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 limitations of conventional aspiration thrombectomy systems by providing physicians with real-time control over aspiration force at the catheter tip.
Mechanical thrombectomy has become a critical treatment option for patients suffering from thrombotic and embolic vascular disease, 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.
"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., 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."
Unlike conventional aspiration thrombectomy systems that rely solely on continuous vacuum generated by syringes or electromechanical pumps, the V-PULSE system enables clinicians to rapidly initiate, stop, increase, or decrease aspiration while potentially minimizing catheter clogging and reducing procedural blood loss. "Aspiration thrombectomy systems can remove substantial volumes of blood while attempting to extract thrombus," said John O'Connor, President of Ventiv Scientific. "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 through the vascular system to the site of the clot and apply aspiration to remove obstructive thrombus. Procedural success depends on multiple factors, including clot age, composition, location, catheter design, and aspiration force. V-PULSE was developed to address these challenges through a differentiated aspiration-control platform designed to improve clot extraction performance while enhancing procedural control.
The Ventiv Scientific thrombectomy portfolio currently includes the FDA-cleared Control Aspire® Mechanical Thrombectomy System, featuring over-the-wire catheters indicated for use in the peripheral vasculature, as well as rapid-exchange catheter systems cleared for use in both peripheral and coronary applications. In addition to V-PULSE, Ventiv Scientific is developing next-generation thrombectomy technologies, including a proprietary multi-strut thrombectomy basket retrieval platform currently under development. These investigational products have not been cleared by the U.S. Food and Drug Administration.
Ventiv Scientific is a privately held medical device company focused on the design, development, and commercialization of innovative technologies for vascular intervention. The company's mission is to advance patient care through differentiated solutions that improve procedural outcomes and expand treatment options for physicians treating thrombotic disease. For more information, visit www.ventivscientific.com.
