Endovascular Engineering, Inc. Announces Positive Initial Results in ENGULF Study for HēloTM Thrombectomy System

ENGULF Study utilizing next generation technology in targeting pulmonary embolism 

Menlo Park, Calif., October 31, 2023 – Endovascular Engineering (“E2”), a mission driven,  venture-backed, medical device company focused on the development and deployment of next  generation clot removal technologies, announced today positive initial results from its ENGULF  study. The study demonstrated successful outcomes among the first 15 patients evaluated in  the trial using the Hēlo Thrombectomy System for the treatment of acute sub-massive  pulmonary embolism. 

The ENGULF Study is a single-arm, multi-center, feasibility study evaluating the safety and  performance of the Hēlo Thrombectomy System, conducted under an FDA IDE. An interim  analysis of core lab adjudicated outcomes among the first 15 patients treated at seven sites  

demonstrated a significant reduction in right ventricular to left ventricular ratio (RV:LV), the FDA recognized metric associated with increased morbidity and mortality. There were no major  adverse events (MAE) reported for any of the patients through 30-day follow up. 

The Hēlo Thrombectomy System is next generation technology that 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. Its low-profile design paired with this innovative approach facilitates the extraction of a  wide range of clot morphology. 

“The Hēlo 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,” said Eric Secemsky, MD, MSc, Director of Vascular Intervention, at Beth  Israel Deaconess Medical Center. “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.” 

“The device has thus far been very safe with no instances of pulmonary artery injury or cardiac  injury noted,” said the national principal investigator, Jay Giri, MD, MPH, Director,  Cardiovascular Catheterization Laboratories at the Hospital of the University of Pennsylvania. 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.”

“We are very pleased with the initial clinical experience observed during the ENGULF feasibility  study and the tangible progress in our mission to provide a differentiated clinical solution to  patients and physicians,” said Mike Rosenthal, CEO of E2. “The Hēlo Thrombectomy System is  performing as expected in this clinical study. We look forward to additional enrollment in the  ENGULF study and the continuation into the pivotal trial phase.” 

About Endovascular Engineering, Inc. 

Endovascular Engineering, Inc. (“E2”), is a mission driven, venture-backed company focusing  on the development and deployment of next generation clot removal technologies that target  venous thromboembolism. The Company’s HēloTM Thrombectomy System represents a  significant advancement in thrombectomy procedures, through its unique dual-action  technology. Combining powerful aspiration with advanced mechanical clot disruption within an  atraumatic funnel tip, enables precise, controlled clot extraction in a singular pass. 

The Company was established by Santé Ventures and Inventure Group, and is  additionally supported by Cordis and another strategic investor. The core of the E2  technology is based on research performed by E2 Founder, Luis Savastano, MD, PhD, at  the University of Michigan in neurosurgery and mechanical engineering, additionally  supported by MTRAC, Coulter, Innovation Partnerships and the Michigan Biomedical  Venture Fund. 

The Hēlo Thrombectomy System for pulmonary embolism is for Investigational Use only  and is not approved for commercial use.

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