St. Jude Medical Announces First Implants in U.S. Study of the Portico Transcatheter Aortic Heart Valve

May 20, 2014 — St. Jude Medical Inc. announced that the first patient implants occurred in the Portico Re-sheathable Transcatheter Aortic Valve System U.S. IDE Trial (PORTICO trial). The clinical trial is evaluating the Portico transcatheter aortic valve system, the first aortic heart valve that is repositionable until fully deployed. The trial will enroll patients who are considered to have a high or an extreme surgical risk (meaning they would not be considered) for open-heart surgery.

The PORTICO trial is evaluating the Portico valve and delivery system in patients with symptomatic severe aortic stenosis. During transcatheter aortic valve replacement (TAVR) procedures, a Portico heart valve is delivered via a catheter using either a transfemoral or an alternative access approach in order to gain access to the heart. The Portico valve is positioned in the patient’s heart as it continues to beat, alleviating the need for cardiopulmonary bypass, where a machine takes over a patient’s heart and lung function. Patients are evaluated by a heart team consisting of a cardiac surgeon and an interventional cardiologist.

The first implants in the PORTICO trial were conducted the same day on opposite coasts of the United States. One operating team comprised of Raj Makkar, director of interventional cardiology, and Wen Cheng, cardiothoracic surgeon and program director of the thoracic surgery residency program performed a Portico TAVR procedure at Cedars-Sinai Heart Institute in Los Angeles. The other operating team was comprised of Gregory P. Fontana, cardiac surgeon and chairman of the department of cardiothoracic surgery and Carlos Ruiz, an interventional cardiologist at Lenox Hill Hospital in New York City. Fontana and Makkar serve as co-principal investigators for the PORTICO trial.

“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,” said Fontana.

“The ability to fully re-sheath 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,” said Makkar.

For more information: www. SJMPortico.com