FDA Clears New Mechanical Thrombectomy System
Novel clot removal platform designed to improve force, increase control, and decrease blood-loss is a major expansion of VentiV Scientific’s thrombectomy solutions.
Novel clot removal platform designed to improve force, increase control, and decrease blood-loss is a major expansion of VentiV Scientific’s thrombectomy solutions.
VentiV Scientific News
SALT LAKE CITY, UT — VentiV Scientific announced the FDA clearance of VentiV Mechanical Thrombectomy system to remove blood clots from the peripheral vasculature including the new VentiV Pulse platform.
Blood clot removal (thrombectomy) is a common procedure than can reduce patient pain, suffering, disability, and save lives. Coronary thrombectomy is associated with acute myocardial infarction (AMI), neurovascular thrombectomy is associated with acute ischemic stroke, and peripheral thrombectomy is associated with peripheral arterial disease (PAD), acute limb ischemia (ALI), critical limb ischemia (CLI), chronic total occlusion (CTO), deep vein thrombosis (DVT), pulmonary embolism (PE), and other peripheral vascular disease (PVD).
“Electric pump-based thrombectomy systems can unexpectedly clog and/or remove 5 – 15ml per second of blood before removing blood clots,” said Dan Ryan, Board of Directors, VentiV Scientific Inc. “The Pulse is designed to instantly start, stop, increase, and/or decrease thrombectomy force at the tip, decrease clogging inside the catheter, and decrease blood-loss with use of any aspiration pump currently in the hospital.”
During most thrombectomy procedures, clinicians access the femoral artery or vein; track a catheter over a guidewire to the thrombi (blood clot) or emboli; and then apply suction with a syringe, aspirator, and/or electromechanical pump. Blood clot age, size, and location plus catheter size, type, shape, and aspiration force a
re important variables during thrombectomy. Electric pumps can aspirate fast, but are often associated with significant blood-loss.
“Patients, physicians, nurses, and technologists need more tools to treat diverse patient needs,” continued Mr. Ryan. “This FDA clearance includes (18) large-lumen catheter systems designed to solve unmet clinical needs and reduce procedural costs.”
The VentiV Scientific product line includes FDA cleared over-the-wire catheters indicated for use in the peripheral vasculature plus rapid-exchange catheter systems cleared for use in the peripheral and coronary vasculature. VentiV’s novel unibody multi-strut thrombectomy basket retriever technology is under development and not FDA cleared at this time.
VentiV Scientific is a private company that designs, develops, and commercializes innovative medical devices www.VentiVScientific.com.
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