Pulse Biosciences has announced a significant shift in its regulatory strategy for the Cellfx cardiac clamp, a pulsed field ablation (PFA) device initially being guided through the 510(k) pathway for clearance. The company initially filed for 510(k) clearance in January, but after the Food and Drug Administration (FDA) requested human data, Pulse has now decided to pursue premarket approval instead, which will involve conducting a pivotal clinical trial. This decision marks a delay in the device’s time-to-market, shifting it to potentially no earlier than late 2026.
The Cellfx device, which has received breakthrough device designation, uses electrical energy pulses of nanosecond duration to treat atrial fibrillation (AFib). Unlike Boston Scientific and Medtronic, which use catheters for PFA, Pulse’s approach involves cardiac clamps intended for use in AFib surgeries—a narrower segment of the market. In 2022, Pulse estimated the market size for this segment to be around $250 million, with Atricure and Medtronic holding significant market shares of 55% and 30%, respectively.
Pulse’s technology is claimed to offer advantages over existing thermal ablation techniques traditionally used in surgery, including the ability to deliver faster ablation through thicker tissue. Prior to the recent regulatory developments, analysts from Needham had projected that the device could enter the market and compete with Atricure as early as the second half of 2024. This expectation set the stage for a potentially disrupted market dynamic.
However, the timeline was reset following the FDA’s engagement, which culminated in a request for clinical data. This interaction initially emerged in March when Pulse’s Chief Technology Officer, Darrin Uecker, mentioned receiving an additional information letter from the FDA but noted that the device was still in the 510(k) process at that point. By May, Pulse CEO Kevin Danahy confirmed the need for clinical data while stating that the 510(k) filing was still active, despite only preclinical animal studies having been conducted up to that time.
In a decisive strategic shift, two months after these discussions, Pulse announced it would abandon the 510(k) pathway and aim for premarket approval following a pivotal trial scheduled to start in 2025. Further regulatory and commercial details surrounding this decision are expected to be shared by the company later in the year.
From a competitive standpoint, this delay in bringing Cellfx to market is viewed as a positive development for Atricure. Analysts highlighted that the absence of Pulse’s new device in the near-term marketplace alleviates imminent competitive pressures on Atricure’s open-heart ablation business. This delay grants Atricure additional time to further develop and potentially launch its own PFA clamp, an initiative mentioned by Atricure’s CEO, Michael Carrel, during an earnings call in May, though specifics regarding the timeline were not disclosed.
In summary, Pulse Biosciences’ shift from seeking 510(k) clearance to aiming for premarket approval reflects a significant setback in terms of the planned market entry timeline for its Cellfx cardiac clamp. While this regulatory pivot might delay Pulse’s ambitions, it strategically benefits its competitors, particularly Atricure, by deferring the introduction of a potentially disruptive technology in the surgical AFib treatment market until at least late 2027. The market dynamics and development efforts in this niche area of cardiac surgery will likely continue to evolve as these companies work toward advancing their respective technologies under the changing regulatory landscapes.
#Pulse #drops #510k #plan #PFA #device #FDA #requests #clinical #data
