January 2, 2014 — St. Jude Medical Inc. 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 fact that the Portico valve is repositionable prior to valve deployment helps ensure accurate placement, potentially improving patient outcomes,” said Axel Linke, M.D., University of Leipzig, Germany, and investigator in the Portico Transfemoral CE Mark Trial (Portico TF CE Trial).
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, repositioned at the implant site or retrieved before being released from the delivery system.
“The Portico valve is an important part of our growing portfolio of products that treat valvular disease and heart failure. The approval of this 25 mm valve size will allow us to expand our footprint in the global TAVR market and provide a promising solution for patients with severe aortic stenosis,” said Frank Callaghan, president, cardiovascular and ablation technologies division, St. Jude.
The 25-mm Portico valve supports a patient’s native annulus 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.
During an implant procedure, the Portico valve is delivered through a catheter after a small incision is made to the femoral artery in the leg. Positioned while the patient’s heart continues to beat, use of the Portico valve alleviates the use cardiopulmonary bypass.
The Portico 23- and 25-mm transcatheter aortic heart valves continue to be evaluated in a non-randomized, multicenter study, the Portico TF CE Trial. Data from this study was recently presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Results highlighted the valves’ hemodynamic performance 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 November 2012. The Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System are not approved for use in the United States.
For more information: www.sjmportico.com