St. Jude puts Portico on hold

St. Jude Medical has hit the pause button on its Portico resheathable heart valve used in transcatheter aortic valve replacement (TAVR) procedures after reports of reduced leaflet mobility.

St. Jude received CE mark for its 25 mm valve in late 2013 as a treatment for high-risk patients with severe aortic stenosis. The 23 mm valve and delivery system won approval in Europe in 2012. The valve, which attaches to a self-expanding stent frame, can be repositioned at the implant site or retrieved prior to deployment.

The device is investigational only in the U.S., where a randomized, controlled clinical trial is under way for patients who are inoperable or at high risk. The U.S. Investigational Device Exemption (IDE) trial will evaluate the safety and effectiveness of the device.

“St. Jude Medical confirms that we have paused implanting all TAVR devices worldwide to allow the company time to evaluate recent cases of reduced valve leaflet mobility that were reported from a small number of CT scans performed approximately 30 days after implant in the U.S. IDE study,” according to a company statement.

St. Jude said it is contacting researchers, clinicians, its Data Safety Monitoring Board and regulators about the issue. “We are working as quickly as possible to complete our analysis that will help inform recommendations regarding patient care.”