Ventiv Scientific Completes First-in-Human Cases of V-PULSE Mechanical Thrombectomy System, Aiming to Improve Clot Removal and Reduce Blood Loss

Ventiv Scientific has announced the successful completion of its first-in-human 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 limitations of conventional aspiration thrombectomy by providing physicians with real-time control over aspiration force at the catheter tip.

Mechanical thrombectomy has become a critical treatment for patients with thrombotic and embolic vascular diseases, including Deep Vein Thrombosis (DVT), Acute Limb Ischemia (ALI), Critical Limb Ischemia (CLI), Chronic Total Occlusions (CTO), and Pulmonary Embolism (PE). These procedures can restore blood flow, relieve symptoms, preserve limbs, and save lives. However, traditional aspiration systems rely on continuous vacuum generated by syringes or electromechanical pumps, which can lead to significant blood loss and catheter clogging.

The V-PULSE system is engineered to allow clinicians to rapidly initiate, stop, increase, or decrease aspiration, potentially minimizing clogging and reducing procedural blood loss while remaining compatible with existing aspiration pumps. “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, highlighted the system's potential to reduce blood loss: “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.”

During a thrombectomy procedure, physicians advance a catheter to the clot site and apply aspiration to remove the obstructive thrombus. Success depends on factors such as clot age, composition, location, catheter design, and aspiration force. V-PULSE was developed to address these challenges through a differentiated aspiration-control platform.

Ventiv Scientific's thrombectomy portfolio currently includes the FDA-cleared Control Aspire® Mechanical Thrombectomy System, featuring over-the-wire catheters for peripheral use and rapid-exchange catheters 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 FDA.

The successful FIH cases mark a significant step toward improving outcomes for patients with thrombotic disease. For more information, visit Ventiv Scientific.