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.
During the staged hybrid procedure, the minimally invasive surgical ablation is performed first and catheter optimization is scheduled separately. In addition, the investigators discussed recruiting new sites for a pivotal trial and a review of the initial clinical results.The scheduling and logistics aspects of performing the hybrid procedure in the same session can present certain challenges. Although three of the five investigational sites were advocating to continue with the same-session procedure, all the investigators agreed that during the learning curve period, having the surgeon perform the minimally invasive procedure in their operating room and having the electrophysiologist perform their catheter optimization procedure in their EP lab may reproduce and lessen complications and alleviate the logistical challenges of integrating this procedure into certain new investigational sites. In terms of safety, a report of the adverse events was presented to the investigators and the results were considered acceptable by the investigators given that the patients are subject to the cumulative risk of a minimally invasive surgical procedure as well as a catheter based procedure and that the treatment options for the study population are limited. A total of seven primary adverse events, including one stroke occurring on postoperative day 27, resulting in death on day 30, were reported to the investigators and discussed interactively throughout the meeting. No adverse events were attributed to the investigational device. Importantly, the investigators recommended that we continue to discussions with FDA concerning the need for including a severity index into the clinical protocol in order to more accurately assess the risk-benefit profile of this investigational procedure and system. In the interim, it was recommended that adverse events should be further graded as mild, moderate, or severe. In addition, the independent physician adjudicator presented a report to the DSMB and characterized all of the events as mild or moderate, except for the aforementioned stroke and subsequent death.
The cause of the stroke could not be determined, and was unknown, and therefore it was given attribution to the procedure. Consistent with the charter of the DSMB, when a death occurs, the board recommends the study enrollment be suspended until an independent physician adjudicator can be obtained and further discussion can occur with the board.Read the rest of this transcript for free on seekingalpha.com