St. Jude Obtains FDA Approval To Resume Evaluation Of Portico System

(RTTNews) - Medical devices maker St. Jude Medical Inc (STJ) on Wednesday it has obtained approval from the U.S. Food and Drug Administration to resume its U.S. IDE trial evaluating the Portico Transcatheter Aortic Valve Implantation System. The Portico IDE trial originally launched in May 2014, and is designed to support U.S. approval of the Portico system.

St. Jude said the approval follows a comprehensive review of the Portico system by the FDA after the company temporarily paused implants of the valve worldwide in September 2014.

The company decided to pause implants due to reports of reduced leaflet motion observations in patients implanted with Portico within the IDE study. The observation was subsequently identified in the study's control arm, which consisted of commercially-available TAVR valves.

A review by St. Jude found no excess rate of clinical events associated with the leaflet motion observation. Its findings were then confirmed by independent reviews, which found reduced leaflet mobility is a class effect, present in TAVR and surgical valves across the industry.

The data also confirmed that the observation is not linked to excess adverse clinical events, has not been shown to impact valve clinical performance and can be resolved by medical therapy.