St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the first patient implants occurred in the Portico ™ Re-sheathable Transcatheter Aortic Valve System U.S. IDE Trial (PORTICO trial). The 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(TM) Transcatheter Aortic Heart Valve is being evaluated in a clinical study. Caution: Investigational device. Limited by Federal (or United States) law to investigational use. Photo provided by St. Jude Medical.
The PORTICO trial is evaluating the Portico valve and delivery system in patients with symptomatic severe aortic stenosis – a narrowing of the aortic valve that significantly impedes blood from flowing out of the heart. During transcatheter aortic valve replacement (TAVR) procedures, a Portico heart valve is delivered via a catheter using either a transfemoral (through the artery in the leg) 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 U.S. One operating team comprised of Dr. Raj Makkar, director of Interventional Cardiology, and Dr. 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 Dr. Gregory P. Fontana, cardiac surgeon and chairman of the department of cardiothoracic surgery and Dr. Carlos Ruiz, an interventional cardiologist at Lenox Hill Hospital in New York City. Drs. Fontana and Makkar serve as co-principal investigators for the PORTICO trial.