Endovascular Engineering, a medical device company involved with clot removal technologies for venous thromboembolism (VTE), has announced the enrolment and treatment of the first patient in the pivotal phase of its ENGULF US clinical trial.
This IDE trial will further evaluate the safety and efficacy of the Hēlo pulmonary embolism (PE) thrombectomy system, a first-of-its-kind technology, for the treatment of PE. This initial treatment, led by Malcolm Foster (Tennova Turkey Creek Medical Center, Farragut, USA) represents a step forward on the path to introducing the Hēlo PE system to the US market.
Enrolment of the first patient in the ENGULF pivotal cohort follows the completion of the 25-patient feasibility phase of the study. All patients in the pivotal trial will be treated with the latest version of the Hēlo PE thrombectomy system, equipped with a new accessory device designed to optimise clot engagement and blood loss management. “The integration of this new feature into the Hēlo system marks an impressive advancement, providing invaluable feedback that supports safe navigation for engaging target clot and helps to minimise blood loss throughout thrombectomy procedures,” noted Foster.
Mike Rosenthal, CEO of Endovascular Engineering, emphasised the importance of initiating the ENGULF pivotal IDE trial stating, “This first procedure represents a critical milestone for our company as the ENGULF trial is a reflection of our commitment to advancing the field of thrombectomy and has been initiated ahead of schedule.” Through clinical collaborations with leading medical institutions and clinicians like Foster, Endovascular Engineering remains committed to improving patient outcomes and revolutionizing thrombectomy treatment.
