AtriCure competitor clamp unlikely to launch until 2026 or later, says Needham

Needham notes that Pulse Biosciences (PLSE) announced that it received FDA Breakthrough Device Designation for its surgical ablation clamp using pulsed field ablation, or PFA, and plans to pursue a premarket approval for the clamp, which will require a clinical study. This is a change from its prior plans to market the clamp with a 510(k) clearance, says the analyst, who thinks it is unlikely to receive FDA approval until late 2026 or later and believes that this is positive for AtriCure (ATRC). The later-than-anticipated potential launch eliminates a potential near-term competitive threat to AtriCure’s U.S. Open-Heart Ablation business and provides the company with time to pursue its own PFA clamp, added the analyst, who maintains a Buy rating and $40 price target on AtriCure shares.