FDA clears Arkis CerebroFlo catheter with Interface’s Endexo technology
The FDA has approved Arkis BioSciences’ CerebroFlo external ventricular drain (EVD) catheter that includes Interface Biologics’ Endexo technology.
The CerebroFlo catheter has demonstrated a 99% reduction in thrombus accumulation in-vitro, and is indicated for temporary use in patients with elevated intracranial pressure, intraventricular hemorrhage, or hydrocephalic shunt infections.
Arkis licensed the Endexo technology for cerebral spinal fluid shunting, including EVD catheters in March 2015.
Interface’s Endexo technology has been proven to be highly effective for reducing catheter occlusions and thrombosis. Endexo also has significant manufacturing advantages over other anti-thrombogenic coating or impregnation alternatives and does not change the mechanical or functional properties of the underlying medical device.
In a statement, Mark Steedman, VP of business development for Interface, said Arkis’ EVD catheter represents a beachhead for Endexo technology applications in neurology and other categories.
“At Arkis, we’re all about enhancing treatment outcomes, reducing risks and lowering the overall cost of care to improve the lives of people suffering from intracranial hypertension, and licensing Endexo technology helps us to deliver on this promise,” Chad Seaver, CEO of Arkis, added.