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US FDA approves Medtronic’s system for heart condition

2023.12.14 11:02


© Reuters. FILE PHOTO: Medtronic Plc logo is seen displayed in this illustration taken, April 10, 2023. REUTERS/Dado Ruvic/Illustration/File Photo

(Reuters) -Medtronic said on Wednesday that the U.S. Food and Drug Administration (FDA) had approved its system for a type of condition that can cause stroke or heart failure.

The system, PulseSelect Pulsed Field Ablation (PFA), is used for the treatment of atrial fibrillation (AF), a condition that is characterized by an irregular rhythm of the heart.

PFA is used for ablation procedures that treat AF using small burns or freezes to cause some scarring on the inside of the heart to help break up the electrical signals that cause irregular heartbeats.

Commercialization of the PFA system will start in early 2024, the company said.

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