FDA approves several radiofrequency AF ablation catheters for use without fluoroscopy
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Key takeaways:
- Several Biosense Webster AF ablation products received FDA approval for use without fluoroscopy.
- Use of alternative imaging modalities reduces radiation exposure.
Biosense Webster announced several of its products in its cardiac ablation portfolio have received FDA approval for use without fluoroscopy.
Alternative imaging guidance, such as ultrasound, may be used alongside the products (Thermocool Smarttouch SF catheter, Thermocool Smarttouch catheter, Carto Vizigo Bi-Directional guiding sheath, Pentaray Nav Eco High Density Mapping Catheter, Decanav Mapping Catheters and Webster CS Catheter), reducing radiation exposure, according to a company press release.
The approval of the label change was based on an analysis of the REAL AF Registry that evaluated real-world catheter ablation clinical outcomes among patients with paroxysmal AF who underwent radiofrequency ablation.
“Cardiac ablation procedures for the treatment of atrial fibrillation (AFib) usually require fluoroscopy to guide the advancement and positioning of intracardiac catheters, resulting in considerable radiation exposure for patients, operators and support medical staff as well as a high orthopedic burden from protective equipment such as lead aprons,” Jose Osorio, MD, FHRS, president of Heart Rhythm Clinical and Research Solutions, said in the release. “Eliminating or reducing radiation exposure is beneficial to patients as well as physicians and staff working every day in the electrophysiology lab.”
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