Akura Medical's Katana Thrombectomy System Receives FDA IDE Approval for Pulmonary Embolism Trial
核心洞察
Akura Medical (搜索)'s Katana thrombectomy system (搜索) has received FDA IDE approval to begin the QUADRA-PE study for acute pulmonary embolism (搜索) (PE).
The QUADRA-PE trial will enroll up to 118 patients across 26 global sites to evaluate the Katana system's effectiveness and safety.
The Katana system features a bidirectional sheath, high-velocity saline jets for clot disruption, and real-time pulmonary artery pressure sensors.
Akura Medical (搜索) has received U.S. Food and Drug Administration (FDA) approval for its Investigational Device Exemption (IDE) application to commence the QUADRA-PE study. This pivotal trial will evaluate the Katana thrombectomy system (搜索) in patients suffering from acute pulmonary embolism (搜索) (PE).
The QUADRA-PE study, a multicenter, international trial, plans to enroll up to 118 patients with clinically significant acute PE across as many as 26 sites worldwide. Sanjum Sethi (Columbia University Medical Center) and Ann Gage (Tristar Centennial Medical Center) will serve as the co-principal investigators.
The Katana System is engineered with a bidirectional, low-profile sheath to ease navigation through complex vasculature and allow contrast injection without catheter exchanges. High-velocity saline jets are designed to break up clots of varying morphologies and prevent catheter clogging, enhancing procedural efficiency. Integrated sensors provide real-time pulmonary artery pressure data, offering insights into the procedure's progress.
The primary effectiveness endpoint of the QUADRA-PE study is the reduction in the right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure, as determined by computed tomography (CT) angiography. The primary safety endpoint is the composite rate of major adverse events (MAEs) within 48 hours post-procedure.
"The IDE approval of QUADRA-PE marks a significant milestone in the company’s journey toward providing physicians with a next-generation solution for treating acute pulmonary embolism (搜索)," stated Murali Srivathsa, president and CEO of Akura Medical (搜索). "We designed the Katana System based on extensive feedback from physicians who shared their need for a thrombectomy system that minimised the difficulty of getting to the clot, removed all types of clots without catheter clogging and provided greater procedural feedback. We look forward to working with our clinical investigators to demonstrate our system’s efficacy."