Akura Medical has enrolled the first subject in the multi-centre QUADRA-PE trial, which is assessing its flagship Katana thrombectomy system in treating acute pulmonary embolism (PE) patients.
TriStar Centennial Medical Center’s cardiovascular research director Dr Samuel Horr performed the procedures.
The international trial aims to enrol up to 118 subjects with clinically significant acute PE at up to 26 worldwide sites.
The trial’s primary effectiveness endpoints include the composite major adverse events (MAEs) rate within 48 hours post-procedure, and a decrease in the right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours after the procedure, as evaluated by computed tomography (CT) angiography.
The system includes a low-profile, bi-directional sheath tailored to navigate complex vasculature smoothly, allowing for contrast injection without the need for catheter exchanges.
It features ‘high-velocity’ saline jets designed for clot breaking, regardless of its form, and helps eliminate catheter blockages.
The sensors-equipped system delivers real-time data on pulmonary artery pressure, offering insights into the procedure's progression.
Katana’s Sentinel Console provides critical information on clot engagement and blood loss, helping physicians make informed decisions and potentially reduce procedural uncertainty.
QUADRA-PE trial co-principal investigator and Columbia University Medical Center interventional cardiologist Sanjum Sethi said: "One of the biggest challenges in thrombectomy procedures for PE is determining when you've successfully removed the thrombus entirely, as incomplete removal can lead to suboptimal outcomes.
"The Katana System's display of real-time pressure data represents a significant advancement, providing physicians with clinically useful insights during the procedure."
A Shifamed portfolio company, Akura focuses on solutions for venous thromboembolism (VTE). The Katana system is currently in the investigational phase and is not yet available for sale.
In October 2023, the company secured $35m in Series B financing for its mechanical thrombectomy platform.
