E2 wins FDA 510(k) clearance for Hēlo PE thrombectomy platform
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Menlo Park – October 12, 2026 -- Endovascular Engineering, Inc. (E2) has received U.S. FDA 510(k) clearance for both the Hēlo Thrombectomy System and Hēlo Return, a blood return system the company describes as the first cleared for use with continuous vacuum aspiration.
FDA clears two devices for pulmonary embolism treatment
The Hēlo platform is built for treating pulmonary embolism (PE). The FDA's decision followed its review of clinical data from the ENGULF IDE study, which demonstrated safety and efficacy of the Hēlo Thrombectomy System. E2 says it is now accelerating plans to bring the platform to a broad range of physicians and patients.