Thursday, September 30, 2021
Acclarent, Inc., part of the Johnson & Johnson Medical Devices Companies, and a leader in developing minimally-invasive Ear, Nose & Throat (ENT) technologies, today announced the U.S. launch of its first-ever AI-powered ENT technology, designed to simplify surgical planning and provide real-time feedback during ENT navigation procedures. The new software package contains TruSeg™ and TruPath™ for use with the TruDi® Navigation System and leverages a machine learning algorithm to provide reliable and efficient image guided preoperative planning and navigation for ENT procedures, like endoscopic sinus surgery.
More than 30 million adults in the U.S. are diagnosed with sinusitis each year. Those with chronic sinusitis typically suffer from a combination of nasal congestion, facial pain/pressure, decreased sense of smell, and other symptoms impacting their quality of life.1 While chronic sinusitis is typically treated first with medication, at least 20 percent of people do not respond adequately to such treatment and may require sinus surgery.2
TruDi has enabled software-guided navigation since its launch in 2018 and is designed for ENT surgeons to deliver real-time 3D guidance, anatomical mapping, and surgical insights to assist throughout ENT procedures.
TruSeg enables surgeons to apply automatic segmentation to a patient’s anatomical structures based on a preoperative CT scan. This feature allows the precise labeling of anatomical structures, such as the eyes and brain, to function as beacons to alert the surgeon when a navigated surgical device approaches the structure during ENT procedures.
TruPath calculates and presents the shortest valid path that doesn’t cross bone.
“As one of the first ENTs to use TruDi, I immediately recognized the opportunity for this technology to help surgeons avoid unintended consequences and expand access to safe, minimally invasive, long-term solutions to patients in need of sinus surgery, said Charles Ebert, MD, MPH, Otolaryngologist and Professor, University of North Carolina Chapel Hill.** “Through this innovation we are maximizing patient care.”
Acclarent will share details and real-world experiences of ENTs utilizing TruDi at two upcoming annual meetings taking place in Los Angeles – the American Rhinologic Society (ARS) Annual Meeting (October 1-2) and the American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) Annual Meeting (October 3-6).
“The launch of this AI-powered software for TruDi is a leap forward in the evolution of image-guided ENT and skull base procedures,” said Jeff Hopkins, Worldwide President, Acclarent, Inc. “Acclarent continues to reimagine what’s possible with ENT navigation and TruDi continues to benefit patients and the ENT community through consistent accuracy, a simple workflow, and pioneering software functionality.”
For more information on TruDi and its software features, please visit: https://www.jnjmedicaldevices.com/en-US/product-family/navigation.
About Acclarent
Acclarent, part of the Johnson & Johnson Medical Devices Companies, is located in Irvine, California. 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 Medical Devices Companies
At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere.
Important Safety Information
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 Navigation System. 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, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; 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 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent 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. Neither Acclarent, the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.
**Dr. Ebert is a paid consultant to Acclarent, Inc.
Rosenfeld, R.M., Piccirillo, J.F., Chandrasekhar, S.S., et al. Clinical Practice Guideline (Update): Adult Sinusitis. Otolaryngol. Head Neck Surg. 2015;152(2S):S1–S39.
Lal, Devyani, et al. “Efficacy of Targeted Medical Therapy in Chronic Rhinosinusitis, and Predictors of Failure.” American Journal of Rhinology & Allergy, vol. 23, no. 4, Jan. 2009, pp. 396–400.
ACCLARENT® ENT Navigation System Instructions for Use. UG‐2000‐00 02A 11.2018.
