AtriCure Inc. (NASDAQ: ATRC) has received regulatory clearance to begin U.S. sales of its AtriClip device, which protects against blood clots during certain heart procedures.
The news sent AtriCure’s stock soaring 17 percent to $6.13 in early after-hours trading.
The company plans an initial launch of the device later this month, with a full commercial release coming in the third quarter, according to a statement from West Chester, Ohio-based AtriCure.
The device’s full name is the AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion System. It is named after Cleveland Clinic Chief Executive Officer Dr. Delos “Toby” Cosgrove and Clinic Dr. A. Marc Gillinov, who helped pioneer the practice of using a clip to block a thumb-sized pouch on top of the left side of the heart to cut down on blood clots that could lead to strokes for patients who have atrial fibrillation.
CEO David Drachman called receiving Food and Drug Administration clearance of the device — known in the industry as 510(k) clearance — “a major product and clinical milestone” for the company. AtriCure received European clearance, known as the CE Mark, to sell the device in October.
Drachman wasn’t overstating the significance of 510(k) clearance to the company. AtriCure has tied a large portion of the company’s future success to the AtriClip. AtriCure estimates the U.S. market opportunity for the device at $300 million.
Last year, AtriCure got FDA approval to sell Cryo1, a disposable medical device that uses extreme cold to ablate the heart. Since the device was cleared, the company has captured 20 percent of the surgical cryothermia products market, Drachman said in May.