Dive Brief:
- Pulse Biosciences said Monday it plans to pursue premarket approval of its pulsed field ablation (PFA) device, delaying a program that was previously on the 510(k) pathway.
- The company filed for 510(k) clearance of its Cellfx cardiac clamp in January. However, the Food and Drug Administration requested human data, pushing Pulse to run a pivotal clinical trial.
- Cellfx has received breakthrough device designation. That status could accelerate parts of the process, but Needham analysts said the PFA device is now unlikely to come to market before late 2026, giving Atricure and Medtronic another two years without competition from Pulse.
Dive Insight:
Pulse has developed technology that delivers nanosecond-duration pulses of electrical energy to treat atrial fibrillation (AFib). While Boston Scientific and Medtronic are using catheters to deliver PFA, Pulse is focusing on the smaller opportunity for cardiac clamps used in AFib surgery. Pulse has estimated Atricure and Medtronic respectively accounted for 55% and 30% of the $250 million market in 2022.
The company claims PFA can improve on existing surgical thermal technologies by delivering faster ablation through thicker tissue. Needham analysts previously expected the device to come to market and pose a potential threat to Atricure as early as the second half of 2024.
Interactions with the FDA have reset the timeline. Darrin Uecker, chief technology officer at Pulse, said on an earnings call in March that the FDA sent an additional information letter, but the device was still in the 510(k) process at that time. On the next earnings call in May, Pulse CEO Kevin Danahy said the FDA wanted clinical data, but the 510(k) filing was still active. At the time, Pulse had only done preclinical studies in animals.
Two months later, Pulse has said it will no longer pursue clearance via the 510(k) pathway. Instead, the company plans to start a pivotal clinical trial in 2025 and seek premarket approval. Pulse will share more details of the regulatory and commercial implications later this year but Needham analysts have already speculated in a note to investors on what the change means for the surgical AFib market.
The Cellfx delay is positive for Atricure, the analysts said, because it removes a near-term threat to the open-heart ablation business, and gives it time to develop its own PFA clamp. Atricure CEO Michael Carrel mentioned the clamp on an earnings call in May without saying when it could launch.