Vesalio announces the completion of enrollment in its FDA IDE clinical study for acute ischemic stroke
Nashville, TN (May 11, 2022) – Vesalio is excited to announce the completion of patient enrollment for the CLEAR1 FDA IDE study utilizing the NeVa™ thrombectomy platform. This is an important milestone for Vesalio to complete for entering the U.S. neurovascular market to treat patients suffering from acute ischemic stroke (AIS).
AIS occurs when a blood clot blocks an artery in the brain, causing an area of the brain to die. In the U.S. alone, almost 800,000 people suffer each year from this type of stroke. Globally, AIS is one of the leading causes of long-term disability and death. Today, endovascular thrombectomy devices are the gold standard for treating AIS.
The NeVa thrombectomy platform utilizes Vesalio’s proprietary Drop Zone™ technology designed to remove different clot types including large and hard thrombus, providing a much-needed solution for physicians treating patients suffering from this debilitating, life-threatening condition. NeVa has been used for AIS in over 4,500 procedures in Europe and other global markets.
“During a thrombectomy procedure for acute ischemic stroke, the treating physician cannot ascertain the type of clot they will encounter. A thrombectomy device that can manage all clot types would contribute substantially to a doctor’s treatment arsenal,” stated Steve Rybka, CEO of Vesalio. “Completion of this IDE study is a significant milestone in our mission to improve outcomes in this patient population. We look forward to working with the FDA in the next steps of the regulatory process.”
(1) The CLEAR clinical study is a prospective, open-label, multi-center, single-arm trial designed to assess the safety, performance, and efficacy of the NeVa™ stent retriever in the treatment of Acute Ischemic Stroke (AIS).
Founded in 2013, Vesalio is a privately held medical device company focused on advancing patient care in vascular occlusion by providing physicians superior technology designed to improve clinical outcomes. The Company’s proprietary NeVa™ platform was designed to consistently achieve first-pass recanalization in acute ischemic stroke by effectively removing all types of neurovascular clots from a patient’s anatomy. For more information, visit vesalio.com.
NeVa trademark and patents are the property of Vesalio.