PulseSelect is the first PFA technology approved for use in the U.S., as well as the first PFA technology with FDA breakthrough designation to win approval.
The minimally invasive, cardiac ablation system is indicated for the treatment of paroxysmal and persistent atrial fibrillation (AFIb).
Medtronic said it will start commercialization in early 2024.
“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,” Medtronic SVP and Cardiac Ablation Solutions President Rebecca Seidel said in a news release. “It’s a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients.”
“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,” she continued.
Medical Design & Outsourcing: How Medtronic designed the PulseSelect pulsed field ablation system for AFib
Medtronic said its PULSED AF study demonstrated clinical success rates of 80% in both paroxysmal and persistent AFib patients, with only a 0.7% safety event rate.
Pulsed-field ablation is a non-thermal method for cardiac ablation to treat AFib, delivering energy for pulmonary vein isolation while reducing the risk of damage to surrounding structures.
The nine electrodes on the Medtronic PulseSelect system’s catheter generate an electric field for contiguous ablation. Those electrodes can also be used for pacing and sensing.
PulseSelect is designed for use with fluoroscopy only or any mapping system.
Medical Design & Outsourcing: What’s so special about pulsed field ablation? Medtronic SVP Sean Salmon explains
The Medtronic PFA system beat the competing Boston Scientific Farapulse PFA system to FDA approval. Farapulse also has FDA breakthrough device designation. Boston Scientific has previously said it expects Farapulse approval sometime in 2024 and reported positive data on the system last month. Company officials outlined their excitement for the PFA system at an Investor Day event in September.
Watch for more PFA news from Medtronic on its Affera system, which some analysts thought might win FDA approval before PulseSelect.
Medical Design & Outsourcing: Why Affera’s cardiac ablation technology is worth $1B to Medtronic
