E2 Receives Dual FDA Clearances for Thrombectomy System

Endovascular Engineering, Inc. (E2) announced it has received two 510(k) clearances from the U.S. Food and Drug Administration (FDA). The clearances are for the Hēlo® Thrombectomy System and the Hēlo® Return (Blood Return System), devices designed for the treatment of pulmonary embolism (PE).

Pulmonary embolism is a leading cause of cardiovascular death and disability, and there is a growing demand for mechanical solutions that can remove clots while reducing procedural complexity and strain on the heart. E2's Hēlo platform is designed to address these challenges, reportedly demonstrating efficient clot removal and low blood loss in the ENGULF IDE study.

The Hēlo Thrombectomy System is designed for navigation within pulmonary vasculature, utilizing a dual-action approach combining continuous aspiration and mechanical clot disruption. The Hēlo Return system, noted as the first blood return system cleared for use with continuous vacuum aspiration, is intended to minimize blood loss during the procedure.

The FDA clearances follow the review of clinical data from the ENGULF IDE study, which demonstrated the Hēlo Thrombectomy System's safety and efficacy. E2 stated that with these dual clearances, the company is accelerating plans to make the complete solution available to physicians and patients.