E2 Secures Dual FDA Clearances for the Hēlo® Platform, Introducing a PE Thrombectomy System with Integrated Blood Return

Combination of Hēlo Thrombectomy System and Hēlo Return establish the first 510(k)-cleared platform compatible with continuous vacuum aspiration

MENLO PARK, Calif., Oct. 12, 2026 /PRNewswire/ -- Endovascular Engineering, Inc. (E2), a commercial-stage medical technology company focused on advancing the treatment of venous thromboembolism (VTE), today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for both the Hēlo® Thrombectomy System and Hēlo® Return (Blood Return System).  

Hēlo, which is a physician-inspired, purpose-built thrombectomy platform for treating pulmonary embolism, leverages a unique design that consistently led to efficient single-pass procedures in the ENGULF IDE study. The platform showcased the highest reported clot reduction and the lowest estimated blood loss across all PE Thrombectomy IDE studies.¹ While ENGULF provided important clinical validation of the platform's capabilities, the FDA clearances represent a significant step forward as E2 brings its innovative platform to a broad range of physicians and patients. PE remains a leading cause of cardiovascular death and disability, and there is growing demand for mechanical solutions that support clot removal while reducing procedural complexity and right heart strain.

"The treatment of PE with mechanical thrombectomy is rapidly evolving as emerging data and new technologies continue to shape the field. These clearances mark an important milestone in that evolution," said Eric Secemsky, MD, Director of Vascular Intervention, Beth Israel Deaconess Medical Center in Boston. "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."

The Hēlo Thrombectomy System is a lower profile platform designed to navigate small and act big. Its 15F crossing profile and steerable navigation enables physician-controlled movement within the pulmonary vasculature. A 24F clot ingestion funnel on the distal end of the catheter helps pull in clots that are then remodeled through a dual-action approach combining continuous aspiration and mechanical clot disruption.

Hēlo Return completes the platform by providing workflow-integrated blood return when used with the Hēlo Thrombectomy System, leading to near-zero blood loss as observed during the ENGULF trial. Supported by testing conducted in accordance with FDA guidance to evaluate blood quality under continuous vacuum conditions, Hēlo Return is the first blood‑return system cleared for use with continuous vacuum aspiration. Data from the testing was presented at the Society of Interventional Radiology (SIR) Annual Scientific Meeting in April 2026.

"This milestone is the culmination of years of focused innovation to create a unique and complete platform that addresses the procedural limitations physicians currently experience when treating PE," said Dan Rose, CEO of E2. "Physicians have communicated their needs clearly: large-bore clot removal performance in a low-profile catheter, with a single pass procedure and integrated blood return capability. The Hēlo System offers all these features and more. With dual FDA clearances in hand, we are accelerating our plans to deliver this complete solution to a broad range of physicians and patients."

The FDA's decision to grant 510(k) clearance follows its review of clinical data from the ENGULF IDE study, which demonstrated safety and efficacy of the Helo Thrombectomy System.

¹ Reported across all published pulmonary embolism pivotal studies. ENGULF results shown for patients treated with blood return (N=40). Cross-study comparisons are descriptive only and limited by differences in study design, patient populations, and endpoints. Not derived from head-to-head trials. ENGULF data on file.

About Endovascular Engineering, Inc.
Endovascular Engineering, Inc. (E2) is a commercial-stage medical technology company focused on advancing the treatment of venous thromboembolism (VTE). The company develops and commercializes solutions designed to improve clinical outcomes and procedural efficiency in clot removal, aimed at addressing the complex challenges in VTE intervention. E2 is backed by leading investors including Norwest, Gilde Healthcare, Santé Ventures, 415 Capital, S3 Ventures, Panakès Partners and M&L Healthcare Investments.

Hēlo Thrombectomy System – Indications for Use

The Hēlo Thrombectomy System is indicated for the non-surgical 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. The Hēlo Thrombectomy System is intended for use in the peripheral veins and for the treatment of pulmonary embolism. 

The Hēlo Blood Return System (Hēlo Return) is indicated for use with the Hēlo Thrombectomy System to collect and filter the aspirated whole blood from the thrombectomy procedure, prior to returning blood back to the patient.

Caution: Federal (U.S.) law restricts these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use.

For more information, please visit www.e2helo.com and follow us on LinkedIn @E2-EndovascularEngineering.

SOURCE Endovascular Engineering, Inc.