Two FDA 510(k) clearances have been granted to Endovascular Engineering, the company known as E2, covering its Helo thrombectomy system along with Helo Return, a companion device that returns blood to the patient. Venous thromboembolism is the clinical focus of the developer.
Nonsurgical removal of emboli and thrombi from the pulmonary arteries and venous vasculature is what the Helo system is indicated for, and it also supports injection, infusion or aspiration of contrast media and other fluids. Uses for the device include the peripheral veins, where it also serves in treating pulmonary embolism. Continuous vacuum aspiration is compatible with the platform.
## Why the blood return piece matters
A practical objection to aspiration-based thrombectomy is addressed by pairing a clot-removal device with a dedicated blood-return system: along with the clot, the procedure can draw off a substantial volume of the patient’s own blood, which matters most in patients who are already unstable.
Competing on returning that blood is something device makers have done, and marketing a complete circuit rather than a lone catheter is possible for E2 because both components were cleared together.
An $80M Series C was raised previously by E2 to advance its next-generation thrombectomy platform as pulmonary embolism treatment has shifted toward interventional approaches. Commercial launch timing has not been announced by the company.
