Cardiac device company AtriCure (NASDAQ:ATRC) has closed a feasibility clinical trial into a so-called “hybrid” procedure to treat atrial fibrillation, citing a change of plans in the study’s protocol.
Cincinnati-area AtriCure’s DEEP AF feasibility study was investigating the hybrid procedure, which received that name because it combines catheter ablation, which occurs inside the heart, with a minimally invasive ablation procedure that creates lesions on the outside of the heart.
The change in plans involves when the two major portions of the hybrid procedure are performed. Rather than perform each part of the procedure in a single session, AtriCure will now focus on a “staged approach” in which each portion is scheduled separately.
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AtriCure said a staged approach would lessen the learning curve related to the hybrid procedure for clinicians. Additionally, the staged approach would alleviate some scheduling and logistical challenges, AtriCure CEO David Drachman said.
AtriCure enrolled 24 of an expected 30 patients in the trial before closing it.
For AtriCure, the change in plans creates some uncertainty around the future regulatory path associated with the procedure. (Successful trials could lead to AtriCure receiving approval from the U.S. Food and Drug Administration to label its bipolar ablation system for the treatment of atrial fibrillation.)
Drachman said it was unclear whether the FDA would require the company to design and conduct a new feasibility study of the procedure before proceeding to a pivotal trial. Also unclear is the length of time the FDA will require patients to wait between undergoing the two parts of the procedure in the new, staged approach.
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“We still have to talk to the agency and get their view,” Drachman said on a conference call with analysts.
AtriCure had planned to launch a 35-center pivotal trial next year, which Drachman had said would be an “inflection point” for the company. Now, the arrival of that “inflection point” will be delayed, at the very least.
Still, Drachman put a positive spin on the news, noting that “we accomplished our objective of gaining a better understanding of the procedure prior to proceeding to a pivotal trial.”
AtriCure’s shares were up less than 1 percent in early trading, indicating that the market isn’t particularly concerned about the company’s change in plans.
