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MENLO PARK, Calif., May 6, 2024 /PRNewswire/ — Endovascular Engineering, Inc. (“E2”), a pioneering medical device company at the forefront of advancing clot removal technologies for venous thromboembolism (VTE), proudly announced positive safety and feasibility results from its ENGULF US clinical trial as late-breaking science at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions and simultaneously published in JSCAI.
The ENGULF trial is a prospective, multi-center, feasibility study evaluating the safety and performance of the Hēlo™ PE Thrombectomy System for the treatment of acute pulmonary embolism (PE), conducted under an FDA IDE in the US. Patients underwent a pre- and 48-hour post-procedural computed tomography (CT) scan. The primary efficacy outcome was 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 primary and secondary safety outcomes were 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. The mean RV/LV ratio was 1.53±0.27 at baseline and 1.15±0.18 at 48 hours post-procedure (23.2%±12.8% change). Of note, there were no major adverse events (MAE) at 48 hours and no deaths at 30 days.
“The Hēlo PE Thrombectomy System has been carefully designed to address what clinicians are seeking in next-generation technology for the treatment of pulmonary embolism,” said Jay Giri, MD, MPH, Director of the Cardiovascular Catheterization Laboratories at the Hospital of the University of Pennsylvania and the national principal investigator of the ENGULF feasibility trial. “The clinical evidence demonstrated in the ENGULF feasibility study supports the utility of the Hēlo’s novel features. I look forward to the development of additional clinical evidence as we continue to enroll in the US pivotal trial.”
Mike Rosenthal, CEO of E2, highlighted the significance of these results, “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. We are proud to lead PE treatment innovation with meaningful advancements to transform endovascular care.”
About Hēlo Thrombectomy System
The Hēlo Thrombectomy System is a first of its kind technology that removes clot with its patented 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 innovative approach efficiently and effectively extracts clot of mixed morphology. Hēlo operates with the agility of a small profile catheter yet boasts the capabilities of a large bore device in a single-pass operation, redefining thrombectomy.
About Endovascular Engineering, Inc.
Endovascular Engineering, Inc. (“E2”), is a mission driven, venture-backed company focusing on the development and deployment of groundbreaking clot removal technologies that target venous thromboembolism (VTE).
The Hēlo PE Thrombectomy System for pulmonary embolism is for Investigational Use only and is not approved for commercial use. Hēlo Thrombectomy System is not available for sale.
For more information, please visit www.endovascularengineering.com or contact [email protected]. Follow us on LinkedIn @EndovascularEngineering.
SOURCE Endovascular Engineering, Inc.
