St. Jude Medical Receives FDA Approval to Resume Evaluation of the Portico System

June 4, 2015—St. Jude Medical, Inc. announced the resumption of the company’s United States trial conducting under an investigational device exemption (IDE) that is evaluating the Portico transcatheter aortic valve replacement (TAVR) system. The approval follows a comprehensive review of the Portico system by the US Food and Drug Administration (FDA) after St. Jude Medical temporarily paused implantations of the valve worldwide in September 2014.

According to the company, the Portico IDE trial was originally launched in May 2014 to support FDA approval of the Portico system. The company decided to pause implantations because of 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.

St. Jude Medical stated that its review found no excess rate of clinical events associated with the leaflet motion observation. These 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.

Raj Makkar, MD, who is a Coprincipal Investigator for the Portico US IDE trial, commented in the company’s press release, “I’m very proud to work alongside a team of investigators that partnered with St. Jude Medical to prioritize patient safety and support the industry’s current understanding of leaflet motion observations relative to transcatheter and surgical valves. I’m excited to be able to resume our IDE study and advance the evaluation of the Portico valve in the United States.” Dr. Makkar is Director of Interventional Cardiology at Cedars-Sinai Heart Institute in Los Angeles, California.