Akura Receives IDE Approval for QUADRA-PE Pivotal Trial of Katana System

November 8, 2024—Akura Medical, a Shifamed portfolio company focused on venous thromboembolism care, announced recently that the FDA has approved its investigational device exemption (IDE) application to initiate the QUADRA-PE pivotal study of the company’s Katana thrombectomy system in patients with acute pulmonary embolism (PE).

According to the company, the QUADRA-PE study is a multicenter, international trial designed to enroll up to 118 patients with clinically significant acute PE at up to 26 sites globally.

The study’s primary effectiveness endpoint is the reduction in right ventricular/left ventricular ratio from baseline to 48 hours postprocedure as assessed by CT angiography. The primary safety endpoint is the composite rate of major adverse events within 48 hours postprocedure, stated the company.

The study’s coprincipal investigators are Sanjum Sethi, MD, and Ann Gage, MD. Dr. Sethi is an interventional cardiologist at Columbia University Medical Center in New York, New York. Dr. Gage is a critical care and interventional cardiologist at Tristar Centennial Medical Center in Nashville, Tennessee.

Akura Medical stated that the Katana system is composed of a bidirectional, low-profile sheath that navigates complex vasculature and enables contrast injection without catheter exchanges; high velocity saline jets that break up clots independent of morphology and prevent catheter clogging; sensors that provide real-time pulmonary artery pressure data; and the company’s Sentinel console that displays clot engagement and blood loss.

The Katana system is for investigational use only and is not cleared for sale in the United States or in any country, advised Akura Medical.