MINNEAPOLIS — Medtronic made history with a new device aimed at treating conditions that cause uncontrollable or irregular heartbeats.
The company announced that its PulseSelect Pulsed Field Ablation became the first technology of its kind to get approval by the United States Food and Drug Administration.
"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's President of the Cardia Ablation Solutions business Rebecca Seidel said in a release. "It's a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients."
According to Medtronic, PulseSelect is used to treat both paroxysmal and persistent atrial fibrillation (AF), which impacts more than 60 million people worldwide. AF can become worse over time and can increase the risk of serious complications, including heart failure, stroke and increased risk of disease.
PulseSelect had a 0.7% safety event rate, according to Medtronic, and clinical success rates of 80% in both paroxysmal and persistent AF.
"Every patient deserves the best care," said Khaldoun Tarakji, Chief Medical Officer of Medtronic's Cardiac Ablation Solutions business. "What motivates all of us at Medtronic is the privilege of serving patients by empowering electrophysiologists globally with the safest and most effective ablation technologies that seamlessly integrate with their workflows and enable them to tailor therapy based on their patients' needs."
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