FDA clears Endovascular Engineering Hēlo thrombectomy and blood-return systems for pulmonary embolism treatment

The FDA has granted 510(k) clearances for Endovascular Engineering's Hēlo thrombectomy and blood-return systems, advancing an integrated approach to pulmonary embolism treatment.

The Hēlo Thrombectomy System uses continuous vacuum aspiration to remove thrombotic material, while the Hēlo Return system is designed to support blood recovery during interventional procedures.

The clearances establish an important regulatory milestone for the combined platform, which aims to support effective clot removal while limiting procedural blood loss in pulmonary embolism interventions.

Field	Content
Article Type	Approvals
Device Names	Hēlo Thrombectomy System; Hēlo Return
Company	Endovascular Engineering
Regulatory Authority	U.S. Food and Drug Administration
Regulatory Decision	510(k) clearances
Approval Type	Medical device clearance
Clinical Application	Pulmonary embolism thrombectomy
Therapy Area	Interventional cardiovascular medicine; pulmonary embolism
Technology/Modality	Mechanical thrombectomy using continuous vacuum aspiration with an integrated blood-return system
Thrombectomy Component	Hēlo Thrombectomy System
Blood Management Component	Hēlo Return
System Function	Aspiration-based thrombus removal with blood recovery capabilities
Intended Clinical Benefit	Support clot removal while limiting procedural blood loss
Geography	United States
What Happened	The FDA granted 510(k) clearances for Endovascular Engineering's Hēlo Thrombectomy System and Hēlo Return blood-return system.
Why It Matters	The clearances advance an integrated thrombectomy platform designed to address both clot removal and blood management during pulmonary embolism procedures.
Supporting Context	Continuous vacuum aspiration can facilitate mechanical clot extraction, while the blood-return component is intended to reduce procedural blood loss.
Potential Impact	The platform could expand device options for clinicians performing catheter-based pulmonary embolism interventions.
Key Takeaway	Endovascular Engineering has received FDA 510(k) clearances for its Hēlo thrombectomy and blood-return systems.
What to Watch	US commercial availability, hospital adoption, clinical performance data, procedural outcomes and integration into pulmonary embolism treatment pathways.
Primary Source	Diagnostic and Interventional Cardiology
Relevant Date	12 October 2026

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