St Jude Medical has reported 10 patient feasibility study data of its Portico Transcatheter Aortic Heart Valve.
The 23 mm Portico valve is constructed with a bovine pericardial tissue and is designed to increase physicians’ control and placement accuracy during valve deployment.
Portico valve can be delivered through two methods including transfemoral (delivered via the femoral artery) and transapical (delivered via a small incision in the apex of the left ventricle).
The company said the Portico transcatheter heart valve can be completely resheathed (the process of bringing the valve back into the delivery catheter), which aids physicians to reposition the valve at the implant site or retrieve the valve, before it is released from the delivery system.
The aim of the study was to determine the device deployment characteristics device safety, technical feasibility of the Portico Valve and transfemoral delivery system.
The study followed for 30 days demonstrated no device or procedure-related adverse events or death and majority of patients had trivial or no paravalvular leak after 30 days.
The company concluded that the European clinical trial for the Portico transcatheter aortic valve is expected to start before the end of 2011.