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February 15, 2023
EndoStream Medical Begins Enrollment in United States TORNADO-US Trial for Nautilus Intrasaccular System
February 15, 2023—EndoStream Medical, a company developing solutions for brain aneurysms, announced that the first patient was enrolled in the TORNADO-US clinical study in the United States. The study will evaluate the company’s Nautilus intrasaccular system for treatment of cerebral aneurysms.
The Nautilus is a self-conforming intrasaccular flow diverter designed to maximize neck coverage, enhance coil stability, optimize intrasaccular thrombosis, and enable progressive occlusion of the aneurysm.
The first patient, treated at The Mount Sinai Hospital in New York, New York, also received treatment with Kaneka i-ED coils (Kaneka Neurovascular USA), which are designed for cerebral aneurysms and have been shown to provide good occlusion rates, noted the company in the press release.
Nautilus has CE Mark approval; in the United States, it is limited by United States law to investigational use and is not approved for sale or distribution in the United States.
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