Medical device manufacturer VentiV Scientific has secured U.S. Food and Drug Administration (FDA) clearance for its advanced mechanical thrombectomy system, marking a significant development in treating various vascular diseases and life-threatening blood clot conditions.
The new VentiV Pulse platform represents a technological advancement in addressing critical medical challenges across multiple vascular interventions. Thrombectomy procedures are essential in treating conditions such as acute myocardial infarction, acute ischemic stroke, peripheral arterial disease, and deep vein thrombosis, among others.
Dan Ryan, a member of VentiV Scientific's Board of Directors, highlighted the system's unique capabilities. Unlike traditional electric pump-based thrombectomy systems that can unexpectedly clog or remove substantial blood volumes, the Pulse platform offers clinicians unprecedented control. The system enables immediate adjustments to thrombectomy force, reduces internal catheter clogging, and minimizes blood loss during procedures.
The FDA clearance encompasses 18 large-lumen catheter systems specifically designed to address diverse clinical needs and potentially reduce procedural costs. Current thrombectomy techniques typically involve accessing the femoral artery or vein, tracking a catheter to the blood clot location, and applying suction through various mechanical means.
Significant variables influencing thrombectomy success include blood clot characteristics such as age, size, and location, as well as catheter specifications and aspiration force. The VentiV Pulse platform aims to provide medical professionals with more precise and adaptable tools for managing these complex procedural requirements.
This technological advancement could have substantial implications for patient outcomes across multiple medical specialties. By offering more refined blood clot removal techniques, the system may help reduce patient recovery times, minimize complications, and improve overall treatment efficacy for conditions that can result in significant disability or life-threatening complications.
The FDA clearance represents a critical milestone for VentiV Scientific, positioning the company as an innovative player in medical device development. While the company's novel unibody multi-strut thrombectomy basket retriever technology remains under development, the current system provides a significant step forward in vascular intervention techniques.
