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Stock impact report

Pulse Biosciences Announces FDA IDE Approval to Initiate its nsPFA Cardiac Surgery System Study for the Treatment of Atrial Fibrillation

Pulse Biosciences, Inc (PLSE) 
Last pulse biosciences, inc earnings: 11/7 03:42 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.pulsebiosciences.com
Company Research Source: Business Wire
HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE)(the “Company” or “Pulse Biosciences”), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) technology, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company’s Investigational Device Exemption (IDE), allowing Pulse Biosciences to proceed with the initiation of its nsPFA Cardiac Surgery System Study, NANOCLAMP AF, for the treatment of atrial fibrillation (AF).This single-arm, prospective study is designed to demonstrate primary effectiveness of the nsPFA Cardiac Surgical System for the treatment of AF in concomitant surgical procedures. Up to twenty sites, including two outside the United States, are planned to enroll up to 136 patients. Additional details of the study will be made available on clinicaltrials.gov."We believe nsPFA’s novel and proprietary nonthermal mechanism of cardiac ablation offers signifi Show less Read more
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