St. Jude Medical, Inc., a global medical device company, announced the feasibility study results for the companys Porticoâ„ Transcatheter Aortic Heart Valve, presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
The results presented by Dr Ganesh Manoharan were part of a 10 patient feasibility study conducted at the Royal Victoria Hospital in Belfast, Northern Ireland. The objectives of the study were to determine the technical feasibility, safety and device deployment characteristics of the 23 mm Portico Transcatheter Aortic Heart Valve and transfemoral delivery system.
At 30 days, study results showed no device or procedure-related adverse events or death. Significantly, the results also demonstrated that a majority of patients had trivial or no paravalvular leak after 30 days. In heart valve replacement procedures, paravalvular leaktypically results from a small opening around the outside of the valve.
Based on our experience implanting the valve and the positive patient outcomes we have seen in these 10 patients, the Portico transcatheter valve technology looks very promising, said Dr. Manoharan. The St. Jude Medical valve is proving to truly be a next-generation technology. Having the ability to resheath and reposition the valve allowed for accurate valve placement, which “ combined with the valves open cell stent design “ likely contributed to the impressive results.
The Portico valve, which is made of bovine pericardial tissue, is designed to increase physicians’ control and placement accuracy during valve deployment. The Portico transcatheter heart valve can be completely resheathed (the process of bringing the valve back into the delivery catheter) allowing physicians to reposition the valve at the implant site or retrieve the valve, before it is released from the delivery system.
During the feasibility study, the valve was successfully resheathed twice. No patients in the study required implantation of a pacemaker, there were no clinical strokes, no vascular complications and no additional valves were implanted during the same procedure.
The St. Jude Medical Portico transcatheter heart valve was designed for the estimated 400,000 patients with severe aortic stenosis who are considered to be high risk or inoperable for conventional open-heart valve replacement therapy. Two delivery methods will be available for the Portico valve, transfemoral (delivered via the femoral artery) and transapical (delivered via a small incision in the apex of the left ventricle).
The European clinical trial for the Portico transcatheter aortic valve is expected to start before the end of 2011.