AtriCure Inc. (NSDQ:ATRC) won 510(k) clearance from the Food & Drug Administration for its AtriClip device, which protects against blood clots during heart procedures.
The news sent AtriCure’s stock soaring 17 percent, to $6.13, in early after-hours trading June 14.
The West Chester, Ohio-based company plans an initial launch of the device later this month, with a full commercial release coming in the third quarter, according to a press release.
The device’s full name is the AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion System. It is named after Cleveland Clinic CEO Dr. Toby Cosgrove and the clinic’s 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 in patients with atrial fibrillation.
AtriCure CEO David Drachman said winning the clearance is “a major product and clinical milestone” for the company. AtriCure received CE Mark approval in the European Union in October.
Drachman wasn’t overstating the significance of 510(k) clearance for the company. AtriCure has tied a large portion of the company’s future success to the AtriClip and estimates the U.S. market opportunity for the device at $300 million.
Last year, AtriCure won FDA approval to sell Cryo1, a disposable medical device that uses extreme cold to ablate the heart. Since receiving that clearance, the company has captured 20 percent of the surgical cryothermia products market, Drachman said in May.