Nashville, Tennessee - (FEB 23, 2023) – VESALIO announces the successful initial use of its NeVa VS device in the United States for the treatment of post-aneurysmal subarachnoid hemorrhage (aSAH) cerebral vasospasm. Vasospasm is the most common complication of aSAH and is the main cause of delayed morbidity and mortality. NeVa VS is the only FDA-approved device for this indication and the only device on the market specifically designed to treat life-threatening vasospasm.
Vasospasm occurs in up to 70% of patients who have experienced aSAH, a type of bleeding in the brain. The severe narrowing of brain vessels associated with vasospasm leads to reduced blood flow to the brain, which can cause ischemic injury and potentially life-threatening complications.
"We are thrilled to have achieved this U.S. market milestone and are grateful to our clinical partners for their support and dedication to this underserved patient population," said Steve Rybka, CEO of VESALIO. "The uniquely designed NeVa VS device offers an innovative solution for the treatment of post-aSAH vasospasm and has the potential to improve the quality of life for many patients."
Now available for use in the U.S., the NeVa VS device is specifically tailored to post-aSAH vasospasm treatment with its smooth and continuous architecture, operator-friendly deliverability of a stent retriever and an enhanced outward radial force to dilate critically narrowed vessels. The device provides rapid and durable vasospasm resolution and has been determined safe by the recently published VITAL trial1, which reported 93.2% of treated vessels required no retreatment.
"We are excited to be the first center to use the NeVa VS device in the U.S.," said Dr. Rishi Gupta Co-Director of the Neurosciences Service Line and Director of Cerebrovascular Care at WellStar Health System. "We have used the device in four patients thus far and have not had to return any of them to the cath lab for further treatment. The NeVa VS device is a valuable tool for the management of post-aSAH vasospasm."
With FDA approval of the NeVa VS, Vesalio is building a U.S. sales team in conjunction with the product launch. “We are committed to improving patient outcomes and expanding access to our technology,” said Bob Bushok, VP of U.S. Sales. “It is exciting to work with our clinical partners in bringing the NeVa VS device to more patients needing this critical treatment.”
Founded in 2017, Vesalio is a privately held medical device company focused on advancing patient care in vascular occlusion by providing physicians with superior technology designed to improve clinical outcomes. Vesalio’s proprietary NeVa™ and enVast™ platforms are designed to consistently achieve first-pass recanalization in stroke LV-MKT-012 Rev A and STEMI, respectively, by effectively removing all types of neurovascular clots from a patient’s anatomy. For more information, visit www.vesalio.com .
1. Gupta R, Woodward K, Fiorella D for the VITAL Study Investigators, et al. Primary results of the Vesalio NeVa VS for the Treatment of Symptomatic Cerebral Vasospasm following Aneurysm Subarachnoid Hemorrhage (VITAL) Study. Journal of NeuroInterventional Surgery 2022;14:815-819