Last month St. Jude announced that it had completed the first implants in its PORTICO trial. The PORTICO trial is evaluating the device maker’s Portico Re-sheathable Transcatheter Aortic Valve System in patients with severe, symptomatic aortic stenosis.
Aortic stenosis is the narrowing of the aortic valve which impedes the flow of blood exiting the heart through the aorta. This narrowing is typically caused by a buildup of calcium deposits on the valve leaflets but can also be caused by rheumatic fever. Calcification of the valve leaflets tends to occur sooner in people born with abnormal aortic valves. During a transcatheter aortic valve replacement (TAVR) procedure, a valve is delivered to the heart via a catheter inserted into the femoral artery or another access site. This approach eliminates the need for open heart surgery and cardiopulmonary bypass.
The first implants in the PORTICO trial were conducted by two teams in the U.S., one at the Cedars-Sinai Heart Institute in Los Angeles and the other at Lenox Hill Hospital in New York. Dr. Mark Carlson, the Chief Medical Officer and V.P. of Global Clinical Affairs at St. Jude said “We have received positive feedback on the advanced features of the Portico valve from the experienced physicians who have used it. The Portico valve is an attractive option that will enable interventional cardiologists and cardiac surgeons who perform TAVR procedures to treat patients who might not otherwise be eligible for surgery”. The PORTICO Trial is estimated to conclude August of 2019. The trial is currently enrolling patients who are considered high risk and are not candidates for open heart surgery.
The Portico Re-sheathable Transcatheter Aortic Valve System is the TAVR system in which the valve is re-sheathable and repositionable until fully deployed.
Dr. Makkar, the Director of Interventional Cardiology at Cedars Sinai Heart Institute stated:
The ability to fully resheath and precisely reposition the Portico valve at the implant site prior to valve deployment helps achieve accurate placement, which may simplify the implant procedure and help minimize procedural risk for the patient.
If granted FDA approval, St. Jude will join 2 other manufacturers with a valve FDA approval for a transcatheter delivery. The two currently available are Medtronic’s CoreValve System and Edwards Lifesciences’ SAPIEN Valve. The Portico valve already has the CE mark of approval for its 23mm and 25mm sizes.