Hēlo PE Thrombectomy System
Phase 3- Indications
- Pulmonary embolism, Venous thromboembolism
Company intelligence / Profile preview
Endovascular Engineering has completed a 25-patient feasibility phase of the ENGULF clinical trial for its Hēlo PE Thrombectomy System, demonstrating safety and feasibility in intermediate-risk pulmonary embolism patients. The pivotal phase is ongoing to support FDA 510(k) clearance. Early results show successful outcomes with the device for acute submassive PE; all pivotal trial patients are treated with an updated version of the system designed to optimize clot engagement and minimize blood loss.
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