First Pulsed Field Ablation Catheter Approved for Afib

Derick Alison
Derick Alison
4 Min Read

The FDA approved the first pulsed field ablation (PFA) catheter, the PulseSelect PFA system, for the treatment of paroxysmal and persistent atrial fibrillation (Afib), Medtronic announced on Wednesday.

Whereas conventional radiofrequency ablation and cryoablation create scar tissue in the heart via thermal damage to isolate aberrant electrical pathways and restore sinus rhythm, PFA uses microsecond-scale, high-voltage electrical fields to damage cell membranes and thus induce tissue necrosis to isolate the pulmonary veins for the treatment of Afib.

The hope has been that PFA, with its non-thermal mechanism of cell death, would reduce the risk of unintended damage to nearby collateral structures, lessening esophageal or phrenic nerve injury.

Approval for the PulseSelect device was based on the multicenter, single-arm PULSED AF trial, which included 150 patients with paroxysmal symptomatic Afib and another 150 patients with persistent symptomatic Afib who were refractory to class I or III antiarrhythmic drugs.

Afib ablation with the PulseSelect device met the primary endpoint of freedom from a composite of acute procedural failure, arrhythmia recurrence, or need for antiarrhythmic escalation through 12 months. Rates were 66.2% in paroxysmal Afib and 55.1% in persistent Afib compared with the performance goal of 50%.

The procedure had a clinical success rate of 80% in paroxysmal Afib and 81% in persistent Afib and showed a 0.7% rate of serious procedure- and device-related adverse events. No cases of pulmonary vein stenosis, phrenic nerve injury, or esophageal injury occurred.

“As the first PFA catheter to receive FDA approval, the PulseSelect catheter is ushering in a new era of ablation,” Vivek Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital in New York City, told MedPage Today. “Overall, I think PFA will be a big win for patients, and I for one am looking at these developments with anticipation.”

Aside from potential safety benefits, the approach has signaled advantages for procedural workflow in a number of European studies, as well as a few U.S. studies, said Reddy, who has been involved in trials with other ablation and PFA catheters in development.

He pointed to a wide array of PFA catheters passing through pivotal trials in the U.S., including the Farapulse PFA system in the ADVENT trial, the Sphere-9 ablation and mapping catheter in the SPHERE Per-AF trial, the Varipulse device in the AdmIRE trial, and the Globe system in the PULSAR trial.

“Based on these trials (and others that are soon to commence), I expect to see a steady cadence of new PFA catheters approved over the next several years,” Reddy said.

Medtronic noted that features of the PulseSelect system include a nine-electrode catheter with fixed spacing that can also be used for pacing and sensing, capacity for use with any mapping system or with fluoroscopy, and a phrenic nerve safety feature that delivers a non-therapeutic, low-voltage pulse to assess catheter proximity to the phrenic nerve prior to delivering a therapeutic application.

The company said it expected the PulseSelect system to be commercially available in early 2024.

Disclosures

Reddy disclosed serving as a consultant to Medtronic and numerous other medical device companies working in the PFA space.

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