Implantable Closure Device Blocks Vascular Thrombi

The Watchman LAA closure technology device is intended for patients who have nonvalvular atrial fibrillation (AF), and who require treatment to prevent potential thrombus formation. The basket-shaped device is composed of a very fine mesh basket made of nickel titanium (nitinol) with the atrial facing surface covered with a thin permeable polyester material. The device is designed to be permanently placed just behind or at the opening of the LLA, and is available in multiple sizes to accommodate the unique anatomy of each patient.

The Watchman device is constrained within a catheter until delivery in the LAA using standard procedures; once the catheter is in the approximate location, measurements are taken to ensure correct positioning; once confirmed, the device is released. Typical postoperative treatment is overnight hospitalization for observation, with recovery taking about 24 hours. The Watchman LLA device, developed by Atritech (Plymouth, MN, USA), is intended for investigational use in the Embolic Protection in Patients with Atrial Fibrillation (PROTECT AF) trial, which is evaluating the device as an alternative to the current standard of care, Warfarin, in patients with nonvalvular AF.

"The adoption of the Watchman technology in markets outside of the United States has been largely due to the compelling data contained in the Protect AF clinical trial,” said Jim Bullock, president and CEO of Atritech. "The initiation of a confirmatory study combined with the continued follow up of our study patients will further establish the clinical significance of this important technology.”

The left atrial appendage (LAA) has been identified as a major source of thrombi in patients with AF. Ligation of the LAA surgically is a procedure that has been carried out for many years, but is a very invasive technique, with limited data on benefits in patients at risk of AF related strokes.

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