Endovascular Engineering Announces First Patient Enrolled in ENGULF Pivotal Trial with its Hēlo™ PE Thrombectomy System for the Treatment of Pulmonary Embolism

USA - English

• USA - English

MENLO PARK, Calif., Feb. 20, 2024 /PRNewswire/ -- Endovascular Engineering, Inc. ("E2"), a pioneering medical device company at the forefront of advancing clot removal technologies for venous thromboembolism (VTE), proudly announces the enrollment and treatment of the first patient in the pivotal phase of its ENGULF US clinical trial. This IDE trial will further evaluate the safety and efficacy of the Hēlo PE Thrombectomy System, a first of its kind technology, for the treatment of pulmonary embolism (PE). This initial treatment, led by Malcolm Foster, MD, Director of the Cardiac Catheterization Lab at Tennova Turkey Creek Medical Center, located in Farragut, TN, represents a significant step forward on the path to introducing the novel Hēlo PE Thrombectomy System to the US market for the management of pulmonary embolism.

Enrollment of the first patient in the ENGULF pivotal cohort follows the completion of the 25-patient feasibility phase of the study.  All patients in the pivotal trial will be treated with the latest version of the Hēlo PE Thrombectomy System, equipped with a new accessory device designed to optimize clot engagement and blood loss management. "The integration of this new feature into the Hēlo System marks an impressive advancement, providing invaluable feedback that supports safe navigation for engaging target clot and helps to minimize blood loss throughout thrombectomy procedures," noted Dr. Foster.

Pulmonary embolism is a serious and potentially life-threatening condition that is most often caused by a blood clot originating in the legs, known as deep vein thrombosis. PE affects an estimated 900,000 people in the United States each year, leading to approximately 60,000 to 100,000 deaths annually¹. The mortality rate associated with pulmonary embolism remains high and unchanged in recent years, according to a Michigan Medicine Study, underscoring the persistent challenge posed by PE and the urgent need for advanced treatment options.

Mike Rosenthal, CEO of E2, emphasized the importance of initiating the ENGULF pivotal IDE trial stating, "This first procedure represents a critical milestone for our company as the ENGULF trial is a reflection of our commitment to advancing the field of thrombectomy and has been initiated ahead of schedule." Through clinical collaborations with leading medical institutions and clinicians like Dr. Malcolm Foster, E2 remains committed to improving patient outcomes and revolutionizing thrombectomy treatment.

¹Pulmonary embolism deaths, disparities high despite advancements in care (2023). Institute for Healthcare Policy & Innovation, University of Michigan, https://ihpi.umich.edu/news/pulmonary-embolism-deaths-disparities-high-despite-advancements-care

About Hēlo Thrombectomy System

The Hēlo PE Thrombectomy System is a first of its kind technology that removes clot with its patented dual-action approach that simultaneously combines the power of aspiration with advanced mechanical clot disruption. The dual-action mechanism occurs within a self-expanding funnel, as the high-speed agitator actively engages and removes clot under physician-controlled suction. This innovative approach efficiently and effectively extracts clot of mixed morphology. Hēlo operates with the agility of a small profile catheter yet boasts the capabilities of a large bore device in a single-pass operation, redefining thrombectomy.

About Endovascular Engineering, Inc.

Endovascular Engineering, Inc. ("E2"), is a mission-driven, venture-backed company focusing on the development and deployment of groundbreaking clot removal technologies that target venous thromboembolism (VTE).

The Hēlo PE Thrombectomy System for pulmonary embolism is for Investigational Use only and is not approved for commercial use. Hēlo Thrombectomy System is not available for sale.

For more information, please visit www.endovascularengineering.com or contact [email protected].

SOURCE Endovascular Engineering, Inc.