Endovascular Engineering (E2) has announced US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for its ENGULF US pivotal trial.
The study will evaluate the safety and effectiveness of the Hēlo thrombectomy system in treating pulmonary embolism (PE). The approval of the IDE follows the successful completion of the company’s 25-patient feasibility study.
“We are excited to be at the forefront of this innovative procedure with the completion of the ENGULF feasibility study. This significant achievement sets the stage for definitive results in the ENGULF pivotal trial. The Hēlo thrombectomy system represents a significant leap forward in pulmonary embolism treatment, and I am enthusiastic about investigating its full potential in the upcoming phase of the study,” said Jay Giri (University of Pennsylvania, Philadelphia, USA) the national principal investigator (PI) for the ENGULF feasibility study.
“We intend to build upon the robust foundation of clinical success we’ve seen thus far, solidifying the Hēlo thrombectomy system’s role as a transformative force in the treatment of pulmonary embolism,” said Andrew Klein (Piedmont Heart Institute, Atlanta, USA), the national PI for the ENGULF pivotal study.
Mike Rosenthal, CEO of E2, commented: “The positive results from our feasibility study give us confidence as we enter the pivotal phase. The Hēlo system introduces a differentiated technology with the potential to advance PE treatment options. Embarking on our ENGULF pivotal trial is a significant step, further validating the system’s safety and efficacy. It advances our efforts toward introducing this innovative technology to the market, ultimately helping patients with PE.”