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Johnson & Johnson MedTech’s Acclarent business announced FDA 510(k) clearance for its TruDi shaver blade and its advanced navigation features.

In a news release posted yesterday, Acclarent described TruDI as a single-use electromagnetically navigated blade. It’s used with the company’s Bien-Air S120 shaver for the incision and removal of soft and hard tissue or bone in ENT, maxillofacial surgery, head and neck, and ENT skull base surgery.

The TruDi shaver blade is navigable. It has distal tip sensor integration, enabling the display of the blade’s position and opening on the TruDi navigation system.

“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. professor at the Department of Otolaryngology – Head & Neck Surgery at the University of North Carolina – Chapel Hill. “

“The TruDi Shaver Blade represents a technological innovation that can enable more consistent and accurate procedures,” Ebert said in the news release. “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.”

Acclarent President Jeff Hopkins described the clearance as 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.”

The TruDi shaver blade includes a variety of configurations with multiple angles. The idea is to address different patient anatomies.

The blade is intended for use with the Bien Air (BA) S120 shaving handpiece, the TruDi navigation system and the Bien Air OsseoDuo console. The TruDi shave blade interacts with all of TruDi’s advanced navigation features.

Filed Under: 510(k), Food & Drug Administration (FDA), Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance, Surgical Tagged With: Acclarent Inc., Johnson & Johnson

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