Endovascular Engineering, which goes by E2, said on October 12 that it holds two FDA 510(k) clearances, one for the Helo Thrombectomy System and one for Helo Return. The thrombectomy indication covers non surgical removal of emboli and thrombi from the pulmonary arteries and the venous vasculature, plus injection, infusion and aspiration of contrast media and other fluids. Helo Return collects aspirated whole blood, filters it and sends it back to the patient.
The catheter crosses at 15F and opens to a 24F clot ingestion funnel. E2 says the pair is the first cleared platform compatible with continuous vacuum aspiration, and that Helo Return is the first blood return system cleared to work with it. Both clearances rested on data from the ENGULF IDE study, with blood return results in 40 patients and blood quality testing presented at the SIR annual scientific meeting in April.
E2 is backed by Norwest, Gilde Healthcare, Sante Ventures, 415 Capital, S3 Ventures, Panakes Partners and M&L Healthcare Investments. Clearing the return path alongside the aspiration catheter answers the blood loss objection that has followed large bore aspiration in pulmonary embolism, and it answers it without a second vendor's device in the room.