Vesalio has announced the successful initial use of its NeVa VS device in the USA for the treatment of post-aneurysmal subarachnoid haemorrhage (aSAH) cerebral vasospasm.
“We are excited to be the first centre to use the NeVa VS device in the USA,” said Rishi Gupta (WellStar Health System, Atlanta, USA). “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.”
As per a press release from the company, NeVa VS is the only US Food and Drug Administration (FDA)-approved device for this indication and the only device on the market specifically designed to treat vasospasm—a common complication of aSAH that can cause ischaemic injury and potentially life-threatening complications.
The NeVa VS device is specifically tailored to post-aSAH vasospasm treatment owing to its “smooth and continuous architecture, operator-friendly deliverability of a stent retriever, and an enhanced outward radial force to dilate critically narrowed vessels”, Vesalio’s press release notes. The device also provides “rapid and durable vasospasm resolution”, and has been determined safe by the recently published VITAL trial, which reported that 93.2% of treated vessels required no retreatment.
“We are thrilled to have achieved this US 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.”