May 7, 2015 — The safety of several snare-like devices used in heart surgery are under scrutiny following a recall of the TigerPaw System II and a concerning study of the Lariat Left Atrial Appendage (LAA) closure device.
The FDA issued a Class I recall for the TigerPaw System II after receiving 51 reports of adverse events and one death. The agency warned about the risk of life-threatening bleeding and tearing of the left atrial wall due to incomplete closure of the fastener.
The LAA is a sac in the heart that is believed to be a source of blood clots that cause strokes in patients with atrial fibrillation. Closure of the LAA is supposed to help prevent strokes.
Study Questions Safety of Lariat LAA Closure Device
Unfortunately, the TigerPaw is not the only LAA closure device under scrutiny. The Lariat LAA closure device was linked to serious risks in a study published by JAMA Internal Medicine earlier this week.
Researchers looked at data on 309 patients who were treated with the device, and found that 2.3% required emergency heart surgery. One patient died.
The Lariat is widely-used “off-label” for LAA closure, but was never approved by the FDA for this purpose or tested in clinical trials. It was approved under the 510(k) process, which allows new devices on the market without requiring new studies so long as it is similar to another device.
According to Heartwire, the Lariat appears to have been specifically designed for use in the heart. The manufacturer also emphasizes the word “heart” in the name. However, when the FDA approved the Lariat, they did not have any data supporting its use as an LAA closure device.