Akura Medical announced today it has initiated its first-in-human clinical study of the Akura mechanical thrombectomy platform. A press release notes that the Akura platform is a low-profile solution designed to easily access and efficiently remove large-volume, mixed-morphology clots, and eliminate the guesswork around the procedure. The initial five cases were performed in Georgia and marked the first use of mechanical thrombectomy for pulmonary embolism (PE) in the country.
Ehrin Armstrong (Advanced Heart & Vein Center, St Helena, USA) and S Jay Mathews (Bradenton Cardiology Center, Bradenton, USA) proctored the first procedures in Georgia. A prospective, single-arm, multicentre study will evaluate the safety and performance of the Akura mechanical thrombectomy platform for venous thromboembolism (VTE), the company reveals.
“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,” said Mathews. “The system’s integrated aspiration and maceration technology is equally efficient against mixed morphology thrombus without clogging the catheter. Additionally, physicians can inject contrast at any time to identify catheter position relative to the clot and capture the clot without crossing it.”
“Akura’s platform incorporates continuous monitoring of hemodynamic data which will change how we approach thrombus removal. This information can enable physicians to know when a substantial clot has been removed and provides actionable metrics around the procedure,” added Mahmood Razavi (Vascular & Interventional Specialists, Orange, USA).
The Akura platform will be showcased during Innovator’s Day at EuroPCR 2023 (16–19 May, Paris, France). Razavi will present on behalf of the company during the pulmonary embolism session beginning at 3:25pm CET on Monday 15 May. Akura Medical will be at booth M23 where PCR attendees can learn more about the platform.
“The first-in-human cases mark an important milestone for Akura in addressing the challenges physicians face with VTE today,” stated Murali Srivathsa, president and chief executive officer, Akura Medical. “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.”