EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Safety and effectiveness of the Vertex Pulmonary Embolectomy System in acute intermediate-risk pulmonary embolism: the SPIRARE II pivotal trial
By Sayfo S, Stępniewski J, Gallo V and 11 others.
Abstract
Background
Percutaneous aspiration thrombectomy can rapidly reduce afterload in acute pulmonary embolism (PE), but catheter stiffness and instability may limit access and prevent effective right ventricle (RV) unloading. The Vertex Pulmonary Embolectomy System with Transforming Fixation (TFX) technology is designed to address current limitations of existing catheter-based systems by separating the flexibility necessary for safe navigation from the support that is essential for procedural control.
Aims
We aimed to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System for mechanical aspiration thrombectomy in acute intermediate-risk PE.