Pivotal trial evaluated the safety and efficacy of the Hēlo™ Thrombectomy System for the removal of blood clots from the lungs
Dr. Andrew Klein, ENGULF National Co-Principal Investigator at Piedmont Hospital in Atlanta, today presented the positive results of the pivotal cohort of the ENGULF Investigational Device Exemption (IDE) study as a late-breaking clinical trial at the annual VIVA conference in Las Vegas. The data supports the technological advancements of the Hēlo™ Thrombectomy System, a novel technology designed for the treatment of pulmonary embolism (PE)—a life-threatening condition caused by blood clots in the lungs. The Hēlo Thrombectomy System represents a breakthrough in clot removal technology, featuring a unique combination of a 24F clot engagement zone and 15F heart crossing profile that integrates powerful aspiration with advanced clot remodeling.
“On behalf of the ENGULF Investigators, I am proud to share the positive results of the ENGULF study of the Hēlo Thrombectomy System,” said Dr. Andrew Klein. “E2 took a unique approach, by innovating the catheter and introducing new elements of the Hēlo system throughout the pivotal study – arriving at a complete platform for the treatment of PE.”
The ENGULF Study (NCT05597891) was conducted by 40 physician operators across interventional cardiology, interventional radiology, and vascular surgery specialties at 19 leading U.S. hospitals. A total of 105 patients were enrolled in the ITT population with a median of two cases per operator. The study met both its primary safety and efficacy endpoints by a wide margin, demonstrating a 0.95% major adverse event rate at 48 hours and 25.1% reduction in RV/LV ratio. Additionally, the study showed that the Hēlo system offers a single pass procedure and has workflow integrated blood return capabilities. It follows the successful feasibility cohort of the ENGULF IDE study that was published in JSCAI in May 2024. Both studies add to the body of clinical evidence highlighting the impact of the Hēlo Thrombectomy System.
“The results of the ENGULF pivotal cohort help highlight the marriage of purpose-driven technology development and clinical performance,” said Dr. Julie Bulman, Co-Principal Investigator from Beth Israel Deaconess Medical Center in Boston. “We want to thank all of our clinical research teams, supporting staff, and patient volunteers for doing their part to advance new innovation for treating pulmonary embolism with mechanical thrombectomy.”
Pulmonary embolism is a major cause of cardiovascular death and disability.1 The ENGULF study demonstrated that the Hēlo Thrombectomy System is safe and effective in treating these patients.
E2 extends sincere thanks to its clinical partners, investigators, and patient volunteers. The company looks forward to sharing additional study outcomes and continuing its mission to redefine PE intervention.
