As part of St Jude Medical’s ongoing European trial, the first patient has been implanted with the 25mm Portico transcatheter aortic valve implantation (TAVI) device using the transfemoral delivery system.
According to a company press release, the Portico Transfemoral European Trial (Portico TF EU Trial) was established to evaluate the 23mm Portico valve, which recently received European approval, and has been expanded to include the 25mm Portico valve.
A non-randomised, multicentre study—the Portico TF EU trial—will evaluate the safety and performance of the Portico 25mm valve in patients with severe aortic stenosis. The trial will enrol up to 50 patients across Europe. Data from the study will be used to support CE mark approval.
The press release reported that expanding the Portico TF EU trial to include the 25mm Portico valve size will allow physicians to increase their research of the technology in patients whose anatomy requires a larger valve size.
Made of bovine pericardial tissue, the Portico valve is attached to a self-expanding stent frame. 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.
“The start of the Portico TF EU Trial for the 25mm Portico valve is another major milestone in our transcatheter valve program and an indication of our commitment to provide new options to patients suffering from aortic valvular heart disease,” said Frank J Callaghan, president of the Cardiovascular and Ablation Technologies Division at St Jude Medical.
The Portico valve and transfemoral delivery system are not yet approved for use in the USA. A US clinical trial evaluating the Portico valve is expected to start later this year. The trial will be conducted under a FDA Investigational Device Exemption (IDE).