Endovascular Engineering (E2) has completed patient enrolment in the pivotal cohort of its ENGULF trial, involving the Hēlo pulmonary embolism (PE) thrombectomy system.
The investigational device exemption study was carried out at 19 interventional cardiology, radiology, and vascular surgery centres in the USA.
E2’s system features a patented dual-action mechanism that combines aspiration with clot disruption. It is designed to treat PE, a serious condition where blood clots in the lungs.
A recent press release made by the company describes that the Flow Mitigation Technology integrated into the system aids physicians in clot removal while reducing the loss of blood, a critical aspect of PE treatment.
The Hēlo PE thrombectomy system is still an investigational device.
ENGULF national principal investigator at Piedmont Atlanta Hospital in Atlanta, USA Andrew Klein said: “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.
“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.”
E2 noted that PE remains a leading cause of cardiovascular mortality and disability, with present treatments often requiring a balance between safety and effectiveness. The study aims to show that the system can address both concerns.
E2 chief executive officer Dan Rose said: “Our physician partners, patient volunteers, and the E2 team share the common purpose of improving the treatment of PE.
“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 USA.”
In February, the company secured an oversubscribed US$42m in a series B financing round to advance the development of its Hēlo system, targeting venous thromboembolism (VTE).
