Shifamed portfolio company Akura Medical has commenced its first clinical trial involving human subjects, with its mechanical thrombectomy platform.
Akura has designed the prospective, single-arm and multi-centre study to assess the safety and performance of the Akura Mechanical Thrombectomy Platform for venous thromboembolism (VTE).
The first five cases have been performed in the Republic of Georgia, marking the first application of mechanical thrombectomy for pulmonary embolism in the country.
Dr Ehrin Armstrong of the Advanced Heart and Vein Centre in Colorado and Dr Jay Mathews of the Bradenton Cardiology Centre in Florida supervised the first procedures in Georgia.
In a statement, Dr Mathews said: “The Akura platform is differentiated with a state-of-the-art design that aims to address the major challenges of today’s options, specifically catheter clogging and having to confirm contact with the clot prior to initiating removal.”
The new low-profile solution will help easily access and effectively remove large-volume, mixed-morphology clots besides avoiding the guesswork around the procedure.
The product is currently undergoing research and development and has not yet received clearance from the US Food and Drug Administration, CE mark approval or authorisation for global sales.
Akura Medical president and CEO Murali Srivathsa said: “The first-in-human cases mark an important milestone for Akura in addressing the challenges physicians face with VTE today.
“I would like to thank the entire team for their seamless execution and our physician advisors for their expertise and guidance in designing and supporting this initial clinical experience. We look forward to sharing additional details about the high-performance Akura platform at PCR next week.”