SentreHeart said today that it won CE Mark approval for its Lariat-RS 50mm and expanded labeling for the device for left atrial appendage exclusion.
The Redwood City, Calif.-based company touted that its Lariat-RS device is different from other percutaneous LAA devices in Europe as it is the only non-implant solution for complete and permanent exclusion of the LAA.
The Lariat device is designed to allow physicians to deliver a pre-tied suture loop to the base of the LAA from the outside, and leaves no metal or foreign material inside the heart. The company said that over time, the LAA will disappear and no longer be a source for blood clots in patients with atrial fibrillation.
SentreHeart said that it is currently engaged in a prospective, multi-center, randomized controlled trial at 65 U.S. centers exploring the effectiveness of the Lariat procedure for LAA closure in adjunct with subsequent pulmonary vein isolation catheter ablation procedures to reduce the incidence of recurrent AF compared to PVI for patients with drug-refractory, persistent and long-standing AF, according to a press release.