Endovascular Engineering’s Helo Thrombectomy System Receives IDE Approval for ENGULF Pivotal Trial to Treat PE

January 11, 2024—Endovascular Engineering (E2), a developer of clot removal technologies for venous thromboembolism, announced FDA approval for an investigational device exemption (IDE) for the ENGULF United States pivotal trial. The study will evaluate the safety and effectiveness of the company’s Helo thrombectomy system in treating pulmonary embolism (PE).

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.

E2 noted that the IDE approval comes after the successful completion of the company’s 25-patient ENGULF feasibility study evaluating the safety and performance of the Helo device to treat PE. In Q4 2023, E2 announced initial results from the single-arm, multicenter study.

Jay Giri, MD, Director of the Cardiac Catheterization Laboratories at the University of Pennsylvania in Philadelphia, Pennsylvania, is national Principal investigator for the ENGULF feasibility study.

“We are excited to be at the forefront of this innovative procedure with the completion of the ENGULF feasibility study,” commented Dr. Giri in E2’s press release. “This significant achievement sets the stage for definitive results in the ENGULF pivotal trial. The Helo thrombectomy system represents a significant leap forward in PE treatment, and I am enthusiastic about investigating its full potential in the upcoming phase of the study.”

Dr. Klein added, “We intend to build upon the robust foundation of clinical success we’ve seen thus far, solidifying the Helo thrombectomy system’s role as a transformative force in the treatment of PE.”

According to the E2, the Helo technology removes clot using a dual-action approach that simultaneously combines the power of aspiration with advanced mechanical clot disruption.

The dual-action mechanism occurs within a self-expanding funnel, as the high-speed agitator actively engages and removes clot under physician-controlled suction. This approach efficiently and effectively extracts clot of mixed morphology. Helo is designed to provide the agility of a small-profile catheter with the capabilities of a large-bore device in a single-pass operation, stated the company.

The Helo thrombectomy system for PE is for investigational use only and is not approved for commercial use. Helo is not available for sale, advised E2.