IRVINE, CA – Sept. 8, 2022 – Acclarent, Inc., part of Johnson & Johnson MedTech,* and a leader in developing minimally invasive Ear, Nose & Throat (ENT) technologies, will showcase its latest products and clinical research at the 68th Annual Meeting of the American Rhinologic Society (ARS) (September 9-10) and the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNSF) 2022 Annual Meeting & OTO Experience (September 10-14), both held in Philadelphia.
At ARS, Acclarent will highlight a poster that will outline positive results from a recent study exploring the potential impact of the TruDi® Navigation System with virtual reality in confirming successful balloon sinus dilation of the maxillary sinus. Additionally, Acclarent will host a lunch symposium with Drs. Raj Sindwani, Nithin Adappa, Zachary Cappello and Pat Colley who will discuss the applications and benefits of TruDi® Navigation across sites of service. The discussion will take place on Friday, September 9th from 12:00-12:50pm ET at the Marriott Philadelphia Downtown, Salon K 5th Floor. At AAO, Acclarent will host a symposium with Drs. Ray Weiss, Jim Atkins, Karen Hoffmann, Richard Thrasher and Ryan Vaughn to discuss the TruDi® Navigation System and how its advanced features can support ENT practices. The session will take place on Sunday, September 11th from 2:15-3:15pm ET in the OTO Experience in the Exhibit Hall.
As a company committed to advancing diversity, equity and inclusion in ENT, Acclarent will sponsor three events focused on women in rhinology and otolaryngology that aim to underscore the importance of increasing representation to create more equitable experiences for ENT patients:
- The Women in Rhinology, Diversity & Inclusion, Mentorship, Residents & Fellow Luncheon: Saturday, September 9, 12:00-1:00pm ET, Salon E (ARS)
- WIO Assembly Session: Sunday, September 11, 12:00-2:00pm ET, Exhibit Hall, OTO Experience OTOtorium
- Empowering Women Physicians to Develop Optimal Practice Health with Dr. Karen Hoffmann: Monday, September 12, 6:30-10:00pm ET, The Capital Grill (AAO)
“At this year’s meetings, we are looking forward to connecting with the ENT community to showcase our latest innovation and demonstrate our progress toward advancing ENT solutions that enable better patient outcomes,” said Jeff Hopkins, Worldwide President, Acclarent, Inc. “We’re proud that Acclarent was the first company to introduce balloon sinuplasty and eustachian tube balloon dilation, launch of the first ever AI-powered navigation technology for ENT surgeons, and the recent FDA clearance of our TruDi® Shaver Blade. We are committed to harnessing the latest science and technology to deliver transformational solutions and change the trajectory of ENT treatment.”
The TruDi® Shaver Blade Set to Enhance Accuracy in ENT Procedures
Acclarent recently announced FDA 510(k) clearance for the TruDi® Shaver Blade, a single-use electromagnetically navigated instrument, designed for surgeons to accurately target incisions and remove soft and hard tissue or bone during ENT procedures. This is the first navigable blade with distal tip sensor integration, enabling the display of the blade’s position and opening on the TruDi® Navigation System.1,2
TruDi® Navigation System uses AI-powered ENT technology 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. TruDi® Shaver Blade will be available for demonstrations onsite at both ARS and AAO at the Acclarent booth.
Nature and International Forum of Allergy & Rhinology publish new data on Acclarent technology
During the ARS Acclarent symposium on TruDi® Navigation, physicians will also discuss published data that highlights the company’s commitment to advancing innovation in the ENT space and improving patient outcomes. Recently, the International Forum of Allergy & Rhinology published a paper that examines how fast anatomical ENT mapping technology can simplify workflow, enhance treatment time and positively impact patient care.3 The study looked at the TruDi® Navigation System and determined that this tool can be utilized to enhance otolaryngology resident training in endoscopic sinus surgery at both the junior and senior levels.1
Another study, published late last year in Nature, evaluated the effects of balloon sinuplasty on the size of ostium in the maxillary sinuses and quality of life, for patients with chronic sinus conditions using the RELIEVA SPINPLUS® Balloon Sinuplasty System.4 Results showed that for the first time, balloon sinuplasty intervention increased the size of the maxillary ostium and maintained an increased size for 12 months post operation.2
For more information on the latest Acclarent products and features, please visit: www.jnjmedtech.com.
Acclarent, part of the Johnson & Johnson MedTech, 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 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
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.
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.
The RELIEVA SPINPLUS® Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.
For children aged 17 and under, the RELIEVA SPINPLUS® Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.
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, TruDi® Shaver Blade and RELIEVA SPINPLUS® Balloon Sinuplasty 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, 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.
- Douglas, J.E., Patel, T.D., Rullan-Oliver, B.E., Kohanski, M.A., Palmer, J.N. and Adappa, N.D. (2022), Novel intraoperative fast anatomic mapping as teaching adjunct in endoscopic sinus surgery. Int Forum Allergy Rhinol. https://doi.org/10.1002/alr.23046
- Kalliomäki, E., Bizaki-Vallaskangas, A.J., Valtonen, O. et al. (2021), The enlargement of the maxillary ostium after balloon sinuplasty evaluated by a novel measuring technique from 3D CBCT images. Sci Rep. https://doi.org/10.1038/s41598-021-03048-7