Boston Scientific’s Ekos System Supported by Data From KNOCOUT PE Registry

October 5, 2021—Boston Scientific announced results from the KNOCOUT PE registry, which was established to measure institutional adoption of a lower dose and lower-duration thrombolysis protocol for the company’s EkoSonic endovascular system (Ekos system).

Using ultrasound technology, the Ekos system is designed to accelerate thrombolysis, minimizing the time it takes to treat a patient and lowering the necessary thrombolytic dose, which can result in optimized outcomes and a lower risk of bleeding.

The KNOCOUT PE data confirmed the safety and efficacy of the Ekos system for the treatment of patients with intermediate-high and high-risk pulmonary embolism (PE), stated Boston Scientific.

Keith M. Sterling, MD, the study’s Principal Investigator, presented the findings during a late-breaking clinical trials session at the VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada.

According to Boston Scientific, the international registry of 489 patients across 83 centers included data from patients treated with the Ekos system who were provided a lower drug dose and shorter infusion duration of a thrombolytic agent than administered in previous studies, reflecting contemporary clinical practice.

The data demonstrated that there were no intracerebral hemorrhagic events with a low major bleeding rate of 2.5%, compared to the rate previously observed with systemic thrombolysis treatment. Results also demonstrated a 23% postprocedure reduction in the main indicator of heart strain from PE, measured as right ventricular to left ventricular diameter ratio.

“PE remains a life-threatening and complex disease, but these results provide an opportunity to advance patient care by showcasing evidence that proves a lower drug dose and shorter infusion duration of a thrombolytic agent may result in enhanced safety and efficacy,” commented Dr. Sterling in the company’s press release. “The findings in this registry analysis are very reassuring to physicians making critical evidence-based decisions for their patients in what are oftentimes emergent treatment situations.”