Endovascular Engineering Secures FDA Clearance for Hēlo PE Platform

The Hēlo platform addresses a critical gap in cardiovascular care by combining a low-profile 15F catheter with a 24F ingestion funnel. This design allows physicians to navigate narrow pulmonary vasculature while maintaining the capacity for aggressive, single-pass clot removal. By integrating continuous vacuum aspiration with mechanical disruption, the system aims to reduce right heart strain and procedural duration.

Central to the system’s clinical value is the Hēlo Return component, the first blood-return technology cleared for continuous vacuum aspiration. During the ENGULF trial, this integration resulted in near-zero blood loss, a significant improvement over traditional thrombectomy methods that often require massive fluid replacement. Data presented at the Society of Interventional Radiology meeting earlier this year validated the device's ability to maintain blood quality under these conditions.

According to Dr. Eric Secemsky of Beth Israel Deaconess Medical Center, the technology directly targets the practical hurdles clinicians encounter during high-stakes pulmonary embolism interventions. With the regulatory green light, E2 CEO Dan Rose confirmed the company is now moving to scale production and distribution to hospitals, aiming to establish the Hēlo platform as a standard for venous thromboembolism care.