- St. Jude Medical (NYSE:STJ) resumes its IDE trial assessing its Portico Transcatheter Aortic Valve Implantation (TAVI) system. The study is designed to support the company's regulatory approval application in the U.S. The estimated completion date is August 2019.
- Implantations were suspended in September 2014 due to reports that investigators observed reduced leaflet motion in the implanted valves in certain study participants. The observations were eventually found to be in the control arm, which consisted of commercially available TAVR (transcatheter aortic valve replacement) valves. The company and independent reviewers determined that reduced leaflet mobility is a class effect, present in TAVR and surgical valves across the industry. They found no excess rate of clinical events in patients implanted with Portico specific to leaflet motion. The data also show that reduced leaflet mobility is not linked to excess adverse events, has not been shown to negatively impact the clinical performance of the valves and can be resolved by medical therapy (usually the administration of anticoagulants).
- The Portico system was developed to simplify TAVR procedures for doctors by improving control, ease of use and accuracy compared to other TAVR products. The system also enables the valves to be fully recaptured and repositioned prior to full deployment and release from the delivery system to ensure optimal placement for the best patient outcomes. It was CE Mark-cleared in Europe in late 2012.