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| St. Jude's Portico transcatheter aortic heart valve--Courtesy of St. Jude |
St. Jude Medical ($STJ) has halted implantation of its Portico transcatheter aortic valve replacement (TAVR) due to concerns about reduced valve leaflet mobility arising from the company's U.S. clinical trials. The CE-marked device is intended for patients with severe aortic stenosis who are at high risk or contraindicated for surgical aortic valve replacement.
"St. Jude Medical confirms that we have paused implanting all TAVR devices worldwide to allow the company time to evaluate recent cases of reduced valve leaflet mobility that were reported from a small number of CT scans performed approximately 30 days after implant in the U.S. IDE study," the company said in an email to Medscape.
While the device is available internationally in sizes 23F and 25F, it is only available through clinical trials in the U.S. All implantations have been stopped, including those involving trials of other sizes of the device, Medscape reports.
"Patient safety is our highest priority, so we have made the thoughtful and deliberate decision to stop implanting Portico devices until we complete our comprehensive analysis," the company said in an email to Medscape. "We are also in the process of communicating with study investigators, clinicians, the data safety monitoring board, and appropriate regulatory authorities. St. Jude Medical is committed to the highest levels of device performance and transparency."
The CE mark was received in November 2012. St. Jude claims the product stands out from the field including Medtronic's ($MDT) CoreValve and Edwards' ($EW) Sapien XT because it can be brought back into the delivery catheter, repositioned or retrieved as needed.
In May, the company completed its first Portico implant in the U.S. in hopes of securing FDA approval. St. Jude said data presented at the ongoing TCT cardiology conference in Washington, DC, "indicates that the Portico valve is performing well at 12 months and is producing sustained improvements in patient outcomes." But it looks like the trial has raised safety concerns instead.
- read the Medscape article (reg. req.)
- here's the product website