Boston Scientific has announced that the REAL-PE study revealed patients treated with its EKOS Endovascular System for pulmonary embolism (PE) experienced reduced rates of major bleeding compared to those treated with the Inari FlowTriever system.
The system showed a lower incidence of adverse events, including a statistically significant reduction in bleeding within seven days post-procedure, when compared to the Inari system.
The study assessed information sourced from Truveta, a data and analytics company with access to electronic health records (EHR) from more than 30 US healthcare systems and a database covering 100 million patients.
This data consists of demographics and clinical outcomes, co-morbidities, images, lab values and information regarding the performance of particular 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, with a focus on comparing safety events associated with both devices.
The analysis of medical coding data also showed a statistically significant reduction in the occurrence of intracerebral haemorrhage within seven days after the procedure in patients treated with the EKOS system.
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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.”
So far, the EKOS system has been used to treat over 100,000 patients with PE worldwide.
The next-generation EKOS+ endovascular system obtained 510(k) clearance from the US Food and Drug Administration last year.