FDA OKs 2 New Scientia Vascular Microfabricated Catheters

Neurovascular company Scientia Vascular has earned U.S. Food and Drug Administration (FDA) clearance for two new catheters: Plato 17—a DMSO-compatible microcatheter—and Socrates 38, an aspiration catheter engineered for ischemic stroke.
 
Socrates 38 is now in the midst of a limited market release, and is gathering feedback and clinical insights. The company said this phase is crucial for the strategic launch’s final stages and bringing more advanced options for physicians treating strokes.
 
Plato 17, according to Scientia, offers control and stability for a number of neurovascular applications. The new catheter marks the company’s ability to transfer groundbreaking technology from one product line to another.
 
Scientia has expertise in microfabricated guidewires. The company applied the same technologies, design principles, and precision machinery to transform catheter manufacturing.
 
“Our FDA clearance is a significant milestone for Scientia Vascular. By applying proven microfabrication technology to catheters and designing our access and treatment devices for efficiency when used together, we’re providing physicians the next generation of neurovascular access tools,” said John Lippert, CEO of Scientia Vascular. “I am immensely grateful to our dedicated teams whose tireless efforts have made this FDA clearance milestone possible. Their commitment to excellence and innovation continues to drive our patient mission forward.”
 
“We’ve seen what microfabrication can do in products like our Aristotle 24 and Colossus wires in changing the standard of care for patient treatment in stroke, so it’s rewarding to see the excitement and buzz surrounding microfabricated technology in catheters with our physician community,” added Paul Fischer, Scientia Vascular’s chief commercial officer. “We are eager to see how these advanced technologies will enhance patient care and offer new possibilities for physicians treating a variety of neurovascular disease states.”