FDA Clears E2 Hēlo Thrombectomy System and Integrated Blood Return System

October 13, 2026—Endovascular Engineering, Inc. (E2), a developer of technology for venous thromboembolism, announced FDA 510(k) clearance for both the Hēlo thrombectomy system and Hēlo Return, a blood return system. The platform is compatible with continuous vacuum aspiration, advised the company.

According to E2, the Hēlo thrombectomy system is indicated for the nonsurgical removal of emboli and thrombi from pulmonary arteries and venous vasculature. The system allows for injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels. It is intended for use in the peripheral veins and for the treatment of pulmonary embolism.

The company further advised that Hēlo Return is indicated for use with the Hēlo thrombectomy system to collect and filter the aspirated whole blood from the thrombectomy procedure, before returning blood back to the patient.

The company stated that the FDA’s decision to grant 510(k) clearance comes after the agency’s review of clinical data from the ENGULF investigational device exemption (IDE) study, which demonstrated safety and efficacy of the Hēlo thrombectomy system.

The company announced that data from the study were presented at the Society of Interventional Radiology annual scientific meeting in April 2026.

According to the company, the ENGULF IDE study showed that the Hēlo thrombectomy platform consistently allowed for efficient single-pass procedures for treating PE. Additionally, the platform demonstrated high clot reduction and low estimated blood loss.

“The treatment of PE with mechanical thrombectomy is rapidly evolving as emerging data and new technologies continue to shape the field,” commented Eric Secemsky, MD, in E2’s press release. Dr. Secemsky, Director of Vascular Intervention at Beth Israel Deaconess Medical Center in Boston, Massachusetts, continued, “These clearances mark an important milestone in that evolution. The platform addresses real practical challenges we face in these procedures, and I believe it has the potential to meaningfully expand access to mechanical thrombectomy for a broad range of patients.”