Pulse Biosciences Reports IDE Approval To Initiate NsPFA Cardiac Surgery System Study

(RTTNews) - Pulse Biosciences (PLSE) announced that the FDA has granted approval for the Investigational Device Exemption, allowing Pulse Biosciences to proceed with the initiation of its nsPFA Cardiac Surgery System Study, NANOCLAMP AF, for the treatment of atrial fibrillation. The nsPFA Cardiac Surgical System received FDA Breakthrough Device Designation in July 2024 and is enrolled in the FDA's Total Product Life Cycle Advisory Program.

The company's first-in-human feasibility study has been underway in the EU since August 2024, with over 40 patients treated across three sites in The Netherlands.

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