#USA #Menlo Park #Endovascular Engineering #Hēlo Thrombectomy #Pulmonary Embolism

E2 Completes Enrollment for Innovative Pulmonary Embolism Treatment

E2 (Endovascular Engineering, Inc.), a key player in the medical device industry focusing on endovascular therapies, has announced a significant milestone: the completion of patient enrollment for the ENGULF pivotal cohort study. This groundbreaking trial centers around the Hēlo™ PE Thrombectomy System, a vital new technology designed specifically for tackling pulmonary embolism (PE), a condition that can be life-threatening because of blood clots obstructing lung arteries.

Dr. Andrew Klein, serving as the National Principal Investigator for the ENGULF trial, emphasized the remarkable journey of innovation that the study represents. Conducted across 19 prestigious interventional cardiology, radiology, and vascular surgery centers throughout the United States, the trial showcases both the collaborative spirit of leading healthcare professionals and the potential for introducing new technologies to manage this critical condition more effectively.

The ENGULF Study, registered as NCT05597891, follows the earlier successful feasibility phase published in the Journal of the Society for Cardiovascular Angiography and Interventions (JSCAI) in May 2024. Both studies provide a compelling array of clinical evidence underscoring the efficacy of the Hēlo PE Thrombectomy System.

Dr. Julie Bulman, Co-Principal Investigator from Beth Israel Deaconess Medical Center in Boston, praised the swift enrollment process, which reflects the excitement surrounding the exploration of new technologies for pulmonary embolism treatment. As the study progresses, Dr. Bulman and her colleagues eagerly anticipate reporting on the trial's outcomes later this year, further enriching the treasure trove of data available for clinicians dealing with pulmonary embolism.

The Hēlo PE Thrombectomy System stands out due to its pioneering dual-action mechanism. This system features an advanced approach that combines high-powered aspiration with effective clot disruption techniques. It employs what is termed Flow Mitigation Technology™, allowing physicians to efficiently remove clots while minimizing blood loss, which is a critical factor in treating patients suffering from pulmonary embolism.

Dan Rose, CEO of E2, conveyed his gratitude to the involved physician partners, patient volunteers, and the team at E2, all united in a shared mission to enhance pulmonary embolism treatments. He firmly believes that the Hēlo System offers unique advantages compared to currently available treatment options and expresses excitement at bringing this life-saving technology to patients across the United States.

Pulmonary embolism is a significant contributor to cardiovascular morbidity and mortality. Among existing treatment options, physicians often encounter a dilemma, having to balance effectiveness with safety. The ENGULF study aims to illustrate that the Hēlo Thrombectomy System can navigate these challenges effectively.

E2 expresses its sincere gratitude to its clinical partners, investigators, and strategic investors for their unwavering support throughout this endeavor. The company is enthusiastic about sharing the results of this vital study and is committed to its goal of redefining interventions for pulmonary embolism.

About Endovascular Engineering, Inc.
Endovascular Engineering, Inc. (E2) is on the cutting edge of transforming treatment approaches for venous thromboembolism (VTE). As a venture-backed innovator in the medical technology space, E2 is devoted to developing and launching pioneering solutions aimed at enhancing the standard of care in clot removal. The organization thrives on combining clinical insight with engineering excellence to tackle the complex challenges of VTE intervention.

Caution: The Hēlo PE Thrombectomy System is currently an investigational device, limited by federal law to investigational use.

For more information, visit E2 Hēlo and follow E2 on LinkedIn for the latest updates on their groundbreaking work.