Hēlo, which is a physician-inspired, purpose-built thrombectomy platform for treating pulmonary embolism, leverages a unique design that consistently led to efficient single-pass procedures in the ENGULF IDE study. The platform showcased the highest reported clot reduction and the lowest estimated blood loss across all PE Thrombectomy IDE studies.1 While ENGULF provided important clinical validation of the platform’s capabilities, the FDA clearances represent a significant step forward as E2 brings its innovative platform to a broad range of physicians and patients. PE remains a leading cause of cardiovascular death and disability, and there is growing demand for mechanical solutions that support clot removal while reducing procedural complexity and right heart strain.
“The treatment of PE with mechanical thrombectomy is rapidly evolving as emerging data and new technologies continue to shape the field. These clearances mark an important milestone in that evolution,” said Eric Secemsky, MD, Director of Vascular Intervention, Beth Israel Deaconess Medical Center in Boston. “The platform addresses real practical challenges we face in these procedures, and I believe it has the potential to meaningfully expand access to mechanical thrombectomy for a broad range of patients.”