St. Jude Medical Begins US Trial of Portico TAVR System

May 13, 2014—St. Jude Medical, Inc. announced that the first patient implants occurred in the PORTICO trial, the United States investigational device exemption trial of the company’s Portico resheathable transcatheter aortic valve system. The first implants in the PORTICO trial were conducted by teams at Cedars-Sinai Heart Institute in Los Angeles, California, and at Lenox Hill Hospital in New York City.

According to St. Jude Medical, the PORTICO trial is evaluating the safety and effectiveness of the Portico valve and delivery system in reducing the risk of death and disabling stroke in patients with symptomatic severe aortic stenosis who are high or extreme risk for open heart valve replacement surgery. The trial data will be used to support approval of the Portico system by the US Food and Drug Administration.

Patients at up to 40 sites in the United States will be randomized based on the appropriate access method, including transfemoral, transapical, direct aortic, or subclavian. All patients participating in the trial will undergo a TAVR procedure receiving either a Portico valve or another TAVR valve that is commercially available in the United States.

In addition to randomization, the PORTICO trial will also collect information in the form of a registry on patients with a degenerated aortic surgical bioprosthetic valve to create a valve-in-valve registry.

St. Jude Medical stated that the transcatheter Portico valve can be completely resheathed, repositioned at the implant site, or retrieved before being released from the delivery system. The self-expanding Portico valve is designed to maintain hemodynamics similar to that of a natural valve while also addressing issues from early generations of transcatheter valves, such as paravalvular leak and the need for a permanent pacemaker as a result of the implant. Portico is built upon the company’s surgically implanted Trifecta valve platform.

The 23-mm Portico transcatheter aortic heart valve and transfemoral delivery system received European CE Mark approval in 2012, and the 25-mm Portico valve received CE Mark approval in 2013. CE Mark clinical trials are currently underway for additional valve sizes and delivery approaches. The Portico transcatheter aortic heart valve system is limited to investigational use in the United States, advised St. Jude Medical.

At Cedars-Sinai, the Portico procedure team was led by interventional cardiologist Raj Makkar, MD, and cardiothoracic surgeon Wen Cheng, MD. The Lenox Hill team was led by cardiac surgeon Gregory P. Fontana, MD, and interventional cardiologist Carlos Ruiz, MD. Drs. Makkar and Fontana serve as Coprincipal Investigators for the PORTICO trial.

In St. Jude Medical’s press release, Dr. Fontana commented, “As we continue to collect clinical evidence on the best way to treat patients identified as high or at extreme risk for the open heart valve replacement procedure, the Portico valve represents a life-saving treatment option. The valve and delivery system were designed to more safely treat heart failure symptoms in patients with stenotic valves.”

Dr. Makkar added, “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.”