FDA Clears Arkis BioSciences’ External Ventricular Drainage (EVD) Catheter

Arkis BioSciences, a leading innovator in minimally invasive surgical instrumentation, has obtained FDA clearance of its new external ventricular drainage catheter, CerebroFlo.
 
According to Chad Seaver, CEO of Arkis BioSciences, 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,” said Seaver. “The catheter’s Endexo formulation has properties that may lead to reduced complications such as catheter occlusion and infection.”
 
Seaver said Arkis plans to introduce the device to the U.S. market at the upcoming annual Congress of Neurological Surgeons (booth 747), which will be held in Boston, Oct. 7-11, 2017, and plans for international distribution beginning in 2018.
 
“The clearance of CerebroFlo marks an expansion of Arkis’ surgical line, extending our reach into neurocritical care,” said Seaver. “Arkis’ new CerebroFlo catheter is poised to disrupt the neuro catheter market with its Endexo technology.”
 
Seaver explains Endexo is a catheter technology exclusively licensed to Arkis by Interface Biologics, Inc. for neurological cerebrospinal fluid applications. Clinical studies of other catheters incorporating Endexo have shown patient benefits including markedly reduced obstructions, fewer infections, and overall lower treatment costs. 
 
“Arkis’ in vitro studies have shown 99 percent less biomatter accumulation onto CerebroFlo’s catheter surfaces, which may reduce fouling,” said Seaver. “Further in vitro studies are underway to characterize CerebroFlo’s ability to prevent infectious biofilm formations without the use of eluting antibiotic drugs.”
 
“Given the early success we have seen with our new tunneling guidewire line, I’m excited to now introduce this innovative neuro catheter to current and prospective customers,” said Ryan Gray, Arkis’ director of sales. “Existing ventricular catheters are particularly problematic due to obstructions and Endexo has the potential to make a remarkable difference to patients.”