WASHINGTON, DC — St Jude Medical has issued a "pause" on all implantations of its Portico transcatheter valve worldwide, heartwire has confirmed.
The company is in the process of communicating its decision to operators in Europe and other countries where the device is already available commercially in the 23F and 25F sizes, as well as study investigators in the US currently implanting the device as part of the US investigational-device-exemption (IDE) trial. Other studies are also ongoing, investigating the newer sizes of the device—these, too, have been paused, company spokesperson Justin Paquette told heartwire .
"St Jude Medical confirms that we have paused implanting all [transcatheter aortic-valve replacement] 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 US IDE study," the company said in an email.
No public statement had yet been issued at the time of publication, and a display with the Portico device in the TCT 2014 exhibit hall has no mention of the pause on implants, although the woman speaking with attendees who stopped by the display told heartwire she can answer questions about the company’s decision, if asked.
"We are working as quickly as possible to complete our analysis that will help inform recommendations regarding patient care," the statement to heartwire reads. "Patient safety is our highest priority, so we have made the thoughtful and deliberate decision to stop implanting Portico devices until we complete our comprehensive analysis. 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."
Paquette pointed out to heartwire that 12-month data presented by Dr Ganesh Manoharan here at TCT 2014 "indicates that the Portico valve is performing well at 12 months and is producing sustained improvements in patient outcomes. To date, the worldwide TAVR adverse-event rates remain low and are consistent with event rates cited in the literature."
Cite this: St Jude Issues Worldwide 'Pause' on Portico TAVR Implants - Medscape - Sep 14, 2014.