FDA Grants Investigational Device Exemption for Endovascular Engineering’s Hēlo Thrombectomy Device

The FDA has authorized an investigational device exemption endorsement for the trial conducted by Endovascular Engineering, exploring the efficacy of its Hēlo Thrombectomy device in addressing pulmonary embolism.  

Pulmonary embolism is a medical condition characterized by the blockage of one or more arteries in the lungs, typically caused by blood clots that travel from other parts of the body.  

The trial comes after the ENGULF viability analysis conducted by the organization. Endovascular Engineering disclosed favourable initial outcomes from the small trial.  

The viability investigation showcased a noteworthy decrease in the proportion of right ventricular to left ventricular, and the FDA acknowledges this ratio as a measure of extended life expectancy.   

The Hēlo system concurrently suctions and mechanically breaks down the clot; according to Endovascular Engineering, the technology achieves clot removal in a one-pass procedure.  

Dr. Andrew Klein, the primary researcher of the pivotal study, stated: “We intend to build upon the robust foundation of clinical success we’ve seen thus far, solidifying the Hēlo thrombectomy system’s role as a transformative force in the treatment of pulmonary embolism.”  

© Copyright 2010-2021 Zenopa LTD. All Rights Reserved.