Rebound Therapeutics has secured FDA 510(k) clearance for its Aurora Surgiscope system, which it touts as the first single-use disposable neurosurgical endoscope.
The Aurora system enables minimally invasive access, visualization and illumination during neurosurgical procedures, the Irvine, Calif.–based company said yesterday.
“Our physician advisors specified that we enable the complete neurosurgical procedure, without reliance on any third-party component, to keep the procedure minimally invasive, simple and without expensive capital equipment,” Rebound CEO Jeffrey Valko said in a news release.
“A significant opportunity exists to decrease operating room setup time, eliminate risk of infections from re-sterilizing reusable devices, and to reduce procedural cleanup and operating room turnaround time,” Valko said. “We’ve integrated state-of-the-art visualization and illumination technology into an easy to use device, compatible with current operating room high definition flat panel displays.”
The Aurora Surgiscope system includes two components: There’s a sterile, single-use, neurological endoscope called the Aurora Surgiscope and a non-sterile, reusable Image Control Box unit.