Ventiv Scientific today announced the successful completion of its first-in-human (FIH) clinical cases utilizing the V-PULSE™ Mechanical Thrombectomy System, a novel thrombectomy platform developed to remove blood clots from the peripheral vasculature. The system is designed to address challenges in treating 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).
Unlike conventional aspiration thrombectomy systems that rely solely on continuous vacuum generated by syringes or electromechanical pumps, the V-PULSE system provides physicians with real-time control over aspiration force at the catheter tip. This capability enables clinicians to rapidly initiate, stop, increase, or decrease aspiration while potentially minimizing catheter clogging and reducing procedural blood loss. The integrated filtration technology offers immediate visual confirmation of thrombus capture, a feature highlighted by Makmood Razavi, M.D., of St. Joseph Heart & Vascular Center in Orange, CA, who stated that the device demonstrated excellent control and procedural efficiency in initial experience.
John O’Connor, President of Ventiv Scientific, emphasized that 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 existing aspiration pumps in hospitals. This innovation addresses critical factors in procedural success, including clot age, composition, location, catheter design, and aspiration force.
The Ventiv Scientific thrombectomy portfolio currently includes the FDA-cleared Control Aspire® Mechanical Thrombectomy System, featuring over-the-wire catheters indicated for peripheral vasculature and rapid-exchange catheter systems cleared for peripheral and coronary applications. In addition to V-PULSE, 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.
The successful FIH cases mark a significant step in advancing thrombectomy technology, potentially improving outcomes for patients suffering from thrombotic and embolic vascular disease. Effective clot removal is critical, as delayed treatment can lead to serious complications. By offering enhanced control and efficiency, the V-PULSE system aims to expand treatment options and improve procedural results.
