What's Happening?
Endovascular Engineering, Inc. (E2) presented the results of the ENGULF pivotal study at the VIVA conference, showcasing the efficacy of the Hēlo Thrombectomy System for treating pulmonary embolism (PE).
The study, involving 105 patients across 19 U.S. hospitals, demonstrated a 0.95% major adverse event rate and a 25.1% reduction in RV/LV ratio. The Hēlo system, designed for single-pass procedures, integrates powerful aspiration with advanced clot remodeling, marking a significant advancement in PE treatment.
Why It's Important?
Pulmonary embolism is a leading cause of cardiovascular death and disability. The positive results from the ENGULF study highlight the potential of the Hēlo Thrombectomy System to improve patient outcomes and set new standards in PE treatment. This innovation could lead to more effective and safer interventions, reducing the burden of PE on healthcare systems and improving quality of life for patients.
What's Next?
E2 plans to continue sharing study outcomes and advancing its mission to redefine PE intervention. The company is focused on further developing its technology platform and expanding its clinical partnerships. The Hēlo Thrombectomy System remains an investigational device, and E2 will likely pursue further regulatory approvals and clinical trials to bring this technology to market.
