September 17, 2014 — St. Jude Medical is asking surgeons worldwide to “pause” implanting the Portico TAVR, an aortic heart valve replacement device, due to safety concerns about valve leaflets that are not as mobile as they should be, according to the Star Tribune.
St. Jude has stopped clinical trials of the device worldwide. The Portico TAVR is on the market in Europe and other countries, but it is only in investigational-device-exemption (IDE) trials in the United States. All studies have been paused.
St. Jude has not issued a public statement, but told Heartwire:
“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 US IDE study.”
The Portico TAVR is a transcatheter aortic-valve replacement. The device is designed to prop open narrowed aortic valves, which helps improve blood-flow out of the heart.
Normally, open heart surgery is necessary to treat a narrow aortic valve. The advantage of the Portico TAVR is that it can be implanted with a minimally-invasive catheter procedure, usually through a large artery in the leg.
Many device-makers are racing to dominate the TAVR market. The implants are currently only approved in patients who are too sick for open-heart surgery, but manufacturers hope they will ultimately be approved for a much wider patient population. Unfortunately, because the devices are so new, no one knows how they will perform in the long run. Traditional aortic valve replacements are known to last 15-20 years.