The FDA has cleared Arkis BioSciences’ external ventricular drainage catheter, which relieves high brain pressure and other conditions by draining cerebrospinal fluid.
The CerebroFlo catheter is inserted into the ventricular cavity of the brain for the external drainage of fluid in patients with high brain pressure, intraventricular hemorrhage—bleeding into the brain’s ventricular cavity—and hydrocephalic shunt infections.
The company will debut the device at the Congress of Neurological Surgeons in October, with plans to launch it internationally in 2018, according to a statement.
"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," CEO Chad Seaver said in a statement. "The catheter's Endexo formulation has properties that may lead to reduced complications such as catheter occlusion and infection."
Knoxville, Tennessee-based Arkis emerged from stealth last year, raising $3.4 million in its series A round in June. The company focuses on surgical instrumentation and catheter technology to make implantable drug delivery, as well as ventricular drainage procedures, less invasive and more durable.