St. Jude Medical Resumes Portico Trial
St. Jude Medical will resume its U.S. investigational device exemption trial evaluating the Portico transcatheter aortic valve implantation system, the St. Paul, Minn., devicemaker announced Wednesday.
The trial launched in May 2014, but was paused in September after reports surfaced of reduced leaflet motion observations in study patients. The FDA oversaw a comprehensive review, which identified the leaflet motion as coming from the control arm, patients implanted with commercially available TAVR systems.
St. Jude’s findings, confirmed by independent reviewers, found that leaflet motion was a class effect that occurs in TAVR and surgical valves throughout the industry. The findings also demonstrated that the issue is not linked to adverse events, did not affect valve performance and can be fixed by medical therapy. As such, the FDA reauthorized clinical trial approval.
In the Western world, aortic stenosis is the third most common form of cardiovascular disease after hypertension and coronary artery disease. TAVR procedures are used for at-risk patients who are unable to undergo open heart surgery. — Jason Scott