E2 (Endovascular Engineering, Inc.) Announces Completion of Enrollment in the ENGULF Pivotal Cohort for Treatment of Pulmonary Embolism

Pivotal trial evaluates safety and efficacy of the Hēlo™ PE Thrombectomy System for the removal of blood clots from the lungs

MENLO PARK, Calif., June 23, 2025 /PRNewswire/ -- E2 (Endovascular Engineering, Inc.), a medical device company advancing endovascular therapies, today announced the completion of patient enrollment in the pivotal cohort of its ENGULF Investigational Device Exemption (IDE) study. The trial evaluates the Hēlo™ PE 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 ENGULF trial represents an impressive journey of innovation during which E2 and investigators were able to introduce and evaluate several new technologies within the trial," said Dr. Andrew Klein, ENGULF National Principal Investigator at Piedmont Hospital in Atlanta. "It is an exciting and dynamic period of evolution in the use of mechanical thrombectomy to treat and manage our patients with this potentially fatal condition."

The ENGULF Study (NCT05597891) was conducted at 19 leading U.S. interventional cardiology, radiology and vascular surgery centers. 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 PE Thrombectomy System.

"The quick enrollment and collaborative spirit of the ENGULF investigators was remarkable and an indicator of the excitement around the opportunity to evaluate new technologies for PE like the Hēlo System," said Dr. Julie Bulman, Co-Principal Investigator from Beth Israel Deaconess Medical Center in Boston. "We look forward to reporting the outcomes of the trial later this year and adding to the important body of evidence for the treatment of Pulmonary Embolism."

The Hēlo PE Thrombectomy System represents a breakthrough in clot removal technology, featuring a patented dual-action mechanism that integrates powerful aspiration with advanced clot disruption. The Hēlo Thrombectomy System incorporates Flow Mitigation Technology™, enabling physicians to remove clot while minimizing blood loss—a critical factor in treating patients with PE.

"Our physician partners, patient volunteers, and the E2 team share the common purpose of improving the treatment of PE," said Dan Rose, CEO of E2. "We believe the Hēlo System offers distinct advantages over the current standard of care and now we are one very large step closer to making this life-saving technology available to patients across the U.S."

Pulmonary embolism is a major cause of cardiovascular death and disability. Current treatments often face trade-offs between effectiveness and safety. The ENGULF study aims to demonstrate that the Hēlo Thrombectomy System can address both.

E2 extends sincere thanks to its clinical partners, investigators, and strategic investors for their continued support. The company looks forward to sharing study outcomes and continuing its mission to redefine PE intervention.

About Endovascular Engineering, Inc.
Endovascular Engineering, Inc. ("E2"), is at the forefront of transforming venous thromboembolism (VTE) treatment. As a venture-backed medical technology innovator with multiple strategic investors, E2 is dedicated to developing and deploying groundbreaking solutions that advance the standard of care in clot removal. The company's technology platform represents the convergence of clinical insight and engineering excellence, aimed at addressing the complex challenges in VTE intervention.

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

For more information, please visit www.e2helo.com and follow us on LinkedIn @EndovascularEngineering.

Additional information about the trial (NCT05597891), including eligibility criteria and a list of clinical trial sites, can be found at https://clinicaltrials.gov/

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SOURCE Endovascular Engineering, Inc.