AtriCure (NSDQ:ATRC) shares got a modest bump today after revealing pre-market approval from the FDA for its Synergy radiofrequency ablation system for atrial fibrillation.
ATRC shares were up 2.1% to $10.86 as of about 1 p.m. today.
The approval covers treatment of patients with "persistent and long-standing persistent AF during open-heart concomitant coronary artery bypass grafting and/or valve replacement or repair procedures, according to a press release.
It’s the first surgical ablation system approved by the federal watchdog agency for treating AF (other, catheter-based techniques have already gotten an FDA nod) and the first-ever approved for treating persistent and long-standing persistent AF, according to AtriCure. The FDA already cleared the Synergy device for cardiac ablation during concomitant open-heart surgical procedures.
The agency’s approval for the new indication mandates a 350-patient post-approval study, which already has 46 patients enrolled, as well as a training program for docs using the system, AtriCure said.
"This marks the achievement of a major milestone for AtriCure, the field of cardiac surgery, and the treatment of AF. The approval confirms the effectiveness of the Synergy Ablation System and recognizes the increasing need for the surgical treatment of AF," president & CEO David Drachman said in prepared remarks. "We look forward to educating physicians and patients on our surgical alternative for the treatment of AF, which we believe will raise awareness for a large number of AF patients that are currently being under-treated. Importantly, we would like to thank all of our partners who worked with us to achieve this approval, particularly the FDA, physicians and their patients who participated in the ABLATE trial. Additionally, I would like to recognize the efforts of the AtriCure team, who have worked tirelessly toward the successful achievement of this seminal milestone."