What is pulsed field ablation?
Pulsed field ablation (PFA) is a nonthermal ablative modality that uses a short-living, strong electrical field created around a catheter to create microscopic pores in cell membranes (electroporation).
When adequately dosed or configured it shows a preference for myocardial tissue necrosis. Thus, it holds a promise to become a perfect energy source for cardiac ablation to treat arrhythmias.
Clinical trial results, FDA approvals*, capital requirements, and reimbursement considerations all culminate in a complex landscape.
We are closely monitoring the progress of PFA and the suppliers who are racing to market. In the coming months, we will update this page with articles, podcasts and webinars to help healthcare providers gain insight into how these important changes may impact future care pathways for cardiac patients, to share best practices when adopting the new technology, and to explore strategic considerations when partnering with medical device suppliers in this dynamic environment.
*The status of FDA approval should be confirmed prior to engaging in a commitment agreement for capital or disposables. CFR21.812.7 prohibits suppliers from promoting or marketing a device until after FDA has approved it for commercial distribution.
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NOTE: there are no FDA-approved PFA systems currently.
The benefits associated with PFA over current ablation modalities include tissue selectivity and reduced procedure times.
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