The US Food and Drug Administration (FDA) has approved Akura Medical’s investigational device exemption (IDE) application to initiate the QUADRA-PE study evaluating the Katana thrombectomy system in patients with acute pulmonary embolism (PE).
The co-principal investigators of the pivotal study are Sanjum Sethi (Columbia University Medical Center, New York, USA) and Ann Gage (Tristar Centennial Medical Center, Nashville, USA).
“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,” said Murali Srivathsa, president and CEO, Akura Medical. “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.”
The Katana System consists of a bidirectional, low-profile sheath designed to facilitate smoother navigation in complex vasculature and enable contrast injection without requiring catheter exchanges. It also features high velocity saline jets that are engineered to effectively break up clots independent of morphology and prevent catheter clogging for procedural efficiency and sensors that provide real-time pulmonary artery pressure data to provide insights into procedure progress.
QUADRA-PE is a multicentre, international trial designed to enrol up to 118 patients with clinically significant acute PE at up to 26 sites globally. The primary effectiveness endpoint is the reduction in right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure as assessed by computed tomography (CT) angiography. The primary safety endpoint is the composite rate of major adverse events (MAEs) within 48 hours post-procedure.
