Arkis BioSciences wins FDA nod for CerebroFlow neuro cath

Arkis BioSciences said yesterday it won FDA clearance for its CerebroFlow external ventricular drainage catheter. The CerebroFlo catheter is designed for insertion into a ventricular cavity of the brain for external drainage of cerebro spinal fluid, and features the comapny’s Endexo technology designed to reduce obstructions, infections and lower treatment costs, Arkis BioSciences said. “Arkis’ CerebroFlo catheter is the 1st 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. The catheter’s Endexo formulation has properties that may lead to reduced complications such as catheter occlusion and infection. The clearance of CerebroFlo marks an expansion of Arkis’ surgical line, extending our reach into neurocritical care. Arkis’ new CerebroFlo catheter is poised to disrupt the neuro catheter market with its Endexo technology. Arkis’ in vitro studies have shown 99% less biomatter accumulation onto CerebroFlo’s catheter surfaces, which may reduce fouling. Further in vitro studies are underway to characterize CerebroFlo’s ability to prevent infectious biofilm formations without the use of eluting antibiotic drugs,” CEO Chad Seaver said in a prepared statement. The Knoxville, Tenn.-based company said it hopes to launch the device at the upcoming Congress of Neurological Surgeons in Boston next mont...
Source: Mass Device - Category: Medical Devices Authors: Tags: Catheters Food & Drug Administration (FDA) Neurological Regulatory/Compliance Arkis BioSciences Source Type: news