ENGULF Pivotal Trial Completes Enrollment

June 23, 2025—Endovascular Engineering, Inc. (E2) announced the completion of patient enrollment in the pivotal cohort of the ENGULF investigational device exemption (IDE) study of its Helo thrombectomy system for the treatment of pulmonary embolism (PE). According to the company, the ENGULF study was conducted at 19 interventional cardiology, radiology, and vascular surgery centers in the United States.

In May 2024, the company announced findings from the feasibility cohort of the ENGULF IDE study at SCAI 2024, which were simultaneously published by Tai Kobayashi, MD, et al in JSCAI.

ENGULF Coprincipal Investigators Andrew Klein, MD, and Julie Bulman, MD, discussed the trial in the company’s press release.

“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,” commented Dr. Klein. “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.”

Dr. Bulman added, “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 Helo system. 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 PE.”

The Helo PE thrombectomy system is an investigational device, limited by federal law to investigational use, advised E2.