Akura’s Mechanical Thrombectomy Platform Used in FIH Study for VTE

May 10, 2023—Akura Medical, a privately held portfolio company of Shifamed LLC, announced it has initiated its first-in-human clinical study of the Akura mechanical thrombectomy platform. The prospective, single-arm, multicenter study will evaluate the safety and performance of the Akura platform for treatments of venous thromboembolism.

According to the company, the Akura mechanical thrombectomy 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 company stated that the initial five cases were performed in the Republic of Georgia and marked the first use of mechanical thrombectomy for pulmonary embolism in the country. The procedures were proctored by Ehrin Armstrong, MD, of Advanced Heart & Vein Center in Deer Park, Colorado, and S. Jay Mathews, MD, of Bradenton Cardiology Center in Bradenton, Florida.

“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,” commented Dr. Mathews in the company’s press release. “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.”

Mahmood Razavi, MD, from Vascular & Interventional Specialists of Orange County in Orange, California, added, “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.”

The company advised that the Akura platform will be showcased during PCR Innovator’s Day on Monday, May 15, when Dr. Razavi will present on behalf of the company during the pulmonary embolism session beginning at 3:25 pm CEST. EuroPCR will be held May 16-19, 2023, in Paris, France.