Hayward, California–based Pulse Biosciences’ technology utilizes its CellFX nanosecond pulsed field ablation (nsPFA) technology and percutaneous electrode system, which the FDA cleared earlier this year. It enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures.
The FDA granted the breakthrough nod for the company’s Cardiac Surgery System for ablating cardiac tissue to treat AFib. This system, which features a surgical clamp, produces durable, continuous transmural ablation lesions during cardiac surgery. The bipolar clamp utilizes the proprietary nsPFA technology.