Medtronic's PulseSelect PFA System Gets FDA Nod, Revolutionizing Atrial Fibrillation Treatment in US
Portfolio Pulse from Vandana Singh
The FDA has approved Medtronic plc's PulseSelect Pulsed Field Ablation (PFA) System for treating atrial fibrillation (AF), marking it as the first PFA technology approved in the U.S. and the first with FDA breakthrough designation following its recent CE Mark in Europe. Medtronic's PULSED AF study showed an 80% clinical success rate with a low safety event rate. The PulseSelect system features nine electrodes for contiguous ablation and can be used with fluoroscopy or any mapping system. Commercialization is set for early 2024. Medtronic's stock (MDT) rose 1.20% in premarket trading.
December 14, 2023 | 12:39 pm
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POSITIVE IMPACT
Medtronic's PulseSelect PFA System received FDA approval, indicating a positive outlook for the company's cardiac treatment portfolio. The stock saw a premarket increase of 1.20%, reflecting investor optimism.
The FDA approval of Medtronic's PulseSelect PFA System is a significant milestone for the company, likely to boost investor confidence and potentially increase the stock price in the short term. The premarket stock price movement suggests immediate positive investor reaction. The approval also strengthens Medtronic's position in the cardiac treatment market, which could have favorable implications for future revenue and growth.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100