St. Jude Medical Reports Positive Results In Portico Transfemoral CE Trial

(RTTNews) - St. Jude Medical, Inc. (STJ) announced the positive results for the 23 and 25 mm Portico Transcatheter Aortic Heart Valves in the Portico Transfemoral CE Mark Trial or Portico TF CE Trial. The company said that the patients enrolled in the study experienced a significant improvement in valve function at 30 days.

The preliminary findings indicate exceptional hemodynamic performance and improvement in the severity of heart failure symptoms as measured by the New York Heart Association Functional Classification System.

The data was presented today at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium, sponsored by the Cardiovascular Research Foundation.

During transfemoral delivery, the Portico valve is implanted through a small incision in the femoral artery. The procedure uses a catheter to deliver and position the valve in the heart while it continues to beat. This avoids placing the patient on cardiopulmonary bypass, where a machine takes over heart and lung function during surgery.

Image of the 23 mm Portico Transcatheter Aortic Heart Valve, one of two valves being evaluated in the Portico Transfemoral CE Mark Trial. The Portico valve and transfemoral delivery system are not approved for use in the U.S., the company specified.

The non-randomized, multi-center Portico TF CE Trial was initiated to evaluate the Portico 23 mm transcatheter heart valve, which received CE Mark in November 2012, and was later expanded to include the Portico 25 mm valve. Clinical results for the 25 mm Portico valve are currently under regulatory review to support European CE Mark approval.

The Portico valve is the first transcatheter aortic heart valve that can be completely resheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site or retrieved before being released from the delivery system.