Akura Medical's Katana System Receives FDA IDE Approval for Pulmonary Embolism Study
核心洞察
Akura Medical (搜索) received FDA IDE approval for its Katana thrombectomy system, allowing the start of the QUADRA-PE trial in acute pulmonary embolism (搜索) patients.
The QUADRA-PE study aims to enroll 118 patients across 26 global sites, assessing the Katana system (搜索)'s effectiveness in reducing right ventricular/left ventricular ratio.
Katana system (搜索) features a bi-directional sheath, high-velocity saline jets for clot disruption, and real-time pulmonary artery pressure sensors for procedural feedback.
Akura Medical (搜索), a Shifamed portfolio company, has secured FDA Investigational Device Exemption (IDE) approval for its Katana thrombectomy system. This clearance paves the way for the QUADRA-PE study, which will evaluate the system's safety and efficacy in patients suffering from acute pulmonary embolism (搜索) (PE). The trial, co-led by Dr. Sanjum Sethi from Columbia University Medical Center and Dr. Ann Gage at Tristar Centennial Medical Center, marks a significant step forward in the development of next-generation PE treatment options.
QUADRA-PE Study Design
The QUADRA-PE study is set to enroll up to 118 patients diagnosed with clinically significant acute PE across approximately 26 sites worldwide. The study's primary effectiveness endpoint is the reduction in the right ventricular/left ventricular (RV/LV) ratio, a key indicator of cardiac strain caused by PE, measured via CT angiography from baseline to 48 hours post-procedure. The primary safety endpoint focuses on the composite rate of major adverse events (MAEs) occurring within the initial 48 hours following the procedure.
Katana System Features
The Katana system (搜索) incorporates several innovative design elements to improve thrombectomy procedures. Its bi-directional, low-profile sheath is engineered to facilitate smoother navigation through complex vasculature, enabling contrast injection without the need for catheter exchanges. The system also utilizes high-velocity saline jets designed to effectively break up clots, regardless of their morphology, while preventing catheter clogging to enhance procedural efficiency.
Real-time Feedback and Control
Furthermore, the Katana system (搜索) is equipped with sensors that provide real-time pulmonary artery pressure data, offering physicians immediate insights into the progress of the procedure. The system's sentinel console displays clot engagement and blood loss information, potentially minimizing uncertainty and informing clinical decision-making during the intervention.
Addressing Unmet Needs in PE Treatment
"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 (搜索)," said Murali Srivathsa, president and CEO of Akura Medical (搜索). He added, "We designed the Katana System (搜索) 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."