Results from the pivotal cohort of the ENGULF Investigational Device Exemption (IDE) study evaluating Endovascular Engineering’s (E2) Hēlo™ Thrombectomy System were presented as a late-breaking clinical trial at the annual VIVA conference. The data showed that the system achieved both its primary safety and efficacy endpoints, underscoring its potential as a next-generation technology for pulmonary embolism (PE) treatment.
Study Overview
The ENGULF Study (NCT05597891) included 105 patients across 19 U.S. hospitals, with 40 physician operators from interventional cardiology, interventional radiology, and vascular surgery specialties. The study met its primary endpoints, demonstrating a 0.95% major adverse event rate at 48 hours and a 25.1% reduction in right ventricle/left ventricle (RV/LV) ratio, a key marker of heart strain in PE patients.
The Hēlo system also enabled single-pass clot removal and integrated workflow blood return capabilities, indicating potential procedural efficiency benefits.
Technology Innovation
The Hēlo Thrombectomy System features a 24F clot engagement zone with a 15F heart-crossing profile, combining high-power aspiration with advanced clot remodeling for targeted, large-vessel clot removal.
“E2 took a unique approach by evolving the catheter design throughout the pivotal study—arriving at a complete platform for PE treatment,” said Dr. Andrew Klein, National Co-Principal Investigator and interventional cardiologist at Piedmont Hospital, Atlanta.
“The results highlight the union of purpose-driven technology and clinical performance,” added Dr. Julie Bulman, Co-Principal Investigator from Beth Israel Deaconess Medical Center, Boston.
Clinical Context
Pulmonary embolism is a leading cause of cardiovascular mortality worldwide. The ENGULF pivotal results build upon findings from the earlier feasibility cohort, published in JSCAI (May 2024), and contribute to growing evidence supporting mechanical thrombectomy as a frontline intervention for high-risk PE.
E2 stated it will continue to collaborate with investigators and share additional data as part of its ongoing commitment to advancing venous thromboembolism (VTE) treatment.
About Endovascular Engineering (E2)
Endovascular Engineering, Inc. (E2) is a medtech innovator developing novel solutions for venous thromboembolism intervention. The company’s Hēlo™ platform integrates clinical insight with advanced engineering to improve outcomes in clot removal. The Hēlo Thrombectomy System is currently an investigational device and not yet FDA approved.
