What's Happening?
Endovascular Engineering, Inc. (E2) has presented the results of the ENGULF pivotal study at the VIVA conference, showcasing the safety and efficacy of the Hēlo Thrombectomy System for treating pulmonary embolism (PE). The study, conducted across 19 U.S.
hospitals, involved 105 patients and demonstrated a 0.95% major adverse event rate and a 25.1% reduction in RV/LV ratio. The Hēlo system, designed for single-pass clot removal, integrates powerful aspiration with advanced clot remodeling, offering a novel approach to PE treatment.
Why It's Important?
The ENGULF study's findings are significant as they highlight the potential of the Hēlo Thrombectomy System to improve treatment outcomes for patients with pulmonary embolism, a major cause of cardiovascular death. The system's innovative design and positive safety profile could lead to its adoption as a standard treatment option, potentially reducing mortality and improving quality of life for PE patients. The study also underscores the importance of technological advancements in medical devices, which can enhance treatment efficacy and patient outcomes.
What's Next?
Following the positive results of the ENGULF study, E2 may seek regulatory approval for the Hēlo Thrombectomy System, aiming to bring this innovative treatment to market. The company may also conduct further studies to explore the system's long-term benefits and potential applications in other thromboembolic conditions. As the medical community evaluates these findings, the Hēlo system could become a key tool in the management of pulmonary embolism.
