Ventiv Scientific today announced the successful completion of its first-in-human (FIH) clinical cases utilizing the V-PULSE™ Mechanical Thrombectomy System, a novel platform designed to remove blood clots from the peripheral vasculature. The system aims to address challenges in mechanical thrombectomy, a critical treatment for thrombotic and embolic vascular diseases such as Deep Vein Thrombosis (DVT), Acute Limb Ischemia (ALI), Critical Limb Ischemia (CLI), Chronic Total Occlusions (CTO), and Pulmonary Embolism (PE).
Mechanical thrombectomy procedures restore blood flow, relieve symptoms, preserve limbs, and save lives. However, conventional aspiration systems rely solely on continuous vacuum generated by syringes or electromechanical pumps, which can lead to significant blood loss and catheter clogging. The V-PULSE system offers real-time control over aspiration force at the catheter tip, enabling physicians to rapidly initiate, stop, increase, or decrease aspiration. This design potentially minimizes clogging and reduces procedural blood loss.
"The V-PULSE system removed significant clot burden and provided immediate visual confirmation of thrombus capture through its integrated filtration technology," said Makmood Razavi, M.D., of St. Joseph Heart & Vascular Center in Orange, CA. "In our initial experience, the device demonstrated excellent control and procedural efficiency. Effective clot removal is critical for patients suffering from venous and arterial thrombotic disease, where delayed treatment can lead to serious complications."
John O'Connor, President of Ventiv Scientific, emphasized the platform's advantages: "Aspiration thrombectomy systems can remove substantial volumes of blood while attempting to extract thrombus. The V-PULSE platform was engineered to provide physicians with procedural control, optimize aspiration efficiency, and potentially reduce blood loss while remaining compatible with aspiration pumps already available in hospitals today."
The V-PULSE system is part of Ventiv Scientific's growing thrombectomy portfolio, which includes the FDA-cleared Control Aspire® Mechanical Thrombectomy System, featuring over-the-wire catheters for peripheral use and rapid-exchange catheter systems for peripheral and coronary applications. Additionally, the company is developing next-generation technologies, including a proprietary multi-strut thrombectomy basket retrieval platform. These investigational products have not been cleared by the U.S. Food and Drug Administration.
For business and technology leaders, this announcement signals a potential shift in standard care for thrombotic conditions. The V-PULSE system's enhanced control could reduce complications, shorten procedure times, and lower healthcare costs. As Ventiv Scientific continues to innovate, its technologies may expand treatment options and improve outcomes for patients suffering from peripheral vascular diseases worldwide.
