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  • Endovascular Engineering's Hēlo™ Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism

    MENLO PARK, Calif., Jan. 11, 2024 /PRNewswire/ -- Endovascular Engineering ("E2"), a medical device company focused on the development and deployment of groundbreaking clot removal technologies that target venous thromboembolism (VTE), announced today FDA Investigational Device Exemption (IDE) approval for its ENGULF US pivotal trial. This study will evaluate the safety and effectiveness of the Hēlo Thrombectomy System in treating pulmonary embolism (PE), marking a significant step forward in the development of innovative clot removal technologies for VTE. The approval of the IDE follows the successful completion of the company's 25-patient feasibility study.

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