Akura Medical, a Shifamed portfolio company, announced today that the FDA granted its Katana system investigational device exemption (IDE).
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.
Additionally, Akura designed Katana with sensors that provide real-time pulmonary artery pressure data. This offers insights into procedure progress. The system’s sentinel console displays clot engagement and blood loss to inform the physician and potentially minimize uncertainty.
“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 minimized 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.”
