Boston Scientific (BSX) said Saturday a trial of the Watchman FLX left atrial appendage closure device met all its primary and secondary safety and efficacy endpoints.
The study evaluated the device versus non-vitamin K antagonist oral anticoagulants as a first-line option for stroke risk reduction in patients with non-valvular atrial fibrillation, a heart rhythm disorder.
Results showed that the device provided "statistically superior" protection from bleeding and demonstrated similar efficacy compared with blood thinners, the company said.