St Jude Medical has treated the first patient with 25 mm Portico Transcatheter aortic heart valve using the transfemoral delivery system in its ongoing non-randomized, multi-center European trial.
Made of bovine pericardial tissue, the 25 mm Portico valve is attached to a self-expanding stent frame and 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.
The minimally invasive device can also be completely resheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site or retrieved before it is released from the delivery system, claims the company.
Portico TF EU study, which forms part of the company’s transcatheter valve program, will enroll up to 50 patient to demonstrate the safety and performance of the Portico 25 mm heart valve.
The company said it will use the trial data to further support CE mark approval.
In addition, the company is planing to start Portico valve’s US clinical trial, under the US Food and Drug Administration’s investigational device exemption, later in 2013.