Boston Scientific presents data from REAL-PE study of EKOS at TCT

Data from the REAL-PE study was presented at Transcatheter Cardiovascular Therapeutics, or TCT, demonstrating that patients treated for pulmonary embolism, or PE, with the Boston Scientific EKOS Endovascular System, or EKOS, had lower rates of adverse events, including statistically significant lower rates of major bleeding, within seven days following their procedure compared to the Inari FlowTriever System. The REAL-PE study reviewed data from Truveta, a data and analytics company that provides EHR data from more than 30 U.S. health systems and 100M patients, including lab values, co-morbidities, images, demographics and clinical outcomes, as well information about the performance of specific medical devices. In the REAL-PE analysis, 2,259 patients who experienced PE and received interventional treatment with either the EKOS system or the FlowTriever system between 2009 and 2023 were identified, and safety events associated with both devices were compared. Major bleeding events in the REAL-PE study were based on definitions derived from established clinical criteria and guidelines, with statistically significant lower rates within seven days of the procedure consistently found in the cohort of patients treated with the EKOS system: A rate of 12.4% for patients treated with the EKOS system vs. 17.3% for those treated with the FlowTriever system, using the International Society on Thrombosis and Haemostasis, or ISTH, definition, and; a rate of 11.8% for patients treated with the EKOS system vs. 15.4% for those treated with the FlowTriever system, using the Bleeding Academic Research Consortium type 3b definition. Medical coding data in the analysis also demonstrated that intracerebral hemorrhage within seven days following the procedure occurred statistically significant less frequently among patients treated with the EKOS system. All other studied safety events also trended in favor of the EKOS system, including in-hospital mortality and all-cause 30-day readmission rates. Median lengths of hospital stay were comparable at 3.6 days for both groups. To date, the EKOS system has been used to treat more than 100,000 patients with PE globally, and the next-generation EKOS+ Endovascular System received FDA 510(k) clearance in 2022.