St Jude Medical reports positive outcomes from heart valve clinical trial

31 October 2013

St. Jude Medical has announced positive results for its 23 and 25 mm Portico Transcatheter aortic heart valves in the Portico Transfemoral CE Mark Trial (Portico TF CE Trial).

Results from the trial showed patients enrolled in the study experienced a significant improvement in valve function at 30 days. The preliminary findings indicate exceptional hemodynamic performance (the ability to maximize blood flow) and improvement in the severity of heart failure symptoms as measured by the New York Heart Association (NYHA) Functional Classification System.

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

Dr Ganesh Manoharan of Royal Victoria Hospital in Belfast, U.K. presented preliminary data on the Portico 23 and 25 mm valves from 83 patients diagnosed with severe aortic stenosis, a narrowing of the aortic valve that obstructs blood flow from the heart. These patients are candidates for a transcatheter aortic valve replacement (TAVR) procedure, as many are considered high-risk for conventional open-heart valve replacement surgery.

“The data presented today demonstrates the benefits of the Portico Transcatheter Aortic Heart Valve in treating sick and critically ill patients with symptomatic aortic stenosis, who simply cannot withstand the rigors of a surgical heart valve replacement procedure,” said Dr. Manoharan, lead principal investigator in the Portico TF CE Trial. “The Portico valve’s self-expanding stent design and ability to be repositioned prior to deployment helps ensure precise valve placement, potentially improving patient outcomes and reducing the likelihood of complications such as a post-procedural pacemaker.”

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.