Medical technology developer St Jude Medical has obtained CE Mark approval for its 25mm Portico transcatheter aortic heart valve implantation system, designed to treat patients with severe aortic stenosis who are inoperable or high-risk for open-heart surgery.
The 25mm Portico valve supports a patient's native annulus (a ring-shaped supporting structure in the heart) with diameters ranging from 21mm to 23mm.
With the addition of the 25mm valve, the Portico valve broadens the patient population that can now be treated with an annulus ranging from 19mm to 23mm.
These patients are candidates for a transcatheter aortic valve replacement (TAVR) procedure, as many are considered high-risk for conventional open-heart valve replacement surgery.
University of Leipzig professor and investigator in the Portico transfemoral CE Mark Trial (Portico TF CE Trial) Axel Linke said: "The fact that the Portico valve is repositionable prior to valve deployment helps ensure accurate placement, potentially improving patient outcomes."
The Portico valve is implanted using a catheter placed through a small incision in the femoral artery to restore normal blood flow to the heart and treat severe aortic stenosis.
It is the only approved transcatheter 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.
St Jude Medical cardiovascular and ablation technologies division president Frank J Callaghan said the Portico valve is an important part of company's growing portfolio of products that treat valvular disease and heart failure.
"The approval of this 25mm 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 said.
The Portico 23mm and 25mm transcatheter aortic heart valves continue to be evaluated in a non-randomised, multi-centre study, the Portico TF CE Trial.
The 23mm Portico transcatheter aortic heart valve received CE Mark in November 2012.
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 19mm to 27mm.
The Portico transcatheter aortic heart valve and transfemoral delivery system are not approved for use in the US.
According to GlobalData estimates, the transcatheter heart valves market in the US was valued at $280m in 2012 and is expected to grow at a CAGR of 25.3% to reach $1.36bn by 2019.
Image: St Jude secures CE Mark for its new 25 mm Portico transcatheter aortic heart. Photo: courtesy of St Jude Medical, Inc.