EndoStream Medical Announces First Patient Enrolled in U.S. Clinical Trial for Nautilus™ Intrasaccular System in Treatment of Cerebral Aneurysms
OR AKIVA, Israel, Feb. 13, 2023 /PRNewswire/ -- EndoStream Medical today announced the first patient enrolled in the TORNADO-US clinical study in the U.S. This study evaluates the Nautilus™ Intrasaccular System, a revolutionary technology designed to treat cerebral aneurysms. The patient was treated at The Mount Sinai Hospital in New York, one of the largest and most respected hospitals in the nation.
"The enrollment of the first patient in the TORNADO-US clinical study is a major milestone for the treatment of cerebral aneurysms," said Chris Kellner, MD, Assistant Professor of Neurosurgery at the Icahn School of Medicine at Mount Sinai and Principal Investigator of the TORNADO-US clinical study. "We are excited to be at the forefront of this innovation."
Tomoyoshi Shigematsu, MD, Assistant Professor of Neurosurgery, Neurology and Radiology at Icahn Mount Sinai and the surgeon who performed this first-in-US case, 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."
In addition to the Nautilus Intrasaccular System, the patient was treated with Kaneka i-ED coils, which were used in conjunction with the Nautilus. The Kaneka i-ED coils are a new generation of coils designed for the treatment of cerebral aneurysms and have been shown to provide excellent aneurysm occlusion rates.
Although Drs. Shigematsu and Kellner have no financial interests with EndoStream Medical, other faculty members in the Department of Neurosurgery at Mount Sinai are investors in this private company.
About the Nautilus Intrasaccular System:
The Nautilus is a self-conforming intrasaccular flow diverter, maximizing neck coverage and enhancing coil stability, to optimize intrasaccular thrombosis and enable progressive occlusion of the aneurysm.
The Nautilus is CE marked and clear for sale in Europe. The Nautilus is not approved for sale or distribution in the US and is limited by U.S. law to investigational use.
About EndoStream Medical:
EndoStream Medical is dedicated to developing innovative solutions that significantly improve clinical outcomes for patients suffering from brain aneurysms. For more information visit www.endostream.com.
Contact:
Danel Mayer, CEO
Tel: +972-4-842-4810
Email: [email protected]
SOURCE EndoStream Medical
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