St Jude Medical has announced that its 25mm transcatheter aortic valve implantation (TAVI) Portico device has received the CE mark. The company states that the approval means that Portico system can now be used in more patients.
A company press release reports that, 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. It adds that the 25mm valve supports a patient’s native annulus with diameters ranging from 21mm to 23mm, and the CE mark approval means that the Portico platform can now treat patients with an annulus ranging from 19mm to 23mm. 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 addition of the 25mm Portico valve broadens the patient population that can now be treated with this family of valves,” says Gerhard Schuler, head of the department of Internal Medicine/Cardiology at the University of Leipzig in Leipzig Germany.
According to the press release, the Portico 23mm and 25mm transcatheter aortic heart valves continue to be evaluated in a non-randomised, multicentre study (the Portico TF CE Trial). Data from this study was recently presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Results highlighted the 23mm and 25mm Portico valves’ haemodynamic performance and improvement in the severity of patients’ heart failure symptoms as measured by the New York Heart Association (NYHA) functional classification system. The 23mm Portico TAVI device received the CE mark last year.