Portico TAVR Heart Device Implants Halted Over Safety Concerns

Portico-TAVR-Heart-Device-Implants-HaltedDevice maker St. Jude Medical has halted implantation of the Portico transcatheter aortic valve replacement (TAVR) over safety concerns that surfaced in U.S. clinical trials.

The Portico TAVR device is intended for patients with severe aortic stenosis (narrowing) who are at high risk for open-heart valve replacement surgery or who cannot have surgery. In an email to Medscape, the company confirmed that it had halted implantation worldwide while evaluating “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 [investigational device exemption] study.”

The device is already available internationally in sizes 23F and 25F, and has received CE marking, a legal requirement needed for a device to be placed on the market in the European Union. The Portico TAVR is available in the U.S. only through clinical trials. All implantations have been stopped, including those involving trials of other sizes of the device, Medscape reports.

St. Jude Medical says its device stands out from similar devices, including the Medtronic CoreValve and the Edwards Sapien XT, because its device can be brought back into the delivery catheter, repositioned or retrieved as needed, according to Fierce Medical Devices. At this month’s Transcatheter Cardiovascular Therapeutics cardiology conference in Washington DC, St. Jude presented study data that “indicates that the Portico valve is performing well at 12 months and is producing sustained improvements in patient outcomes,” according to Medscape.

The company is in the process of communicating the decision to study investigators, clinicians, and regulatory authorities in the U.S., and to countries in Europe where the device is already available commercially.

 

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