Akura Medical, a Shifamed portfolio company, has received FDA approval for its Investigational Device Exemption (IDE) application to begin the QUADRA-PE study (NCT06672510). This pivotal trial will assess the safety and efficacy of the Katana Thrombectomy System in patients suffering from acute pulmonary embolism (PE).
The QUADRA-PE study is designed as a multi-center, international trial with plans to enroll up to 118 patients diagnosed with clinically significant acute PE across as many as 26 sites worldwide. The 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.
Katana Thrombectomy System Details
The Katana System incorporates several key features:
- A bi-directional, low-profile sheath designed to facilitate smoother navigation within complex vasculature, enabling contrast injection without catheter exchanges.
- High-velocity saline jets engineered to effectively break up clots regardless of their morphology, preventing catheter clogging for enhanced procedural efficiency.
- Sensors that provide real-time pulmonary artery pressure data, offering insights into the progress of the procedure.
- The Sentinel console, which displays clot engagement and blood loss information to inform the physician and potentially minimize uncertainty.
Expert Commentary
"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. He added that the Katana System was designed based on extensive physician feedback, addressing the need for a thrombectomy system that simplifies clot access, removes various clot types without clogging, and provides enhanced procedural feedback.
Pulmonary Embolism: A Critical Need
Pulmonary embolism occurs when a blood clot obstructs blood flow to the lungs, posing a life-threatening risk. It is the third leading cause of cardiovascular death in the United States, affecting approximately 900,000 individuals annually, with a mortality rate of 10-30% within one month of diagnosis.
