IDE means Akura can begin the QUADRA-PE study evaluating the thrombectomy system in patients with acute pulmonary embolism (PE). Dr. Sanjum Sethi (Columbia University Medical Center) and Dr. Ann Gage (Tristar Centennial Medical Center) serve as co-principal investigators.

The company expects QUADRA-PE to enroll up to 118 patients with clinically significant acute PE at up to 26 global sites. It has a primary effectiveness endpoint of reduction in right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure as assessed by CT angiography. The primary safety endpoint is the composite rate of major adverse events (MAEs) within 48 hours post-procedure.

Los Gatos, California-based company designed its Katana system with a bi-directional, low-profile sheath. It facilitates smoother navigation in complex vasculature and enables contrast injection without requiring catheter exchanges. Additionally, the system features high-velocity saline jets. The company engineered these to effectively break up clots independently of morphology and prevent catheter clogging for procedural efficiency.