USA — The US FDA has granted approval to Medtronic for its PulseSelect Pulsed Field Ablation (PFA) System, marking a significant leap in the treatment of paroxysmal and persistent atrial fibrillation (AFib).
This approval makes PulseSelect the first PFA technology to be sanctioned for use in the U.S., and notably, it is also the first PFA technology to secure FDA breakthrough designation.
The minimally invasive cardiac ablation system offers a revolutionary approach to the treatment of AFib, addressing both paroxysmal and persistent cases. Medtronic has announced plans to initiate commercialization of PulseSelect in early 2024.
Rebecca Seidel, Senior Vice President and President of Cardiac Ablation Solutions at Medtronic, expressed the groundbreaking nature of this achievement, stating, “Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency.”
PulseSelect is anticipated to redefine safety standards for AF ablation while providing a high level of efficacy and efficiency, aligning with Medtronic’s vision of delivering disruptive electrophysiology solutions for patients.
The system, in conjunction with the CE Marked Affera mapping and ablation system and Medtronic’s Cryo platform, aims to offer a comprehensive portfolio of solutions backed by years of research and robust scientific evidence.
Clinical success rates demonstrated in Medtronic’s PULSED AF study are promising, with an impressive 80% success rate observed in both paroxysmal and persistent AFib patients, coupled with a minimal 0.7% safety event rate.
Pulsed-field ablation, employed by PulseSelect, stands out as a non-thermal method for cardiac ablation in treating AFib.
This innovative technology delivers energy for pulmonary vein isolation while mitigating the risk of damage to surrounding structures.
The nine electrodes on the PulseSelect system’s catheter generate an electric field for contiguous ablation and can be used for pacing and sensing, enhancing the versatility of the system.
Medtronic’s successful FDA approval of PulseSelect comes as it competes with Boston Scientific’s Farapulse PFA system, which also holds FDA breakthrough device designation.
While Farapulse is expected to gain approval in 2024, the Medtronic PulseSelect system has clinched the title of being the first FDA-approved PFA technology.
The competitive landscape involves divergent opinions among analysts, with BTIG analysts praising PulseSelect’s safety profile, highlighting strengths such as zero esophageal complications, absence of pulmonary valve stenosis, and no reported evidence of phrenic nerve injury.
However, J.P. Morgan analyst Robbie Marcus favors Affera and Boston Scientific’s Farapulse, suggesting they have a slight edge in terms of efficacy and usability.
This development builds on Medtronic’s strategic moves in the PFA space, with the acquisition of Affera, a company that secured a CE mark for its focal catheter alternative to Boston Scientific’s single-shot approach.
PulseSelect adds a single-shot challenger to Farapulse, allowing Medtronic to diversify its offerings and cater to varying preferences within the medical community.
The FDA approval follows closely on the heels of PulseSelect obtaining the CE Mark about one month ago, setting the stage for potential global adoption.
The European market, where physicians now have the choice between three PFA devices, serves as a prelude to the anticipated competition for market share in the U.S. in the coming year.