Akura Medical, a Shifamed portfolio company, has received the US Food and Drug Administration (FDA) approval for an Investigational Device Exemption (IDE) trial of its Katana Thrombectomy System.
This approval allows the company to begin the QUADRA-PE study (NCT06672510) to evaluate the Katana Thrombectomy System in patients with acute pulmonary embolism (PE).
Sanjum Sethi, an interventional cardiologist at Columbia University Medical Center, and Ann Gage, a critical care and interventional cardiologist at Tristar Centennial Medical Center, will serve as co-principal investigators.
The QUADRA-PE study is a multi-centre, international trial aiming to enrol up to 118 patients with clinically significant acute PE across 26 global sites.
The primary effectiveness endpoint is the reduction in the right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure, assessed by CT angiography.
The primary safety endpoint is the composite rate of major adverse events (MAEs) within 48 hours after the procedure.
Akura Medical president and CEO Murali Srivathsa said: “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.
“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.”
California-based Akura Medical has designed the investigational Katana Thrombectomy System using several advanced features to improve the treatment of PE.
It includes a bi-directional, low-profile sheath that facilitates smoother navigation through complex vasculature and enables contrast injection without the need for catheter exchanges.
The system also incorporates saline jets, engineered to break up clots effectively, regardless of their morphology, while preventing catheter clogging to enhance procedural efficiency.
Additionally, real-time sensors provide pulmonary artery pressure data, offering insights into the progress of the procedure.
The Sentinel console displays clot engagement and blood loss, helping guide the physician and potentially reducing procedural uncertainty.
Akura Medical is a privately held portfolio company focused on addressing venous thromboembolism (VTE).
In October 2023, the company raised $35m in a Series B financing round to support its flagship Katana System.
