St. Jude Medical, Inc. has gained CE mark approval for a 25 mm iteration of its Portico™ Transcatheter Aortic Heart Valve Implantation System, extending the applicability of the device to more patients for whom transcatheter aortic valve replacement (TAVR) is indicated.
TAVR is an option for patients with symptomatic severe aortic stenosis. Such patients are considered high-risk for conventional open-heart valve replacement surgery.
St. Jude claims Portico 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. 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 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.
“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 millimeter 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 J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division.
Source: St. Jude Medical, Inc., Business Wire