Akura Medical’s Thrombectomy System Evaluated in FIH Study for Treating VTE

October 30, 2023—A first-in-human (FIH), prospective, single-arm study of the safety and performance of percutaneous mechanical thrombectomy using Akura thrombectomy system (Akura Medical) was conducted at two sites in Tbilisi, Georgia, in March and April 2023.

The low-profile Akura system for treating venous thromboembolism combines targeted clot removal with a platform capable of providing objective data on hemodynamics to help clinicians understand the relationship between thrombus removal and alleviation of pulmonary artery pressures.

Jay Mathews, MD, presented the findings from the FIH study at The VEINS (Venous Endovascular Interventional Strategies) annual venous education symposium held by The VIVA Foundation on October 28-30 in Las Vegas, Nevada.

As outlined in The VEINS press release, the study’s key inclusion criteria included:

• Medically eligible patients aged > 18 years with clinical symptoms consistent with acute pulmonary embolism (PE) or simplified PE Severity Index (sPESI) ≥ 1
• Symptom onset ≤ 14 days
• Proximal PE confirmed by CT angiography
• A stable heart rate < 130 bpm before the procedure
• Systolic blood pressure ≥ 90 mm Hg
• Right ventricular/left ventricular (RV/LV) ratio > 0.9

The study enrolled five patients who were treated and monitored through 7-day follow-up.

As summarized in The VEINS press release, the five patients received treatment with the Akura thrombectomy system to remove pulmonary thrombus in the pulmonary vasculature with an average procedure time from start of anesthesia to closure was 117 ± 50 minutes. Average fluoroscopy time was 30 ± 21 minutes (range, 13-68 minutes).

Total blood loss was 247 ± 80 mL on average, and amount of contrast used was 189 ± 120 mL per procedure.

After 48 hours, the RV/LV ratio decreased by 0.35 (26.85%), from 1.29 ± 0.15 to 0.94 ± 0.12 (P < .05).

Through 7-day follow-up, there were no deaths, device-related major bleeding, or device-related adverse events.

The Akura thrombectomy system for PE appears safe, and preliminary evidence shows that this platform technology leads to a significant reduction in RV/LV ratio and thrombus burden, reported Dr. Mathews at The VEINS symposium.

Akura Medical, which is a privately held portfolio company of Shifamed LLC, announced the commencement of the FIH clinical study on May 10, 2023.