Endovascular Engineering (E2) has announced positive initial results from its ENGULF study, demonstrating successful outcomes among the first 15 patients evaluated in the trial using the Hēlo thrombectomy system for the treatment of acute sub-massive pulmonary embolism.
The ENGULF Study is a single-arm, multicentre, feasibility study evaluating the safety and performance of the Hēlo thrombectomy system, conducted under a US Food and Drug Administration (FDA) investigational device exemption (IDE).
An interim analysis of core lab adjudicated outcomes among the first 15 patients treated at seven sites demonstrated a significant reduction in right ventricular to left ventricular ratio (RV:LV), the FDA-recognised metric associated with increased morbidity and mortality. There were no major adverse events (MAE) reported for any of the patients through 30-day follow up.
The Hēlo Thrombectomy System is a next-generation technology that addresses clot removal in a single pass. Its dual-action technology simultaneously combines the power of aspiration with advanced mechanical clot disruption. The dual-action mechanism occurs within an atraumatic funnel tip, as the high-speed agitator actively engages and removes clot under controlled suction. Its low-profile design paired with this innovative approach facilitates the extraction of a wide range of clot morphology.
“The Hēlo Thrombectomy System has the potential to change how we perform thrombectomy by combining the power of aspiration with mechanical maceration to retrieve both fresh and organized thrombus,” said Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA). “The low-profile catheter along with the funnel tip allows for the ability to navigate both simple and complex anatomies without sacrificing lumen size. As the first next-generation thrombectomy system to receive this level of clinical evaluation, I look forward to completion of the clinical study and presentation of the results.”
“The device has thus far been very safe with no instances of pulmonary artery injury or cardiac injury noted,” said the national principal investigator, Jay Giri (Hospital of the University of Pennsylvania, Philadelphia, USA). “It has been easy to deliver in a single pass to the pulmonary arteries given its low profile and has the ability to remove clot in a differentiated way.”
“We are very pleased with the initial clinical experience observed during the ENGULF feasibility study and the tangible progress in our mission to provide a differentiated clinical solution to patients and physicians,” said Mike Rosenthal, CEO of E2. “The Hēlo Thrombectomy System is performing as expected in this clinical study. We look forward to additional enrolment in the ENGULF study and the continuation into the pivotal trial phase.”