California-based Akura Medical, a Shifamed portfolio company involved in venous thromboembolism (VTE) care, announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application to begin the QUADRA-PE study assessing the Katana Thrombectomy System in patients with acute pulmonary embolism (PE).

The Katana System consists of: a bi-directional, low-profile sheath engineered to facilitate smoother navigation in complex vasculature and allow contrast injection without requiring catheter exchanges; high velocity saline jets that are designed to effectively break up clots independent of morphology and prevent catheter clogging for procedural efficiency; sensors that provide real-time pulmonary artery pressure data to provide insights into procedure progress; and the Sentinel console which displays clot engagement and blood loss to inform the physician and potentially reduce uncertainty.

A multi-centre, international trial, QUADRA-PE will enrol up to 118 patients with clinically significant acute PE at up to 26 sites globally. The primary effectiveness endpoint is reduction in right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure, as evaluated by CT angiography. The study's primary safety endpoint is the composite rate of major adverse events (MAEs) within 48 hours post-procedure.