J&J’s Acclarent Earns FDA Nod for TruDi Shaver Blade

Acclarent, a part of Johnson & Johnson MedTech, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its TruDi shaver blade, a single-use electromagnetically navigated blade, used with the Bien-Air S120 shaver, for incision and removal of soft and hard tissue or bone in ENT, maxillofacial surgery, head and neck, and ENT skull base surgery.
 
The navigable blade features distal tip sensors to enable display of the blade’s position and opening on the TruDi navigation system.
 
“We are excited about the FDA clearance of the TruDi Shaver Blade because this new tool provides never-before-seen navigated accuracy and precision that gives ENT physicians the confidence they need to perform consistently successful endoscopic sinus procedures,” Jeff Hopkins, worldwide president of Acclarent told the press. “This FDA clearance marks an important milestone in Acclarent’s journey toward our mission to change the ENT landscape through innovative technology and help physicians deliver improved patient outcomes.” 
 
Multiple configurations with multiple angles help address different anatomies. The TruDi shaver blade is intended to be used with the Bien Air (BA) S120 Shaving Handpiece, the TruDi Navigation System, and the Bien Air OSSEODUO console. The blade interacts with all of TruDi’s advanced navigation features, including TruSeg that uses artificial intelligence to segment critical anatomical structures like the eyes and brain, which can then become “beacons” to alert the surgeon when the navigated device approaches the structure during ENT procedures.
 
“When performing endoscopic sinus procedures, every millimeter counts, so a navigable shaver blade connected to a sophisticated mapping system that provides real-time visualization of the blade location helps me know where I am, where my trainees are, and where we are going during surgery,” said Dr. C.S. Ebert, Jr., Director, NeuroRhinology; Professor, Department of Otolaryngology – Head & Neck Surgery, University of North Carolina – Chapel Hill. “The TruDi Shaver Blade represents a technological innovation that can enable more consistent and accurate procedures. These features along with FAM mapping of the powered instruments, the anatomy segmentation with alerts, and 3D views with a true-to-size icon changes the paradigm in powered instrument navigation.”