St. Jude Medical (NYSE:STJ) hit the worldwide "pause" button on implantations of its Portico transcatheter aortic valve implant, including in a U.S. trial and in Europe, where the replacement heart valve is already on the market.
St. Jude spokeswoman Candace Steele Flippin told MassDevice.com today that the company initiated the pause after CT scans turned up a potential problem with the valves in "a small number of cases." The issue, involving what Steele Flippin called "reduced valve leaflet mobility," was seen in patients after 4D CT scans at 30 days.
St. Jude is in the process of reviewing the 4D CT scans on the patients in its U.S. pivotal trial whose earlier scans turned up the potential problem, Steele Flippin said during a telephone interview.
"We’re still trying to understand what exactly the scans are showing. We’re conducting a very comprehensive analysis," Steele Flippin said, noting that the company is moving as fast as it can with its evaluation. "In cases such as this patient safety is our highest priority."
Results from clinical trials of the Portico valve show that the device functions within the normal range for TAVI devices and shows normal adverse event rates, including 12-month data from 1 of the trials presented at the annual Transcatheter Cardiovascular Therapeutics conference in Washington, she emphasized.
"We are also in the process of communicating with study investigators, clinicians, the data safety monitoring board, and appropriate regulatory authorities. St. Jude Medical is committed to the highest levels of device performance and transparency," Steele Flippin wrote via email. In a telephone interview she stressed that the 4D CT scans, which are a new imaging modality, are not part of the U.S. pivotal trial’s protocol and were undertaken by 1 of the study’s investigators in "a small number" of cases, but declined to reveal how many cases are involved.
The issue is whether the problem is a "motion artifact" created by the imaging scan or an actual problem with the Portico valves’ function, according to physicians that Leerink Swann analyst Danielle Antalffy talked to at the TCT conference in Washington. Antalffy believes the problem is most likely related to motion artifact, she wrote in a note to investors today.
Either outcome likely means a delay for the pivotal trial, although the delay will be longer if the problem isn’t just an imaging glitch; Steele Flippin declined to specify how long the delay might be because the company’s evaluation of the potential problem is ongoing.
"Our sense is that Portico patients have not had unusually negative outcomes – particularly OUS where the valve has been available for several years now – which would imply that the 2nd scenario is most likely," Antalffy wrote.
The news pushed STJ shares down 0.9% to $62.49 apiece as of about 11:20 a.m. Eastern today. The stock dropped 2.7% to a $63.08 close Sept. 12 after the company revealed the problem.