Boston Scientific of Marlborough has won federal regulatory approval for an implantable medical device that helps patients at high risk for stroke, the company said.
The product, the Watchman Left Atrial Appendage Closure Device, was approved by the U.S. Food and Drug Administration (FDA). It will be made available to sites in the United States where Boston Scientific (BSX) is conducting clinical studies, BSX said. It will also be available in additional, specialized centers as doctors are trained on how to implant the device.
The Watchman is indicated to reduce the risk of thromboembolism from the left atrial appendage in some patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on the results of certain tests, BSX said.
