Arkis BioSciences obtains FDA clearance for new catheter
Arkis BioSciences, a leading innovator in minimally invasive surgical instrumentation, has obtained U.S. Food and Drug Administration clearance of its new external ventricular drainage catheter, CerebroFloTM.
Chad Seaver, Chief Executive Officer of Arkis BioSciences said the new catheter will be used for insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid in patients with elevated intracranial pressure, intraventricular hemorrhage, or hydrocephalic shunt infections.
“Arkis’ CerebroFlo catheter is the first neuro catheter to incorporate Endexo®, a permanent polymer additive whose properties have been shown to reduce protein adhesion and activation in laboratory in vitro studies,” Seaver added. “The catheter’s Endexo formulation has properties that may lead to reduced complications such as catheter occlusion and infection.”
Arkis plans to introduce the device to the U.S. market at the annual Congress of Neurological Surgeons set for the middle of October in Boston.
“The clearance of CerebroFlo marks an expansion of Arkis’ surgical line, extending our reach into neurocritical care,” Seaver said. “Arkis’ new CerebroFlo catheter is poised to disrupt the neuro catheter market with its Endexo technology.”
Endexo is a catheter technology exclusively licensed to Arkis by Interface Biologics, Inc.® for neurological cerebrospinal fluid applications. Seaver said that clinical studies of other catheters incorporating Endexo have shown patient benefits including markedly reduced obstructions, fewer infections, and overall lower treatment costs.
Arkis recently moved into the new privately-developed building on the University of Tennessee’s Cherokee Farm Innovation Campus.