SentreHEART Receives 510k Approval for the LARIAT XT Suture Delivery Device

REDWOOD CITY, Calif. SentreHEART, Inc. announced that it has received 510k approval for the LARIAT^® XT, the latest in a family of soft tissue closure devices, designed to offer remote suture delivery for immediate, complete closure, with no metal, clip or implant left behind. The LARIAT XT incorporates a variety of enhancements, including a fully retractable snare designed to facilitate ease-of-operator use and potentially expand its applicable anatomic range.

The LARIAT XT offers precise, user controlled remote delivery of a pre-tied suture loop that is compatible with a wide range of anatomical shapes and sizes up to 45mm in width.

The Lariat XT will compliment the Lariat+, currently being used in the recently FDA IDE approved aMAZE study, which is intended to demonstrate that a LARIAT procedure for LAA closure, plus a subsequent PVI ablation will lead to a reduced incidence of recurrent AFib compared to PVI alone; with a high safety profile. The study plans to enroll a maximum of 600 persistent or longstanding persistent patients who are candidates for PVI catheter ablation at up to 50 centers.

Source: SentreHEART