Boston Scientific (BSX) said Saturday that a global clinical trial demonstrated its Ekos blood clot device, combined with anticoagulants, outperformed standard treatments for patients with intermediate-risk pulmonary embolisms.
The study met its primary endpoint by reducing associated mortality and severe respiratory failure events by 61% within seven days compared to using blood thinners alone, the company said.
Patients treated with the targeted ultrasound system experienced a 4% overall complication rate versus 10.3% in the control group without any instances of brain bleeding over 30 days, Boston Scientific said.
The research enrolled 544 participants from both the US and Europe, with patient monitoring scheduled to continue for one year following the procedure, it added.