No Longer Accepting Cases

September 17, 2014 — Heartwire reports that St. Jude Medical has “paused” all implantations of a heart valve replacement device because of safety concerns.

The product is the Portico TAVR (transcatheter aortic-valve replacement), a device that is implanted in patients with severe narrowing of the aortic valve that impedes blood from flowing out of the heart.

St. Jude has not issued a public statement, but they told Heartwire that the problem is related to the leaflets on the valve:

“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 leaflets that flex to produce blood flow to the aorta had less mobility than was expected, according to the Star Tribune.

Open-heart surgery is usually necessary to fix a narrow aortic valve. The advantage of the Portico TAVR is that it is inserted via a catheter, usually through an artery in the leg. Currently the procedure is restricted to patients who are most likely to die during open-heart surgery, but device-makers are hoping the minimally-invasive procedure will be approved for a wider patient market.

The first implants in the United States have been conducted in an investigational-device-exemption (IDE) trial. The product is not yet available on the commercial market in the United States, but it is being marketed in Europe and other countries. All studies and implantations worldwide have been paused.

The problem with the TAVR is that it is a relatively new device and the long-term risks are unknown. Traditional aortic valves have a lifespan of about 15-20 years, but no one knows how long the newer catheter-delivered TAVRs will last.