Hubly Surgical has announced the results from the first peer-reviewed study comparing the safety and efficacy of its recently US Food and Drug Administration (FDA)-cleared portable cranial access drill with smart auto-stop to a well-established, non-portable neurosurgical perforator.
The paper is published in Operative Neurosurgery and was authored by neurosurgeons at the University of Miami (Miami, USA). In the study, the Hubly drill smart auto-stop engaged properly in 100% of 174 craniotomies, the company claims.
Additionally, all perforations were complete and performed within 30 seconds or less—an improvement over the established perforator, which did not complete 5.5% of perforations. The authors conclude that the Hubly drill is both effective and safe for helping to prevent accidental plunge, which can lead to serious neurological complications or death.
“It has been our vision from the very beginning to modernise the neuro ICU [intensive care unit],” said Hubly CEO and founder Casey Qadir. “We aim to eliminate catastrophic plunge by equipping ICU cranial drills with advanced features for safety and efficiency normally only seen in operating room drills. The results from this peer-reviewed study stating Hubly drill performs equally to and, in some ways, better than a well-established cranial perforator used only in the operating room goes a long way toward making that vision a reality.”
The Hubly drill’s advanced safety features highlighted by the authors include its smart auto-stop; proprietary tapered drill bit that provides secondary mechanical plunge prevention; and LED force indicator that changes colour with force, enhancing user control.
“There are certain errors in healthcare called ‘never events’,” Qadir added. “These are defined as medical errors that are clearly identifiable and preventable. Accidental plunge with antiquated technology falls into this category. We believe our advanced technology will not only help eliminate these errors, but restore confidence in bedside cranial access, leading to reduced costs and improved outcomes.”
