VIVA Foundation: Late Breaking Clinical Trial Results at VEINS 2023 Highlights Akura Medical’s First-in-Human Study

LAS VEGAS, Oct. 30, 2023 – The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the results for the Late-Breaking Clinical Trials session at The VEINS conference, hosted at Wynn Las Vegas.

The VEINS (Venous Endovascular INterventional Strategies) is an annual venous education symposium that brings together a global, multispecialty faculty to present a comprehensive variety of talks and case presentations focused on venous care. Attendees include an audience of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists.

First-in-Human: Safety and Performance of the Akura Medical Thrombectomy System in Treating Venous Thromboembolism
Presented by: Jay Mathews, MD, MS

A first-in-human, prospective, single-arm study enrolled five patients at two sites in Tbilisi, Georgia, in March and April 2023 to evaluate the safety and performance of percutaneous mechanical thrombectomy using the Akura Medical Thrombectomy System (Akura Medical). The Akura system is a low-profile system that 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.

The key inclusion criteria included medically eligible patients aged > 18 years with clinical symptoms consistent with acute pulmonary embolism (PE) or sPESI (simplified PE Severity Index) ≥ 1, with symptom onset ≤ 14 days, proximal PE confirmed by CTA, a stable heart rate < 130 bpm prior to procedure, and systolic blood pressure ≥ 90 mm Hg, with a right ventricular/left ventricular (RV/LV) ratio > 0.9. Five patients were enrolled, treated, and followed through 7-day follow-up.

The patients successfully received treatment with the Akura thrombectomy system to remove pulmonary thrombus in the pulmonary vasculature. The average procedure time from anesthesia start to closure was 117 ± 50 minutes, with an average fluoroscopy time of 30 ± 21 minutes (range, 13-68 minutes). Total blood loss was 247 ± 80 mL on average, with 189 ± 120 mL of contrast used per procedure. After 48 hours, the RV/LV ratio decreased by 0.35 from 1.29 ± 0.15 to 0.94 ± 0.12 (P < .05; 26.85% reduction). 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.

About the VIVA Foundation

The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by the VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide.

Read the entire article on The Viva Foundation website.