Endovascular Engineering Begins ENGULF Pivotal Trial of Helo Thrombectomy System in PE

February 20, 2024—Endovascular Engineering, Inc. (E2), a medical device company focused on clot removal technologies for venous thromboembolism, announced the enrollment and treatment of the first patient in the pivotal phase of its ENGULF United States clinical trial.

The trial will evaluate the safety and efficacy of the company’s Helo thrombectomy system for the treatment of pulmonary embolism (PE) to support an application for FDA approval of the device. On January 11, the company announced FDA approval for an investigational device exemption (IDE) for the ENGULF United States pivotal trial.

The initial treatment in the trial was led by Malcolm Foster, MD, Director of the Cardiac Catheterization Lab at Tennova Turkey Creek Medical Center in Farragut, Tennessee. The national Principal Investigator for the ENGULF pivotal study is Andrew Klein, MD, an interventional cardiologist at the Piedmont Heart Institute at Piedmont Hospital in Atlanta, Georgia.

According to E2, enrollment of the first patient in the ENGULF pivotal cohort comes after the completion of the 25-patient feasibility phase of the study.

In Q4 2023, the company announced initial results from the single-arm multicenter feasibility phase of ENGULF. The data demonstrated successful outcomes among the first 15 patients evaluated in the trial using the Helo system for the treatment of acute submassive PE.

E2 noted that all patients in the pivotal trial will be treated with the latest version of the Helo PE thrombectomy system, which is equipped with a new accessory device designed to optimize clot engagement and blood loss management.

“The integration of this new feature into the Helo system marks an impressive advancement, providing invaluable feedback that supports safe navigation for engaging target clot and helps to minimize blood loss throughout thrombectomy procedures,” commented Dr. Foster in E2’s press release.