Pulse Biosciences launches first-in-human pulsed field ablation trial [Yahoo! Finance]
Pulse Biosciences, Inc (PLSE)
Last pulse biosciences, inc earnings: 11/7 03:42 pm
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Source: Yahoo! Finance
The two patients were treated at St Antonius Hospital in the Netherlands, initiating the first-in-human feasibility study. The patients tolerated the procedure well, said Pulse's chief medical officer of cardiac surgery Gan Dunnington. The multi-centre study will enrol up to 30 patients, featuring an endocardial catheter-based remapping to confirm chronic isolation at approximately three months post-treatment. The company's Cardiac Surgery System received US Food and Drug Administration (FDA) breakthrough device designation last month. The system uses Pulse's CellFX nanosecond pulsed field ablation (nsPFA) technology and percutaneous electrode system, which secured FDA clearance in March 2024. It facilitates the ablation of soft tissue in both percutaneous and intraoperative surgical procedures. The system comes equipped with a surgical clamp which enables durable continuous transmural ablation lesions during cardiac surgery. Pulse said it plans to use the clinical data from
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