Endovascular Engineering (E2) today announced positive safety and feasibility results from a clinical trial of its Hēlo PE thrombectomy system.
The company presented positive safety and feasibility results at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions. It simultaneously published the results in JSCAI.
Menlo Park, California-based E2’s ENGULF trial is a prospective, multi-center, feasibility study evaluating Hēlo. It looks at Hēlo in the treatment of acute pulmonary embolism (PE) under an FDA investigational device exemption (IDE). The company set a primary efficacy outcome of the percent difference in the pre-to-post procedural right ventricle–to–left ventricle (RV/LV) ratios, the FDA-recognized metric associated with increase morbidity and mortality.
The trial had primary and secondary safety outcomes defined as 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 post-procedure.
All 25 patients from eight centers underwent successful embolectomy. E2 reported no major adverse events at 48 hours and no deaths at 30 days.
E2 designed Hēlo to remove clot with a patented, dual-action approach. This approach simultaneously combines the power of aspiration with advanced mechanical clot disruption. The dual-action mechanism occurs within a self-expanding funnel. At this point, a high-speed agitator actively engages and removes clot under physician-controlled suction.
Hēlo operates with the agility of a small-profile catheter with teh capabilities of a large-bore device in a single-pass operation.
“The ENGULF trial’s positive results are indicative of our clinical leadership and our unwavering commitment to innovation and patient care. As a purpose-built platform for the treatment of PE, the Hēlo System is now supported by more clinical evidence than any other emerging company,” said Mike Rosenthal, E2 CEO. “We are proud to lead PE treatment innovation with meaningful advancements to transform endovascular care.”
