St. Jude Medical, a medical device company, has obtained CE Mark approval in Europe for its 25mm Portico transcatheter aortic heart valve implantation system.
The Portico valve system offers a minimally invasive treatment option for patients with severe aortic stenosis – a narrowing of the aortic valve that obstructs blood flow from the heart.
This CE Mark approval expands the number of patients, who are considered high-risk for conventional open-heart valve replacement surgery, who can be treated using the Portico heart valve during transcatheter aortic valve replacement (TAVR) procedures.
Made of bovine pericardial tissue, the Portico valve is attached to a self-expanding stent frame. The device can be 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 25mm Portico valve supports a patient’s native annulus (a ring-shaped supporting structure in the heart) with diameters ranging from 21-23mm. The addition of 25mm valve allows the Portico platform to treat patients with an annulus ranging from 19-23mm.
St. Jude Medical plans to add two additional valve sizes to the Portico line in 2014. This addition is expected to expand the eligible range of patients to those with annulus sizes ranging from 19-27mm.
During a transcatheter procedure using the transfemoral delivery system, a physician implants the Portico valve through a catheter which has been placed through a small incision in the artery of the leg in order to gain access to the heart.
Positioned while the patient’s heart continues to beat, use of the Portico valve alleviates the use cardiopulmonary bypass.
St. Jude Medical Cardiovascular and Ablation Technologies division president Frank J Callaghan noted the Portico valve is an important part of the company’s 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," Callaghan added.
The company’s Portico 23mm and 25mm transcatheter aortic heart valves continue to be evaluated in the Portico TF CE trial. The company has recently presented favorable data from the non-randomized, multi-center study at the Transcatheter Cardiovascular Therapeutics scientific symposium, sponsored by the Cardiovascular Research Foundation.
St. Jude Medical had obtained CE Mark approval for the 23mm Portico transcatheter aortic heart valve in November 2012.
The Portico transcatheter aortic heart valve and transfemoral delivery system are not approved for use in the US.
Image: St. Jude Medical’s 25mm Portico transcatheter aortic heart valve obtains CE Mark Photo: Courtesy of St. Jude Medical, Inc.