#USA #Las Vegas #e2 #ENGULF Study #Hēlo System

E2's Groundbreaking Announcement at VIVA Conference

In an exciting development for medical technology, E2 (Endovascular Engineering, Inc) recently showcased the results of their ENGULF pivotal study at the VIVA Conference held in Las Vegas. Dr. Andrew Klein, the National Co-Principal Investigator from Piedmont Hospital in Atlanta, presented compelling data regarding the Hēlo™ Thrombectomy System, a device aimed at addressing the urgent need for effective treatment options for pulmonary embolism (PE).

The Significance of the Hēlo System

The Hēlo™ Thrombectomy System stands out in the realm of medical devices, designed specifically for the removal of blood clots from the lungs—a condition that poses serious risks to cardiovascular health. With a unique combination of features, including a 24F clot engagement zone and a 15F heart crossing profile, the system integrates powerful aspiration capabilities with advanced clot remodeling techniques. This innovation brings a much-needed enhancement to the methods employed in PE treatment.

“On behalf of the ENGULF Investigators, I am proud to share the positive results of the ENGULF study of the Hēlo Thrombectomy System,” expressed Dr. Klein. He emphasized that E2's approach was distinct and innovative—not merely providing a catheter, but rather enhancing the entire treatment platform for PE.

The ENGULF Study Findings

The pivotal ENGULF study, registered under the identifier NCT05597891, involved 105 patients across 19 prominent hospitals in the United States, showcasing a collaboration between 40 physician operators specializing in interventional cardiology, radiology, and vascular surgery. The results exceeded expectations, achieving both primary safety and efficacy endpoints substantially.

The major adverse event rate within 48 hours was an impressive 0.95%, coupled with a 25.1% reduction in the RV/LV ratio—a critical measurement in assessing cardiovascular performance. Additionally, the Hēlo system's capability for a single-pass procedure while integrating blood return workflow highlighted its efficiency and ease of use for clinicians.

This study followed a successful feasibility cohort published earlier in May 2024. Together, these studies deepen the clinical evidence illustrating the transformative potential of the Hēlo Thrombectomy System in treating pulmonary embolism.

Expert Insights

Dr. Julie Bulman, Co-Principal Investigator from Beth Israel Deaconess Medical Center in Boston, reflected on the importance of the results. “The findings of the ENGULF pivotal cohort underscore the effective synergy between purposeful technology development and clinical performance,” she stated. Profound acknowledgments were given to the clinical research teams, supporting staff, and patient volunteers who played vital roles in advancing innovative treatment methods for pulmonary embolism through mechanical thrombectomy.

The Challenge of Pulmonary Embolism

Pulmonary embolism, associated with high mortality and disability rates, represents a major challenge within cardiovascular medicine. The emergence of the Hēlo Thrombectomy System shows promise in effectively addressing this pressing health concern, making significant strides toward better patient outcomes.

As E2 expresses its gratitude toward its countless clinical partners, investigators, and patient volunteers, the company is eager to disseminate further study outcomes. Their commitment to rethinking interventions aimed at treating pulmonary embolism remains steadfast.

About Endovascular Engineering, Inc

E2 stands as a transformative force in the realm of venous thromboembolism (VTE) treatment, driven by a robust backing from strategic investors. The company is committed to developing and deploying innovative solutions that aim to advance the standard of care in clot removal. E2’s technology platform exemplifies the intersection of clinical insight and engineering excellence, crafted to tackle the complex challenges of VTE intervention.

As an investigational device, the Hēlo Thrombectomy System is currently limited by federal law to investigational use—a factor underscoring the ongoing nature of research in this field. For more detailed information and updates, visit E2's official website and follow them on LinkedIn: @E2-EndovascularEngineering.