Bluegrass Vascular Technologies received a de novo classification from the FDA for its Surfacer Inside-Out catheter access system.
The device assists with catheter insertion into the central venous system in patients with upper body venous occlusions or other conditions that make access difficult. The device is the first cleared by the FDA for patients with such conditions.
The Surfacer was approved based on positive results in a trial of thirty patients. No device related adverse events were reported, the company said.