Endovascular Engineering Helo Thrombectomy System for Acute PE Evaluated in ENGULF Trial

May 3, 2024—Late-breaking data from the ENGULF trial showed that the dual-action Helo pulmonary embolism (PE) thrombectomy system (Endovascular Engineering [E2]) was effective and safe in treating acute PE. The device features a steerable and expandable funnel and an internal agitator. ENGULF is a prospective, single-arm, first-in-human, safety and feasibility study.

The safety and effectiveness results were presented as late-breaking science at SCAI 2024, the Society for Cardiovascular Angiography & Interventions scientific sessions held May 2-4 in Long Beach, California. The study was simultaneously published by Tai Kobayashi MD, et al in JSCAI.

As summarized in the SCAI press release, patients in the ENGULF study underwent pre- and 48-hour postprocedural CT scans. The primary efficacy outcome was the percent difference in the pre-to-postprocedural right ventricle to left ventricle (RV/LV) ratios. The 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.

All 25 patients from eight centers underwent successful embolectomy. The mean RV/LV ratio was 1.53 ± 0.27 at baseline and 1.15 ± 0.18 at 48 hours postprocedure (23.2% ± 12.81% change). Of note, there were no major adverse events at 48 hours and no deaths at 30 days, stated the SCAI press release.

“Although more rigorous studies are needed, RV/LV ratio is the most important predictor of dysfunction and adverse outcomes in acute PE, and it is exciting to see that the RV/LV ratio reduction was just as much as other FDA-approved devices on the market without any large safety concerns in a new first-in-human device,” commented Dr. Kobayashi in the society’s press release.

He continued, “This technology represents the marriage between large- and small-bore embolectomy, which allows for operators to travel through the heart with a smaller catheter but expand a larger funnel that matches the size of the large-bore catheters, leaving a smaller footprint and lowering the risk of hemodynamic impact for the patient.”

Jay Giri, MD, National Principal Investigator of the study, added, “For the field of interventional PE therapies to fully reach its promise, continued innovation is needed to optimize our procedural workflows across the wide array of patients affected by this disease. The ENGULF trial is an important step in this process, demonstrating that a novel, purpose-built PE thrombectomy catheter can achieve excellent results even among its earliest users.”

Dr. Kobayashi is Assistant Professor of Clinical Medicine at Penn Medicine, and Dr. Giri is Director of the Cardiovascular Catheterization Laboratories at the Hospital of the University of Pennsylvania in Philadelphia, Pennsylvania.