Endovascular Engineering’s Helo Thrombectomy System for PE Studied in ENGULF

November 7, 2023—Endovascular Engineering, Inc. (E2) announced recently that initial results from its ENGULF study demonstrated successful outcomes among the first 15 patients evaluated in the trial using E2’s Helo thrombectomy system for the treatment of acute submassive pulmonary embolism (PE).

ENGULF is a single-arm, multicenter, feasibility study evaluating the safety and performance of the Helo device. The study was conducted under an FDA investigational device exemption. Helo for PE treatment is for investigational use only. It is not approved for commercial use and is not available for sale, advised the company.

The study’s national Principal Investigator is Jay Giri, MD, Director, Cardiovascular Catheterization Laboratories at the Hospital of the University of Pennsylvania in Philadelphia, Pennsylvania.

The company reported that an interim analysis of core lab-adjudicated outcomes among the first 15 patients treated at seven sites demonstrated a significant reduction in right ventricular/left ventricular ratio. There were no major adverse events reported for any of the patients through 30-day follow-up.

According to E2, the Helo thrombectomy system 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. The system’s low-profile design paired with this approach facilitates the extraction of a wide range of clot morphology, noted the company.

“The device has thus far been very safe, with no instances of pulmonary artery injury or cardiac injury noted,” commented Dr. Giri in E2’s press release. “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.”

Eric Secemsky, MD, Director of Vascular Intervention at Beth Israel Deaconess Medical Center in Boston, Massachusetts, added, “The Helo 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. 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.”