St. Jude Medical's 25-mm Portico TAVR System Approved in Europe

December 12, 2013—St. Jude Medical, Inc. (St. Paul, MN) announced that it has received European CE Mark approval for the 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 25-mm Portico valve supports a patient's native annulus with diameters ranging from 21 to 23 mm.

According to St. Jude Medical, the 23-mm Portico TAVR device received CE Mark approval in November 2012. 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 valve, which is composed of bovine pericardial tissue attached to a self-expanding stent frame, can be completely resheathed, repositioned at the implant site, or retrieved before being released from the delivery system. The Portico valve and transfemoral delivery system are not approved for use in the United States, advised the company.

Prof. Gerhard Schuler, MD, head of the department of Internal Medicine/Cardiology at the University of Leipzig in Leipzig, Germany and Prof. Axel Linke, MD, from the University of Leipzig, commented on the approval in the company's press release.

“The addition of the 25-mm Portico valve broadens the patient population that can now be treated with this family of valves,” stated Prof. Schuler. Prof. Linke, who is an investigator in the Portico Transfemoral CE Mark Trial (Portico TF CE Trial) added, “The fact that the Portico valve is repositionable prior to valve deployment helps ensure accurate placement, potentially improving patient outcomes.”

St. Jude Medical noted that the Portico 23-mm and 25-mm TAVR devices continue to be evaluated in the nonrandomized, multicenter Portico TF CE Trial. Data from this study were presented in October at the TCT 2013: Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, California. The results demonstrated the 23- and 25-mm Portico valves' hemodynamic performance and improvement in the severity of patients' heart failure symptoms.