Akura Medical Secures FDA Approval for US Pivotal Trial in Pulmonary Embolism
QUADRA-PE study will evaluate the safety and effectiveness of the Katana™ Thrombectomy System
LOS GATOS, Calif., Nov. 4, 2024 /PRNewswire/ -- 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 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."
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.1
About Akura Medical, Inc.
Akura Medical, a privately held portfolio company of Shifamed LLC, is a medical technology company dedicated to addressing venous thromboembolism (VTE). Our flagship product, the Katana™ Thrombectomy System, is poised to redefine pulmonary embolism (PE) treatment standards by enabling enhanced removal of diverse clot types more efficiently. The Katana Thrombectomy System embodies our mission to reshape the landscape of VTE care and make a lasting impact on the lives of patients worldwide. To learn more about Akura Medical, visit www.akuramed.com.
*The Katana System is for Investigational Use only and is not cleared for sale in the USA. Not approved for sale in any country.
About Shifamed, LLC
Founded by serial entrepreneur Amr Salahieh, Shifamed is a highly specialized medical innovation hub focused on developing solutions that accelerate time to market, reduce risk, increase impact, and forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.
Reference:
- American Lung Association. Learn About Pulmonary Embolism Fact Sheet. January 2023
