- Now available in limited markets across the U.S.
- FDA cleared minimally invasive tool designed for enhanced navigated accuracy in endoscopic sinus procedures
- First patients successfully treated at The Mount Sinai Hospital and Mount Sinai-Union Square in New York
IRVINE, CA – February 22, 2023 – Acclarent, Inc., part of Johnson & Johnson MedTechi, and a leader in developing minimally-invasive Ear, Nose & Throat (ENT) technologies, announced that the first ENT patients received treatment with the TruDi® Shaver Blade – a novel single-use electromagnetically navigated blade designed to enable physicians to deliver more consistent and accurate sinus procedures. The tool is now available in limited markets across the United States. The first patients were successfully treated by doctors at Mount Sinai Hospital in New York City.
Physician Comments on their experience with the innovative TruDi® Shaver Blade:
Satish Govindaraj, M.D., Associate Professor, chief of the Division of Rhinology, and Vice Chair of Clinical Affairs, Department of Otolaryngology, Mount Sinai:ii
“We are excited to help pioneer the future of ENT with the first patients treated at Mount Sinai using the latest innovation for sinus surgery procedures. The straight and angled debrider blades were accurate and efficient. With features like real-time visualization of the blade location, FAM mapping of the powered instruments, and the anatomy segmentation with alerts, we are able to perform an efficient surgery.”
Anthony DelSignore, M.D., Assistant Professor, Department of Otolaryngology and Directory of Rhinology and Endoscopy Skull Base Surgery, Mount Sinai Beth Israel:iii
“Two weeks ago, we treated a young patient with extensive nasal polyps and a history of multiple sinus surgeries in the past. Her anatomy was quite distorted, so using the TruDi® Shaver Blade, which includes a novel shaver blade that interfaces with a sophisticated navigation system, was very helpful. The procedure was a success; we were able to remove the nasal polyps and work around altered anatomy in an efficient manner with no harm to the patient. She was recently seen in the office for her post-operative visit and is doing well. I am pleased to be among the ENT physicians at the forefront of innovation in this space, as we work to deliver optimal outcomes for our ENT patients.”
The TruDi® Shaver Blade received FDA clearance 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.1 The TruDi® Shaver Blade offers surgeons a variety of sizes and angles to address different patient anatomies and is intended to be used with the Bien Air (BA) S120 Shaving Handpiece, the TruDi® Navigation System and the Bien Air OSSEODUO console.1,2
“At Acclarent, we are championing transformational innovation to drive better outcomes for people struggling with ENT conditions," said Jeff Hopkins, Worldwide President, Acclarent, Inc. “We are excited for the first uses of the TruDi® Shaver Blade because we believe it can bring significant value to physicians and patients by enabling more consistent and accurate endoscopic sinus procedures, thus driving better results for patients.”
The TruDi® Shaver Blade interacts with 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. Surgeons are also able to track the shaver movement in real-time with fast anatomical mapping (FAM), so they can see the completeness of their work.1 The distal tip sensor enables visualization of blade’s position and opening on the TruDi® Navigation System – which allows surgeons to see the cutting window on the CT so they can see exactly where they are shaving.1
Ear and sinus infections are some of the top reasons for doctor visits in the US.3 Minimally invasive procedures can be very successful in resolving ENT problems, yet too few patients receive the treatment they need. While more than 30 million Americans are diagnosed with chronic sinusitis, only approximately 800,000 receive surgical treatment.4 To find an ENT near you to discuss your symptoms and treatment options visit jnjmedtech.com/en-US/locator.
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 acclarent.com.
About Johnson & Johnson MedTechi
At Johnson & Johnson MedTech,i 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.1,2 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 sec.gov, 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.
© Acclarent, Inc. 2023
- Johnson & Johnson MedTech comprises the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
- Satish Govindaraj, M.D. does not have a consulting relationship with Acclarent, Inc. and has not been paid for any media work.
- Anthony DelSignore, M.D. does not have a consulting relationship with Acclarent, Inc. and has not been paid for any media work.
- TruDi® Shaver Blade Traditional 510(k) K221037.
- IOM005069 Rev. 2. NAV Shaver Design Input/Output Trace Matrix (IOM) dated 1/25/2021.
- Centers for Disease Control and Prevention. Chronic Sinusitis.
- Medscape. Balloon Sinuplasty.