Akura Begins Pivotal Trial of Katana Thrombectomy System in Pulmonary Embolism

February 4, 2025—Akura Medical, Inc., a privately held portfolio company of Shifamed LLC that is developing treatments for venous thromboembolism (VTE), announced that the first patient was enrolled in the QUADRA-PE study evaluating the company’s Katana thrombectomy system in patients with acute pulmonary embolism (PE).

According to the company, the multicenter, international QUADRA-PE trial is 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 ratio from baseline to 48 hours post procedure as assessed by CTA. The primary safety endpoint is the composite rate of major adverse events within 48 hours post procedure, noted the company.

The initial procedure in the trial was performed by Samuel Horr, MD, Director of Cardiovascular Research at TriStar Centennial Medical Center in Nashville, Tennessee

“TriStar Centennial is thrilled to be a part of research trials that hold the potential to deliver better care to patients,” commented Dr. Horr in the company’s press release. “With this trial, the hope is to provide physicians with continuous, real-time pulmonary artery pressure readings throughout the entire procedure to streamline the removal of the blood clot.”

Sanjum Sethi, MD, and Ann Gage, MD, are coprincipal investigators of the QUADRA-PE trial.

Dr. Sethi is an interventional cardiologist at Columbia University Medical Center in New York, New York. Dr. Gage specializes in critical care and interventional cardiology at TriStar Centennial Medical Center.

“One of the biggest challenges in thrombectomy procedures for PE is determining when you’ve successfully removed the thrombus entirely, as incomplete removal can may lead to suboptimal outcomes,” stated Dr. Sethi, in the press release. “The Katana system’s display of real-time pressure data represents a significant advancement, providing physicians with clinically useful insights during the procedure.”

Dr. Gage added, “PEs can be life-threatening and demand swift and effective intervention. Meaningful strides have been made in the thrombectomy landscape, but challenges remain in navigating complex vasculature and simplifying decision-making. I am incredibly excited to be involved in this study as it represents a significant milestone in the forward trajectory of PE treatment.”

Akura Medical stated that Katana is an intelligent thrombectomy system designed to remove diverse clot types, optimize catheter delivery, and provide interoperative feedback. The device is for investigational use only and is not cleared for sale in the United States and not approved for sale in any country.

As outlined in the company’s press release, the Katana system includes the following:

• A bidirectional, 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 to potentially minimize uncertainty.