A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF).

ABSTRACT:

Background

Despite advances in therapy options, pulmonary embolism (PE) continues to carry a high risk of mortality and morbidity. Currently, therapeutic options are limited with only 2 US Food and Drug Administration-cleared catheter-based embolectomy devices approved for the treatment of intermediate-risk PE. The novel Hēlo PE thrombectomy catheter (Endovascular Engineering, Inc) has a flexible and collapsible funnel with an internal agitator for a dual mechanism of treatment for acute PE. We sought to investigate the safety and feasibility of the novel Hēlo PE thrombectomy catheter in intermediate-risk PE.

Methods

A prospective, single-arm feasibility study evaluating the Hēlo PE catheter was performed in patients presenting with intermediate-risk PE. Patients underwent p

SUBMITTER: Kobayashi T 

PROVIDER: S-EPMC11307881 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature