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Boston Scientific has declared that findings from the REAL-PE study indicate that patients who received treatment for pulmonary embolism (PE) using the EKOS Endovascular System experienced lower rates of major bleeding in comparison to those treated with the Inari FlowTriever system.

The system demonstrated a decreased occurrence of adverse events, notably a notable reduction in bleeding within the first seven days post-procedure, when compared to the Inari system.

The study evaluated data sourced from Truveta, a data and analytics company with access to electronic health records (EHR) from over 30 US healthcare systems and a database encompassing 100 million patients. This dataset includes demographic information, clinical outcomes, co-morbidities, medical images, laboratory values, and details related to the performance of specific medical devices.

In the REAL-PE analysis, a total of 2,259 patients who underwent interventional treatment using either the EKOS system or the FlowTriever system for PE between 2009 and 2023 were identified. The primary focus was to compare safety events associated with both devices.

The analysis of medical coding data also revealed a statistically significant reduction in the incidence of intracerebral hemorrhage within seven days following the procedure in patients treated with the EKOS system.

Boston Scientific clinical affairs, technology and innovation, peripheral interventions vice-president and chief medical officer Michael Jaff said: “EHR data of this scale provides in-depth information about larger, more diverse patient populations while also accounting for multiple variables, including complex medical histories or co-morbidities that often exclude patients from clinical trials.”

To date, the EKOS system has been employed in the care of more than 100,000 patients suffering from PE on a global scale.

Last year, the advanced EKOS+ endovascular system received 510(k) clearance from the US Food and Drug Administration.

© Boston Scientific