Scientia Vascular, an early stage medical device company with patented and proprietary vascular access technology, recently received FDA clearance for a new product called the Aristotle 14 guidewire, which is used during ischemic and hemorrhagic strokes and other challenging interventional procedures.
The company reports that the Aristotle guidewire improves access to difficult-to-reach vasculature and enables interventional physicians to have precise control to target treatment sites deep within the brain and other parts of the body. Unlike conventional designs, the Aristotle provides a unique balance of what is typically offsetting engineering properties such as flexibility and torque control and represents the next generation in access technology.
Upon receiving clearance on January 22, 2018, the company commenced a Physician Preference Evaluation (PPE) of the Aristotle at six large teaching hospitals in the U.S. to gather performance feedback. After completing the first 30 neurovascular and peripheral procedures, the overall physician impression was that the Aristotle showed significant performance improvement compared to current products, including other microfabricated nitinol guidewires. When comparing the Aristotle to their preferred guidewires, physicians rated the ability to shape the wire as 4.8 (on a scale from 1-Poor to 5-Superior), torque control and steering as 4.6, tracking as 4.2, shape retention as 4.3 and ability to reshape as 4.4. When asked how likely they would adopt the use of the Aristotle, the majority of physicians suggested that they would use the product often or even switch.
“The feedback from physicians who experienced the new Aristotle guidewire reinforces that our patented microfabricated designs offer some outstanding performance attributes, such as tip shaping and precise control, which allow physicians to better navigate complicated and distal anatomy,” said John Lippert, CEO and founder of Scientia Vascular. He went on to say, With many of the prevailing patents in microfabrication technology expired, Scientia is excited and poised to bring the next-generation access products to patients.”
Currently, microfabricated nitinol guidewires occupy the high end of the market with over 60% share of the interventional guidewire segment, often being preferred for the most challenging procedures, including areas outside of the neurovasculature.
At its facility near Salt Lake City, Utah, the company has manufacturing capability and capacity to scale appropriately to meet the anticipated demand. The Aristotle is currently available for sale with more information available at www.scientiavascular.com.