St. Jude Medical (NYSE:STJ), which paused implantations of its Portico replacement heart valve last fall out of an abundance of caution, won the FDA’s approval to resume U.S. implants of the device in a clinical trial, the company said yesterday.
Back in September 2014, St. Jude said CT scans turned up a potential problem with the Portico valves in “a small number of cases,” in which “reduced valve mobility” was seen in patients after 4D CT scans at 30 days. Portico is a transcatheter aortic valve implant designed to treat aortic stenosis. European authorities reinstated Portico’s CE Mark in March.
Yesterday St. Jude said the FDA based its call on a comprehensive review of the device, including St. Jude’s own examination and independent evaluations, which found the problem to be "a class effect, present in TAVI 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," the company said.
"We are excited to resume our U.S. [investigational device exemption] trial, which is a critical step toward providing the Portico valve to more patients in need," chief medical officer Dr. Mark Carlson said in prepared remarks. "We have been encouraged by the clinical results and the response of physicians to the Portico valve in Europe and other geographies. We look forward to continuing to partner with physicians in the U.S. to further evaluate the benefits of the Portico system."
"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," added co-principal investigator Dr. Raj Makkar of the Cedars-Sinai Heart Institute in Los Angeles. "I’m excited to be able to resume our IDE study and advance the evaluation of the Portico valve in the U.S."