Shares of cardiac device maker AtriCure (NASDAQ:ATRC) jumped 20 percent after an FDA panel recommended approving one of the company’s device for the surgical treatment of atrial fibrillation.
AtriCure shares climbed the most in 16 months to around $12 in Thursday afternoon trading as enthusiastic investors reacted to positive news about the company’s Synergy ablation system from the U.S. Food and Drug Administration.
An FDA panel recommended that the agency approve the ablation system for the treatment of atrial fibrillation during open-heart surgeries, according to a statement from Cincinnati-area AtriCure. The FDA isn’t obligated to follow the panel’s advice, but it usually does.
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If the FDA approves the atrial fibrillation label for the ablation system, it would mark the first-ever surgical device to be approved for atrial fibrillation, a type of irregular heart rhythm. Approval would be a significant milestone for the company and make it a highly desirable acquisition target — if it isn’t already — to big device makers like Medtronic and St. Jude Medical.
The FDA is expected to make the final decision on the atrial fibrillation label by the middle of next year, AtriCure CFO Julie Piton said last month.
The device is already approved by the FDA for the ablation of heart tissue, but not for the treatment of atrial fibrillation.
Earlier this week, a report from FDA staffers noted some “concerns” with clinical trials of the device for the treatment of atrial fibrillation, but those concerns apparently weren’t enough to prevent the panel’s recommendation. News of the report sent AtriCure’s shares reeling, but Thursday’s gains made up for the tumble.
