Pulse Biosciences, a leading medical technology company based in Hayward, California, has just achieved a major milestone in its quest to revolutionize the treatment of atrial fibrillation (AFib). The company announced today that the FDA has granted breakthrough device designation for its cutting-edge pulsed field ablation system.
Breakthrough Device Designation Granted
This designation is specifically for Pulse Biosciences' Cardiac Surgery System, which is designed to ablate cardiac tissue for the treatment of AFib. The system, featuring a surgical clamp powered by the company's proprietary nanosecond pulsed field ablation (nsPFA) technology, is capable of creating durable, continuous transmural ablation lesions during cardiac surgery.
Faster and Safer Treatment
According to preclinical studies, a single application of the nsPFA technology takes less than two seconds to create a consistent, transmural ablation. This is a significant improvement over current thermal ablation technologies, as it is 20 times faster and eliminates the risk of thermal damage to surrounding tissues.
Path to Commercialization
Pulse Biosciences is now set to pursue premarket approval to commercialize its nsPFA Cardiac Surgical System in the United States. The company also has plans to initiate an AFib pivotal clinical trial in 2025, aiming to further demonstrate the effectiveness and safety of its innovative technology.
Exciting Milestone
President and CEO of Pulse Biosciences, Burke T. Barrett, expressed his enthusiasm about the FDA's decision, stating, "The breakthrough device designation granted by the FDA is an exciting milestone for Pulse. It emphasizes the unique potential benefits of nanosecond PFA. We plan to fully leverage the benefits of this designation and have chosen to seek PMA approval to achieve a specific indication for the treatment of atrial fibrillation. We look forward to aligning with the FDA on a pivotal clinical trial design in the near-term and towards initiating our planned first-in-human cases in the Netherlands soon."
In conclusion, Pulse Biosciences' breakthrough in AFib treatment technology marks a significant advancement in the field of cardiac surgery, offering a faster and safer alternative to existing ablation methods. With the FDA's recognition and support, the company is poised to make a substantial impact on the lives of patients suffering from AFib.