Scientia Vascular has announced the US Food and Drug Administration (FDA) 510(k) clearance of the Aristotle Colossus macrowire. The company claims that this device is the only 0.035-inch macrowire currently indicated for neurovascular intracranial use.
Like its predecessors—the Aristotle 18 and Aristotle 24, which have expanded treatment options in thousands of procedures to date, according to a Scientia press release—Aristotle Colossus utilises “breakthrough microfabrication design technology”.
This advancement in manufacturing allows for a soft, atraumatic tip and is designed to support the tracking of large bore catheters to the treatment site, and drive superior navigability of distal, tortuous anatomies. The combination of these benefits for patients and clinicians will impact “a myriad of procedures” in both ischaemic and haemorrhagic stroke care, the release notes.
“We are grateful to be one of the first labs in the world to evaluate the Aristotle Colossus’ performance,” said David Fiorella (Stony Brook Cerebrovascular Center, Stony Brook, USA). “Colossus could be a real gamechanger for stroke catheter navigation. In my initial experience, the Colossus navigated challenging neurovascular anatomy with precise torque control and provided solid support, allowing us to seamlessly and safely track aspiration catheters into both proximal and distal vessels. I anticipate that Colossus will be our wire of choice for most thrombectomy procedures going forward.”
The Aristotle Colossus combines multiple benefits of existing neurovascular access tools available to clinicians, Scientia claims, stating that, despite the large diameter of the microfabricated nitinol tube, the Colossus safely navigates the anatomy—similarly to a much smaller guidewire. In addition, it offers support to facilitate the tracking of catheters with a 0.038-inch inner diameter, and greater, with the intended aim of eliminating the use of an additional intermediate catheter.
“Treatment for stroke has resulted in advancements in procedures that have greatly benefitted the patient, but have physicians truly had the tools available to match that progression?” said John Lippert, CEO of Scientia. “With the launch of our innovative Aristotle Colossus guidewire, we are thrilled to provide a wire that has been designed for the most safe and efficacious outcomes to better meet evolving physician and patient needs.”