EndoStream enrols first patient in trial of Nautilus Intrasaccular System

EndoStream enrols first patient in trial of Nautilus Intrasaccular System

Time Stamp: February 14, 2023 9:21 AM
Source Node: 1957819

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Elastica van Gieson stain of a cerebral aneurysm with the vascular architecture highlighted. Credit: Jensflorian / commons.wikimedia.org.

EndoStream Medical has announced the enrolment of the first patient in a clinical trial of its Nautilus Intrasaccular System in the US.

The TORNADO-US clinical study trial has been designed to assess the Nautilus Intrasaccular System, a revolutionary technology for the treatment of cerebral aneurysms.

The patient received treatment at The Mount Sinai Hospital in New York.

Mount Sinai Icahn School of Medicine assistant professor of Neurosurgery Chris Kellner said: “The enrolment of the first patient in the TORNADO-US clinical study is a major milestone for the treatment of cerebral aneurysms.”

“We are excited to be at the forefront of this innovation.”

Kellner is also serving as the principal investigator of the TORNADO-US clinical study.

The patient also received treatment with Kaneka i-ED coils, which were used along side the Nautilus Intrasaccular System.

These new-generation coils have been designed to treat cerebral aneurysms and have demonstrated excellent aneurysm occlusion rates.

As a self-conforming intrasaccular flow diverter, the Nautilus System increases neck coverage and improves coil stability, which in turn optimises intrasaccular thrombosis. It also enables progressive aneurysm occlusion.

The EndoStream system promotes intrasaccular thrombosis and endothelial remodelling while eliminating the need for antiplatelet therapy.

Using any .0165in microcatheter, it can reach the smallest vessels, increasing visibility every time.

It is CE marked and has clearance for sale in Europe, however, it has not yet received approval for sale or distribution in the US.

Mount Sinai Icahn Neurosurgery, Neurology and Radiology assistant professor Tomoyoshi Shigematsu said: “I was impressed by the ease of use and the versatility of the device. The procedure went smoothly and the patient is recovering well.”

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