Sam Brusco, Associate Editor12.14.23
Medtronic has gained U.S. Food and Drug Administration (FDA) approval for its PulseSelect pulsed field ablation (PFA) system to treat both paroxysmal and persistent atrial fibrillation (AFib). This marks the first FDA approval for PFA technology and follows the recent CE mark for PulseSelect PFA in November.
PulseSelect PFA offers rapid, effective pulmonary vein isolation (PVI) via consistent, predictable energy delivery and catheter maneuverability, Medtronic claims. Its safety, efficacy, and efficiency are supported by the PULSED AF study, which demonstrated 0.7% safety event rate and clinical success rates of 80% for both paroxysmal and persistent AF patients.
"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. It's a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients," said Rebecca Seidel, SVP and president of Medtronic’s Cardiac Ablation Solutions business. "The PulseSelect PFA system, together with the CE marked Affera mapping and ablation system and our strong Cryo platform, enables us to provide a broad portfolio of solutions to clinicians and their patients, all developed with years of research and supported by compelling scientific evidence."
PulseSelect was designed as a “plug-and-play” system that can be used with any mapping system or with only fluoroscopy. Its built-in safety features include a phrenic nerve test pulse, a non-therapeutic, low-voltage pulse that preemptively assess catheter proximity to the phrenic nerve before delivering a therapeutic application.
Fixed spacing for the system’s nine-electrode catheter produces a predictable, consistent electric field for contiguous ablation, and can be used for pacing and sensing as well.
PulseSelect PFA is the first FDA breakthrough-designation PFA technology to be approved. Medtronic expects commercialization to begin in early 2024.
PulseSelect PFA offers rapid, effective pulmonary vein isolation (PVI) via consistent, predictable energy delivery and catheter maneuverability, Medtronic claims. Its safety, efficacy, and efficiency are supported by the PULSED AF study, which demonstrated 0.7% safety event rate and clinical success rates of 80% for both paroxysmal and persistent AF patients.
"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. It's a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients," said Rebecca Seidel, SVP and president of Medtronic’s Cardiac Ablation Solutions business. "The PulseSelect PFA system, together with the CE marked Affera mapping and ablation system and our strong Cryo platform, enables us to provide a broad portfolio of solutions to clinicians and their patients, all developed with years of research and supported by compelling scientific evidence."
PulseSelect was designed as a “plug-and-play” system that can be used with any mapping system or with only fluoroscopy. Its built-in safety features include a phrenic nerve test pulse, a non-therapeutic, low-voltage pulse that preemptively assess catheter proximity to the phrenic nerve before delivering a therapeutic application.
Fixed spacing for the system’s nine-electrode catheter produces a predictable, consistent electric field for contiguous ablation, and can be used for pacing and sensing as well.
PulseSelect PFA is the first FDA breakthrough-designation PFA technology to be approved. Medtronic expects commercialization to begin in early 2024.