Scientia Vascular Receives FDA Clearance for Aristotle Colossus, the Only 0.035” Macrowire Indicated for Neurovascular Intracranial Use

SALT LAKE CITY, UTAH – March 9, 2023  Scientia Vascular, a leader and pioneer in differentiated neurovascular access technology, announces FDA 510k clearance of the Aristotle Colossus macrowire. Like its predecessors the Aristotle 18 and Aristotle 24 that have expanded treatment options in thousands of procedures to date, Aristotle Colossus utilizes 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 anatomy. The combination of these benefits for patients and clinicians will impact a myriad of procedures in both ischemic and hemorrhagic stroke care. 

“Treatment for stroke has resulted in advancements in procedures that have greatly benefited the patient, but have physicians truly had the tools available to match that progression?” poses John Lippert, CEO of Scientia Vascular. “With the launch of our innovative Aristotle Colossus guidewire, we’re thrilled to provide a wire that’s been designed for the most safe and efficacious outcomes to better meet evolving physician and patient needs.”

The Aristotle Colossus combines multiple benefits of existing neurovascular access tools available to clinicians. Despite the large diameter of the microfabricated nitinol tube, the Colossus safely navigates the anatomy similar to a much smaller guidewire. In addition, the Colossus offers the support to facilitate the tracking of catheters with a 0.038” inner diameter and above, aiming to eliminate the use of an additional intermediate catheter.

“We are grateful to be one of the first labs in the world to evaluate the Aristotle Colossus’s performance,” said Dr. David Fiorella, Director of the Stony Brook Cerebrovascular Center (Stony Brook, NY). “Colossus could be a real game changer 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.”    

About Scientia
At Scientia Vascular, we believe that without access, therapy can not exist. Our mission is to combine knowledge and technology with precision and quality to bring new solutions to patients. Through cutting-edge innovation, we’re driving our mission to radically disrupt the way diseases of the brain are treated. Our teams have been at the forefront of neurovascular systems, pushing beyond established boundaries and challenging the status quo to deliver the products physicians and patients need most.