IRVINE, Calif., September 30, 2021 / PRNewswire / – Acclarent, Inc., a subsidiary of Johnson & Johnson Medical Devices Companies,* and a leader in the development of minimally invasive ENT technologies, today announced the launch in the United States of its first-ever AI-powered ENT technology, designed to simplify surgical planning and provide timely feedback. real during ENT navigation procedures. New software package contains TruSeg â¢ and TruPath â¢ for use with TruDiÂ® Navigation system and operates a machine learning algorithm to provide reliable and efficient image-guided preoperative planning and navigation for ENT procedures, such as endoscopic sinus surgery.
In the United States, more than 30 million adults are diagnosed with sinusitis each year.1 People with chronic sinusitis typically experience a combination of nasal congestion, facial pain / pressure, decreased smell, and other symptoms that impact their quality of life.1 While chronic sinusitis is usually treated with medication first, 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 provide real-time 3D advice, anatomical mapping and surgical information to assist them throughout ENT procedures.
- TruSeg allows 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 is approaching the structure during ENT procedures.
- TruPath calculates and presents the shortest valid path that does not cross bones.
“As one of the first ENT to use TruDi, I immediately recognized the opportunity of this technology to help surgeons avoid unintended consequences and expand access to safe, minimally invasive and long-term solutions. term for patients requiring sinus surgery, “said Charles Ebert, MD, MPH, otolaryngologist and professor, University of North Carolina Chapel Hill.** âWith this innovation, we are maximizing patient care.
Acclarent will share details and real-world experiences of ENTs using TruDi at two upcoming annual meetings taking place in Los Angeles – the annual meeting of the American Rhinologic Society (ARS) (October 1 and 2) and the American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) Annual Meeting (October 3-6).
âThe launch of this AI-based software for TruDi is a quantum leap in the evolution of image-guided ENT and skull base procedures,â said Jeff Hopkins, Global President, Acclarent, Inc. âAcclarent continues to reinvent what is possible with ENT navigation and TruDi continues to benefit ENT patients and the ENT community with consistent accuracy, simple workflow and pioneering software features.3
For more information about TruDi and its software features, please visit: https://www.jnjmedicaldevices.com/en-US/product-family/navigation.
Acclarent, part of the Johnson & Johnson Medical Devices companies, is located at Irvine, California. Its singular goal is to enable patients to live better lives by designing, developing and marketing medical devices that treat conditions affecting the ear, nose and throat. For more than a decade, Acclarent has been a leader in providing innovative technologies to ENT surgeons. For more information, visit www.acclarent.com.
About Johnson & Johnson Medical Device Companies*
At Johnson & Johnson Medical Devices Companies, we help people live their best lives. With over 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, orthopedics, vision and interventional solutions, we are helping to save lives and pave the way for a healthier future for everyone, everywhere.
Important safety information
Acclarent’s navigation technology is intended for use by or under the direction of a physician. Acclarent’s navigation technology-guided devices have described risks, including the potential for unintentional injury to the eye sockets or CNS due to improper navigation. Before use, it is important to read the instructions for use and understand the registration process and the contraindications, warnings and precautions described for the system.
Cautions Regarding Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 relating to 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 the underlying assumptions prove to be inaccurate or if known or unknown risks or uncertainties materialize, actual results could differ materially from the expectations and projections of Acclarent, any other Johnson & Johnson Medical Devices and / or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of business success; patent challenges; competition, including technological advances, new products and patents obtained by competitors; manufacturing difficulties and delays; product efficacy or safety issues resulting in product recalls or regulatory action; changes in applicable laws and regulations, including global healthcare reforms; changes in the behavior and spending patterns of buyers of health care products and services; and trends in the containment of health care costs. A list and additional descriptions of these risks, uncertainties and other factors are available in Johnson & Johnson’s annual report on Form 10-K for the year ended. January 3, 2021, including in the sections entitled âCaution Regarding Forward-Looking Statementsâ and âSection 1A. Risk Factors âand in the company’s latest Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these documents are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Acclarent, nor 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.
Â© Acclarent, Inc. 2021
* Johnson & Johnson Medical Devices companies include the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.
** Dr Ebert is a paid consultant to Acclarent, Inc.
1 Rosenfeld, RM, Piccirillo, JF, Chandrasekhar, SS, et al. Clinical practice guideline (update): Sinusitis in adults. Otolaryngol. Head and neck surgery. 2015; 152 (2S): S1 â S39.
2 Lal, Devyani et al. “Effectiveness of targeted medical treatment in chronic rhinosinusitis and predictors of failure.” American Journal of Rhinology and Allergy, vol. 23, no. 4, Jan 2009, p. 396â400.
3 ACCLARENTÂ® ENT navigation system user manual. UG â 2000â00 02A 11.2018.
SOURCE Acclarent, Inc.