Late last year, an ablation system from cardiology device maker AtriCure (NASDAQ:ATRC) became the first device to secure U.S. Food and Drug Administration clearance for the surgical treatment of atrial fibrillation.
Now, the Cincinnati-area company’s attention will turn to training surgeons to perform atrial fibrillation procedures using its device, the Synergy Ablation System.
CEO David Drachman said in a conference call with analysts on the company’s fourth-quarter results that AtriCure’s “highest strategic priority is accelerating U.S. growth.” Training surgeons to use the Synergy system to treat atrial fibrillation (AF), the most common type of irregular heart rhythm, will be a critical factor in determining whether the company achieves the growth it’s aiming for.
It’s easy to see why growing its U.S. business is important to AtriCure. In the fourth quarter, its U.S. revenue dropped 5 percent compared to the prior year. Contrast that with international revenue, which grew nearly 32 percent during that same period.
As a condition of FDA approval of the AF label, AtriCure will train and certify existing users of the Synergy ablation system within 18 months, and train new users prior to their purchase of the system, Drachman said.
To help support its training plans, AtriCure has reorganized its sales organization into nine regional rhythm management teams. “The aim of our sales realignment is to support our training initiatives and monitor the effectiveness of our training investments,” Drachman said.
Another condition of FDA approval was that AtriCure conduct a post-approval study assessing the safety and efficacy of using the Synergy ablation system in a procedure to treat persistent AF. The post-approval study will enroll and treat 350 patients at a maximum of 50 sites, Drachman said.