Acclarent, Inc. Launches Novel 3D Navigation System Designed to Transform ENT Procedures

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First cases completed with TruDi Navigation System  that allows ENT real-time navigation in the O.R. and surgeon office

IRVINE, Calif. – APRIL 20 –  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. commercial launch of TruDi, a real-time, three-dimensional (3D) navigation system for ENT procedures performed in the operating room and surgeon office. The TruDi Navigation System recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA), and first cases were completed Monday, April 16th at two leading U.S. healthcare facilities.

TruDi is an electromagnetic image-guided navigation system designed to offer ENT surgeons an accurate, simple and reliable option for their endoscopic sinus surgery procedures. It is intended for use during intranasal and paranasal image-guided navigation procedures for eligible patients requiring sinus surgery. TruDi enables the use of RELIEVA SPINPLUS® NAV, the first 3D navigation-enabled Balloon Sinuplasty System for the treatment of chronic sinusitis.

“TruDi enables precise localization of the surgical device relative to the preoperative CT scan, facilitating the surgeon’s understanding of the complex anatomy of the narrow spaces of the paranasal sinuses,” said Dr. Martin J. Citardi**, Professor and Chair of the Department Otorhinolaryngology-Head and Neck Surgery at McGovern Medical School at The University of Texas Health Science Center at Houston. “The system incorporates microsensor technology, innovative tracking hardware and software tools enabling the surgeon to easily and accurately confirm instrument placement during minimally invasive sinus procedures.”

Acclarent developed TruDi in collaboration with Biosense Webster, Inc., the global leader in the science of diagnosing and treating heart rhythm disorders. TruDi leverages Biosense Webster’s advanced imaging system which utilizes electromagnetic technologies to help electrophysiologists navigate the beating heart by generating an accurate map, and pinpoints the exact location and orientation of catheters used during diagnostic and therapeutic procedures.

“With the launch of TruDi, Acclarent builds on its legacy of pioneering minimally invasive treatment options for patients suffering from Chronic Sinusitis and Eustachian Tube Dysfunction,” said Shlomi Nachman, Company Group Chair of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions. “We’re extremely proud of this advancement and the potential it has to transform ENT procedures.”

After pioneering Balloon Sinuplasty as a minimally invasive treatment option for chronic sinus sufferers, Acclarent went on to develop the first Eustachian Tube Dysfunction intervention with ACCLARENT AERA.  With TruDi, Acclarent has now taken another step in advancing ENT paranasal sinus surgery with innovative 3D navigation technology.

About the Johnson & Johnson Medical Devices Companies

The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

About Acclarent, Inc.

Acclarent, Inc., part of Johnson & Johnson Medical Devices Companies, 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

*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within the Medical Devices segment of Johnson & Johnson.

**Dr. Citardi is a paid consultant to Acclarent, Inc. Opinions expressed are his own.

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.