Pulse Biosciences, a company with a primary focus on utilizing its innovative CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for treating atrial fibrillation, has officially submitted a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its new CellFX nsPFA Cardiac Clamp. Following the procedures outlined in Section 510(k), the FDA will conduct a comprehensive review, potentially requesting additional information during the process. According to FDA guidelines, the goal is to complete the 510(k) review within 90 calendar days, excluding the time required for the company to respond to any information requests, the duration of which will depend on the nature of the inquiries.

The submitted 510(k) includes comparative preclinical data highlighting the safety and performance advantages of nsPFA in cardiac ablation, showcasing potential benefits for both patients and physicians. The CellFX nsPFA Cardiac Clamp is designed for generating continuous linear transmural ablations during concurrent cardiac surgical procedures using the CellFX system. It utilizes the company's proprietary nsPFA technology, which is a nonthermal ablation approach. Preclinical data suggests that nsPFA may offer safety and performance benefits over current thermal ablation technologies, such as extreme heat or cold, in the context of cardiac ablation.

Positioned as a potential replacement for existing radiofrequency ablation devices, the CellFX nsPFA Cardiac Clamp holds promise, based on compelling preclinical data, to enhance adoption rates, boost procedural effectiveness, increase procedure volume, and find significant clinical application. A cardiac surgeon emphasizes the unique aspects of the clamp, including its speed and precision of delivery, consistent lesion quality across various tissue types or thicknesses, and an impressive safety profile, expressing anticipation for broader utilization among fellow professionals.

Source: businesswire.com

 

 

 

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