Question · Q4 2025
Matt Taylor asked about the potential range of outcomes for the Champion trial, specifically if there's a chance of showing superiority on any endpoints, and whether a positive Champion result could boost concomitant procedures in the Option indication.
Answer
CMO Kenneth Stein clarified that the Champion trial's bleeding endpoint is powered for superiority, while the stroke endpoint aims for non-inferiority (as effective as drugs). He believes demonstrating superiority on bleeding, similar to the Option trial, is crucial. He also stated that a positive Champion result would strengthen the current Watchman indication, including Option, and provide increased impetus for referrals, while also sustaining Watchman growth over the long-range plan by developing a new indication.
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