EndoStream Medical has announced that the first patient has been enrolled in the TORNADO-US clinical study in the USA, which will evaluate the Nautilus intrasaccular system in the treatment of cerebral aneurysms.
The patient was treated at Mount Sinai Hospital in New York, USA by Icahn Mount Sinai surgeon Tomoyoshi Shigematsu.
“I was impressed by the ease of use and the versatility of the device,” Shigematsu said. “The procedure went smoothly and the patient is recovering well.”
“The enrolment of the first patient in the TORNADO-US clinical study is a major milestone for the treatment of cerebral aneurysms,” said Chris Kellner (Mount Sinai, New York, USA), principal investigator of the TORNADO-US clinical study. “We are excited to be at the forefront of this innovation.”
The Nautilus intrasaccular system is a self-conforming, intrasaccular flow diverter, designed to maximise neck coverage and enhance coil stability, optimising intrasaccular thrombosis and enabling progressive occlusion of the aneurysm. The device is CE-marked and cleared for sale in Europe, but is yet to be approved for sale or distribution in the USA, and is limited by US law to investigational use.
The first TORNADO-US patient was also treated with Kaneka i-ED coils, which were used in conjunction with the Nautilus device. As per a Nautilus press release, Kaneka i-ED coils are a new generation of coils designed for the treatment of cerebral aneurysms that have been shown to provide “excellent” aneurysm occlusion rates.
Although Shigematsu and Kellner have no financial interests with EndoStream, other faculty members in the Department of Neurosurgery at Mount Sinai are investors in this private company, the release further notes.