Pulse Biosciences received FDA approval for their Investigational Device Exemption (IDE) to conduct a study on the nsPFA Cardiac Surgery System for treating atrial fibrillation.
The study aims to demonstrate the effectiveness of the nonthermal nsPFA technology in cardiac ablation procedures.
The approval marks a significant milestone for Pulse Biosciences in advancing their novel cardiac surgical approach.
Innovative Technology
nsPFA offers significant safety, effectiveness, and speed improvements over current thermal modalities like radiofrequency ablation.
Conducting IDE Study
Pulse Biosciences plans to enroll up to 136 patients in the nsPFA Cardiac Surgery System Study at multiple sites, including international locations.
Breakthrough Device Designation
The FDA granted Breakthrough Device Designation to the nsPFA Cardiac Surgical System, recognizing its potential clinical value and benefits in cardiac ablation procedures.
- The FDA IDE approval paves the way for Pulse Biosciences to establish the efficacy of their nsPFA technology in treating atrial fibrillation through clinical trials.
- The innovative nsPFA Cardiac Clamp aims to offer a safer and more efficient alternative to traditional radiofrequency ablation devices, potentially revolutionizing cardiac ablation procedures.
- Pulse Biosciences' ongoing feasibility study in Europe has shown promising results, including rapid ablation times and consistent lesion creation, building a strong foundation for future global adoption.
With FDA approval to initiate the IDE study for the nsPFA Cardiac Surgery System, Pulse Biosciences is poised to make significant advancements in cardiac ablation technology, offering a potential breakthrough in treating atrial fibrillation.