Shots:
- Pulse Biosciences has received the US FDA IDE approval to initiate its NANOCLAMP AF study evaluating nsPFA system in ~136 pts with atrial fibrillation (AF) across 20 sites, incl. 2 outside the US
- The EU feasibility study of nsPFA Cardiac Clamp began in Aug 2024 with over 40 pts across 3 sites The Netherlands, showing ablations as fast as 2.5s & consistent, fully transmural lesions; additional sites will be added in 2025. nsPFA to be presented at EASTS’25
- nsPFA system delivers continuous, linear, transmural ablations during cardiac surgery using proprietary nonthermal nsPFA technology & minimizes the risk of collateral tissue damage; it received FDA’s BDD in Jul 2024 & is in the TPLC Advisory Program
Ref: Pulse Biosciences | Image: Pulse Biosciences | Press Release
Related News:- Airiver Medical Receives the US FDA’s IDE Approval to Study Airiver Pulmonary Drug Coated Balloon for Benign Central Airway Stenosis
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