The U.S. FDA cleared the Hēlo Thrombectomy System for lung clot removal, following positive results from the ENGULF trial. The suction-and-agitation platform was built by engineers and neurosurgeons at the University of Michigan and commercialized by startup Endovascular Engineering. For interventional teams, the clearance adds another minimally invasive option aimed at improving outcomes in patients with pulmonary embolism, where timely clot retrieval can be critical and evidence has historically centered on procedure safety and efficacy. The device’s core differentiator is its combined suction and agitation approach, intended to improve clot extraction mechanics in the pulmonary vasculature relative to purely suction-based concepts.