 mm transcatheter aortic heart valves continue to be evaluated in a non-randomized, multi-center study, the Portico TF CE Trial. Data from this study was recently presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. Results highlighted the 23 and 25 mm Portico valves’ exceptional hemodynamic performance (the ability to maximize blood flow) and improvement in the severity of patients’ heart failure symptoms as measured by the New York Heart Association (NYHA) Functional Classification System. The 23 mm Portico Transcatheter Aortic Heart Valve received CE Mark in November 2012. The Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System are not approved for use in the United States.

For additional information about the Portico valve, visit SJMPortico.com.