Fierce Biotech December 14, 2023
Medtronic has secured the first FDA green light for a pulsed field ablation system, bringing a new type of atrial fibrillation treatment to the U.S.
By using short bursts of specifically tuned electric energy, pulsed field ablation disrupts certain types of cells more than others without generating excess heat. In cardiac ablation, that means taking aim at the cells in the heart muscle that cause irregular heartbeats—while sparing nearby tissues, such as the esophagus, from the damage that may come from the traditionally more indiscriminate methods of thermal ablation.
The FDA’s approval for the company’s PulseSelect system—for isolating the pulmonary vein in patients with intermittent or persistent afib—follows a previous breakthrough designation from the agency. It also comes shortly...
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