IRVINE, CA – August 3, 2022 – Acclarent, Inc., part of Johnson & Johnson MedTech,* and a leader in developing minimally-invasive Ear, Nose & Throat (ENT) technologies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the TruDi® Shaver Blade, a single-use electromagnetically navigated blade, used with the 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.1 The TruDi® Shaver Blade is a navigable blade with distal tip sensor integration, enabling the display of the blade’s position and opening on the TruDi® Navigation System.1
“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,” said Jeff Hopkins, Worldwide President, Acclarent, Inc. “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.”
The TruDi® Shaver Blade offers surgeons a variety of configurations with multiple angles to address different patient anatomies2 and is intended to be used with the Bien Air (BA) S120 Shaving Handpiece, the TruDi® Navigation System and the Bien Air OSSEODUO console. The TruDi® Shaver Blade interacts with all of TruDi®’s advanced navigation features including TruSeg™, which uses artificial intelligence to segment critical anatomical structures, such as the eyes and brain, which can then function as beacons to alert the surgeon when the navigated surgical 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.”
Acclarent, Inc., part of Johnson & Johnson MedTech, is located in Irvine, CA. Its singular focus is to free patients to live better lives by designing, developing and commercializing medical devices that address conditions affecting the ear, nose and throat. For more than a decade, Acclarent has led the field in delivering innovative technologies to ENT surgeons. For more information, visit www.acclarent.com.
About Johnson & Johnson MedTech*
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.
Important Safety Information
TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Acclarent Navigation Technology is intended for use by or under the direction of a physician. Devices guided by the Acclarent Navigation Technology have described risks including the potential for unintended injury to the orbits or CNS as a consequence of inaccurate navigation. Prior to use, it is important to read the Instructions for Use and to understand the registration process and the contraindications, warnings and precautions described for the system.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the TruDi® Shaver Blade. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Acclarent, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2022, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange
Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Acclarent, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
*Johnson & Johnson MedTech comprises the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
- TruDi® Shaver Blade Traditional 510(k) K221037.
- IOM005069 Rev. 2. NAV Shaver Design Input/Output Trace Matrix (IOM) dated 1/25/2021.
© Acclarent, Inc. 2022