Endovascular Engineering’s Helo PE Thrombectomy System Evaluated in Pilot ENGULF Trial

November 3, 2024—Julie Bulman, MD, presented the results of the pilot ENGULF trial. The two-phase, prospective, single-arm study assessed the safety, feasibility, and efficacy of the Helo pulmonary embolism (PE) thrombectomy system (Endovascular Engineering). The Helo is a moderate-bore catheter with a flexible and expandable funnel and an internal agitator for the treatment of acute PE.

Dr. Bulman presented the findings in the late-breaking clinical trials session at The VEINS, the Venous Endovascular Interventional Strategies annual venous education symposium held by The VIVA Foundation on November 2-3 in Las Vegas, Nevada.

As summarized in the press release from The VEINS, the feasibility phase of ENGULF, which was composed of 25 patients, showed reductions in core lab-adjudicated right ventricular/left ventricular (RV/LV) ratio and modified Miller score (MMS), along with the primary safety endpoints.

In the ENGULF study, patients with intermediate-risk PE underwent a preprocedural and 48-hour postprocedural CT scan.

The primary efficacy outcome was the core lab–adjudicated difference in the pre- to postprocedural RV/LV ratio. Pre- and post-CTA scans were also reviewed for a reduction in MMS.

Primary and secondary safety outcomes were all-cause mortality, major life-threatening bleeding, device-related serious adverse events, pulmonary or cardiac injury, and clinical decompensation at 48 hours and 30 days postprocedure.

Of 25 patients from eight centers, baseline CT scans revealed a mean RV/LV ratio of 1.53 ± 0.27 and MMS of 15.68 ± 0.95. Embolectomy was successfully performed in all patients.

In the presentation at The VEINS, Dr. Bulman reported the following findings from ENGULF:

• Postprocedure mean RV/LV ratio was 1.15 ± 0.18, representing a 23.2% ± 12.81% reduction.
• Postprocedure MMS reduction was -2.6 ± 2.4, representing a 16.5% ± 15.3% reduction.
• The core lab-adjudicated measurement of clot burden showed a 83.8% ± 22.4% reduction in targeted vessels.
• There were no major adverse events at 48 hours and no deaths at 30 days.
• Anemia requiring transfusion but not meeting major bleeding criteria occurred in two patients postprocedure.

The ENGULF study concluded that the Helo PE thrombectomy system was safe and effective in treating acute PE and provides a notable reduction in core lab–adjudicated CTA thrombus burden, reported The VEINS press release.