Medical device maker AtriCure Inc. said regulators cleared its AtriClip system, which is designed for use in surgery treating atrial fibrillation.
The Food and Drug Administration cleared AtriCure's AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion system. The system is intended for use during treatment of atrial fibrillation, a condition in which the upper chambers of the heart beat rapidly and ineffectively. AtriClip is designed to block the left atrial appendage, a small sac attached to the upper left chamber of the heart.
During atrial fibrillation, blood can pool inside the left atrial appendage, causing blood clots that can get into the blood stream and move to other parts of the body.
The approval allows AtriCure to market the device for use in open heart surgeries.
AtriCure announced the approval after the market closed on Monday, and its shares surged in Tuesday morning trading, rising $1.47, or 28 percent, to $6.70. Earlier they rose 38 percent to $7.20, their highest price since October 2008.