Akura Medical, a Shifamed portfolio company, has received FDA approval for its Investigational Device Exemption (IDE) application to commence the QUADRA-PE study (NCT06672510). This pivotal trial will evaluate the safety and effectiveness of the Katana™ Thrombectomy System in patients suffering from acute pulmonary embolism (PE).
The co-principal investigators for the QUADRA-PE study are Sanjum Sethi, MD, an Interventional Cardiologist at Columbia University Medical Center, and Ann Gage, MD, a Critical Care and Interventional Cardiologist at Tristar Centennial Medical Center.
Katana Thrombectomy System: Design and Functionality
The Katana System is designed to address the challenges associated with current PE treatment methods. It incorporates several key features:
- A bi-directional, low-profile sheath to facilitate navigation through complex vasculature and enable contrast injection without catheter exchanges.
- High-velocity saline jets engineered to break up clots of varying morphologies and prevent catheter clogging.
- Real-time pulmonary artery pressure sensors providing data for procedural insights.
- The Sentinel™ console, which displays clot engagement and blood loss information to aid physician decision-making.
QUADRA-PE Study Details
The QUADRA-PE study is a multi-center, international trial with plans to enroll up to 118 patients experiencing clinically significant acute PE across approximately 26 sites globally. The trial's primary effectiveness endpoint is the reduction in the right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure, as determined by CT angiography. The primary safety endpoint is the composite rate of major adverse events (MAEs) within 48 hours post-procedure.
The Burden of Pulmonary Embolism
Pulmonary embolism occurs when a blood clot obstructs blood flow to the lungs, and is a leading cause of cardiovascular death in the United States. It affects approximately 900,000 individuals annually, with a mortality rate of 10-30% within one month of diagnosis, according to the American Lung Association.
Company Statements
"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 of 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."
