SentreHeart said today it won CE Mark approval in the European Union for its Lariat surgical left atrial appendage suture delivery device used for soft tissue closure.
The device is commonly used for the ligation of the LAA as an adjunctive treatment to ablation in patients with persistent atrial fibrillation, the Redwood City, Calif.-based company said.
Closing off the LAA prevents blood clots from forming that could later cause stroke in AF patients.
“The Lariat surgical device solves many of the issues posed by current closure technologies in surgery. Improving the surgeon’s control, reducing operator variability and minimizing technique dependence through a simple to deliver, repeatable, suture-based solution is more natural for cardiac surgeons and should lead to better outcomes,” CEO Russell Seiber said in a press release.
The device allows operating physicians to perform complete ligations on soft tissue, including the LAA, by guiding a surgical snare over the tissue where an integrated suture-tightening tightens the pre-tied suture.
“The Lariat Surgical device is an elegant surgical closure solution, combining the best of all the current approaches into a single device. The new device enables flexibility in my approach and access to close tissue where I want, with the additional confidence that it will remain closed. These are important characteristics when closing soft tissue such as the left atrial appendage,” Dr. Krzysztof Bartus of Krakow, Poland’s Jagiellonian University said in prepared remarks.
In July, the FDA warned healthcare providers about the possibility of potentially deadly adverse effects from the Lariat anti-stroke device, saying a review of its adverse events database turned up 45 incidents involving Lariat, including 6 deaths.
The FDA said the reports from its Manufacturer & User Facility Device Experience database included complications from the Lariat procedures that included laceration and/or perforation of the heart, complete LAA detachment, hemorrhage, low blood pressure, pericardial and pleural effusion and cardiac tamponade.
Of the 45 events reported in the MAUDE database, 34 or roughly 75% required emergency heart surgery, the federal safety watchdog said. Healthcare providers should be aware “that the safety and effectiveness of the Lariat suture delivery device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established,” the FDA said.
In June, the agency approved an investigational device exemption for the Amaze clinical trial of the Lariat device.