St. Jude Medical (NYSE:STJ), which paused implantations of its Portico replacement heart valve last fall out of an abundance of caution, told MassDevice.com today that European authorities reinstated Portico’s CE Mark.
The decision means St. Jude is resuming clinical and commercial implants of the Portico 23mm and 25mm transcatheter aortic valve implants in Europe, spokesman Justin Paquette told us via email.
"We remain in discussions with the FDA to gain approval to resume implants in our U.S. [investigational device exemption trial]," Paquette wrote.
Back in September 2014, St. Jude said CT scans turned up a potential problem with the valves in "a small number of cases," in which "reduced valve mobility" was seen in patients after 4D CT scans at 30 days.
But internal and external reviews of the valve "found no excess rate of clinical events associated with either Portico or control valves exhibiting the leaflet motion observation and patients with this leaflet motion observation were found to be asymptomatic," Paquette told us.
At the time there was speculation that the observation was due to "motion artifact" created by the imaging scan.
Paquette told us that St. Jude performed an "extensive review" of leaflet motion using CT scans and trans-esophageal echocardiography. The leaflet motion "was determined to be caused by the presence of a subclinical layer of thrombus," he wrote.
"The majority of patients analyzed had normal leaflet motion and patients with this leaflet motion observation were found to be asymptomatic," Paquette wrote.
STJ shares closed up 0.9% at $67.07 apiece today.
