Clinical Trial OutcomesThe ACURATE IDE trial did not meet its non-inferiority endpoint, with higher rates of all-cause mortality, stroke, or rehospitalization in the neo2 arm compared to the control arm.
Growth ConcernsThere is a belief that BSX's organic growth may have reached a near-term peak, and there is concern that investors may increasingly worry about BSX's growth slowing as it laps its outstanding 2024 results and new PFA competitors enter the market.
Regulatory ChallengesThe future of the neo2 valve in the United States is uncertain, and it likely requires another trial to gain market approval due to safety concerns.