Akura Medical, a Shifamed portfolio company focused on a differentiated approach delivering an effective solution to address the major challenges of venous thromboembolism (VTE), announced today it has initiated its first-in-human clinical study of the Akura Mechanical Thrombectomy Platform.
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 5 cases were performed in the Republic of Georgia and marked the first use of mechanical thrombectomy for pulmonary embolism (PE) in the country.
Additionally, Ehrin Armstrong, MD, FACC, FSCAI, FSVM, Advanced Heart & Vein Center in Colorado, and S. Jay Mathews, MD, FACC, FSCAI, Bradenton Cardiology Center in Florida, proctored the historic first procedures in Georgia. The prospective, single-arm, multi-center study will evaluate the safety and performance of the Akura Mechanical Thrombectomy Platform for VTE.
“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 Dr. 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, MD, FSIR, FSVM, Vascular & Interventional Specialists of Orange County in California.
The Akura platform will be showcased during PCR Innovator’s Day as it was chosen through a highly competitive selection process. Dr. Razavi will present on behalf of the company during the Pulmonary Embolism session beginning at 3:25 pm CET on Monday, May 15, 2023, in Paris, France. Akura Medical will be at booth M23 where PCR attendees can learn more about the platform.
While the use of mechanical thrombectomy devices has been increasing, current options are procedurally complex, use large bore devices, are frequently inefficient, and have difficulty reaching the target anatomy. VTE occurs when a blood clot, often formed in a deep vein in the leg, severely restricts or blocks blood flow to the lungs, which can be life-threatening. As many as 900,000 people are affected annually in the US, with sudden death being the first symptom in approximately 25% of people with VTE.1
“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.”
