FDA approves first pulsed field AF ablation system
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Key takeaways:
- The FDA approved the first pulsed field ablation system for the treatment of paroxysmal and persistent AF.
- The approval is based on the positive results of the PULSED AF pivotal trial.
Medtronic announced the FDA approved its pulsed field ablation system for treatment of both paroxysmal and persistent atrial fibrillation via pulmonary vein isolation.
This is the first pulsed field ablation system (PulseSelect) to receive FDA approval, according to a company press release.
The approval is based on the results of the PULSED AF pivotal trial presented at the American College of Cardiology Scientific Session in March.
As Healio previously reported, AF ablation using electrical pulses demonstrated a low rate of adverse events and showed effectiveness consistent with established ablation strategies such as radiofrequency or cryoablation at 1 year.
The ablation system’s plug-and-play design allows it to be used with any mapping system or with just fluoroscopy, and built-in safety features such as a phrenic nerve test pulse provides a preemptive assessment of catheter proximity to the phrenic nerve prior to electrical pulse delivery, according to the release.
In addition to AF ablation, the nine electrodes can also be used for pacing and sensing, and its 9F bidirectional catheter is designed to improve maneuverability, according to the release.
"The PulseSelect PFA system ushers the EP community to a new era of safe, effective and efficient AF ablation that overcomes many challenges in our current practice," Amin Al-Ahmad, MD, clinical cardiac electrophysiologist at St. David's Medical Center in Austin, Texas, said in the release. "In my clinical experience with the catheter, it was designed for AF ablation procedures. The learning curve in using the catheter and system is short, and the catheter enables the operator to deliver fast and controlled pulsed field energy for AF ablation."
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