Akura Medical, a Shifamed portfolio company focused on reshaping the landscape of venous thromboembolism (VTE) care, announced today the US Food and Drug Administration has approved its Investigational Device Exemption (IDE) application to initiate the QUADRA-PE study (NCT06672510) evaluating the Katana™ Thrombectomy System in patients with acute pulmonary embolism (PE). The co-principal investigators of the pivotal study are Sanjum Sethi, MD, Interventional Cardiologist at Columbia University Medical Center, and Ann Gage, MD, Critical Care and Interventional Cardiologist at Tristar Centennial Medical Center.
The Katana System consists of:
- A bi-directional, low-profile sheath designed to facilitate smoother navigation in complex vasculature and enable contrast injection without requiring catheter exchanges.
- High velocity saline jets that are engineered to effectively break up clots independent of morphology and prevent catheter clogging for procedural efficiency.
- Sensors that provide real-time pulmonary artery pressure data to provide insights into procedure progress.
- The Sentinel™ console, which displays clot engagement and blood loss to inform the physician and potentially minimize uncertainty.
The QUADRA-PE study is a multi-center, international trial designed to enroll 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 CT angiography. The primary safety endpoint is the composite rate of major adverse events (MAEs) within 48 hours post-procedure.
PE is life threatening and occurs when a blood clot travels through the bloodstream blocking blood flow to the lungs. It is the third leading cause of cardiovascular death in the US affecting approximately 900,000 patients annually, with 10-30% of patients dying within one month of diagnosis.
