Scientia Vascular today announced it received FDA clearance for its two catheters, Plato 17 and Socrates 38.
The Plato 17 catheter is a DMSO-compatible microcatheter, and Socrates 38 is an aspiration catheter for ischemic stroke. The company said the clearance of these devices is a step toward full market release.
“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,” Chief Commercial Officer Paul Fischer said in a news release. “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.”
Plato 17 is a microcatheter used for neurovascular care that the company designed with softness and stability that is ideal for delivering embolic coils, stents, PVA, DMSO and Onyx. It has thousands of transition zones to ensure a seamless flexibility gradient and a continuous transitioning flexibility profile to prevent prolapse out of a selected vessel.
According to the company, the Plato 17’s design is an “intricate pattern of rings and beams” on nitinol tubing. The design allows for direct push translation from end to tip, allowing physicians to achieve a near one-to-one push response.
Socrates 38 is in a limited market release. The aspiration catheter is still gathering feedback and clinical insights before the final stages of a strategic launch to bring more advanced options to physicians treating stroke.
“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 CEO John Lippert. “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.”
