Europe’s granting of the CE Mark for the AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion System means the company can move ahead as planned with a product roll out in Europe that will last through the rest of this year. The device attaches to the heart to keep blood from flowing into the left atrial appendage, a lower portion of the heart, during treatments to stop rapid heart beat (atrial fibrillation).
AtriCure had tied a large portion of the company’s future success to the AtriClip. The company thinks the device can help reinvigorate sagging minimally invasive products revenues. The AtriClip can be used for several heart procedures and executives told investors they envision the AtriClip eventually becoming a separate business within the company. AtriCure estimates the U.S. market opportunity for the device at $300 million.
AtriCure has enrolled 70 patients in a U.S. clinical trial for the AtriClip and will submit a device approval application to the U.S. Food and Drug Administration by year’s end. AtriCure hopes to launch the AtriClip in the United States by the middle of next year.
AtriCure stock was down about 1.5 percent by mid-afternoon Tuesday.