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AtriCure Update On DEEP AF Feasibility Trial - Call Transcript

Stocks in this article: ATRC

AtriCure’s results may differ materially from those discussed on today’s call and AtriCure undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

I would like to remind everyone on the call today that the Food and Drug Administration, or FDA, has not cleared our products for the treatment of atrial fibrillation, or AF, or for stroke reduction. The company and others acting on its behalf may not promote any of its products or train doctors for the surgical treatment of AF or stroke reduction.

These restrictions do not prevent doctors from choosing to use the products for the treatment of AF or stroke reduction or prevent AtriCure from engaging in sales and marketing efforts that focus only on the general attributes of the products for the current cleared uses. AtriCure educates and trains doctors in the proper use of its products and related technologies.

With that, I would like to turn the call back to Dave.

David Drachman

Good morning. We announced this morning that we have closed enrollment in the current DEEP AF feasibility study in order to redesign the protocol. I will give you some additional background regarding that decision and following my remarks, we will have a question and answer period.

The decision to close enrollment in the DEEP AF study was reached by AtriCure following a recent investigators meeting. This investigators meeting coincided with a meeting of the Data Safety and Monitoring Board, also known as the DSMB.

The DSMB was convened to review the safety results for the trial that had been reported in the 24 patients enrolled to date. At the investigators meeting, the primary discussion points included the opportunities and challenges of performing the hybrid ablation procedure in a single session versus a staged hybrid approach.

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