Ventiv Scientific today announced the successful completion of its first-in-human clinical cases utilizing the V-PULSE Mechanical Thrombectomy System, a novel thrombectomy platform designed to remove blood clots from the peripheral vasculature. The procedures were conducted at St. Joseph Heart & Vascular Center in Orange, CA, by Dr. Makmood Razavi.
The V-PULSE system is differentiated from conventional aspiration thrombectomy systems by providing real-time control over aspiration force at the catheter tip. Unlike systems that rely solely on continuous vacuum generated by syringes or electromechanical pumps, V-PULSE enables clinicians to rapidly initiate, stop, increase, or decrease aspiration, potentially minimizing catheter clogging and reducing 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 Dr. Razavi. "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."
Mechanical thrombectomy is a critical treatment option for patients with 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). The V-PULSE platform was engineered to address challenges such as clot age, composition, and location, which affect procedural success.
"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."
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 catheter systems for peripheral and coronary applications. The company is also 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 more information, visit www.ventivscientific.com.
