Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Balloon dilation catheters should be used by or under supervision of physicians thoroughly trained in balloon dilation. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. This information is intended for use by customers, patients, and healthcare professionals in the United States only. The information contained in this document is provided for information purposes only and represents no statement, promise or guarantee by Acclarent, Inc. concerning levels of reimbursement, payment or charge. 2020 FAQ Acclarent Coding and Reimbursement for Physician and Facilities. Use of a Sinus Balloon Catheter that is too large for the target sinus may cause damage to the Sinus Balloon and / or surrounding anatomy. Do not inflate with air or radiopaque contrast. The ACCLARENT AERA™ Eustachian Tube Balloon Dilation System is the first device in the US indicated to dilate the Eustachian tube. 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. The resources below contain valuable information on ENT coding, reimbursement and procedure documentation, Coding, Reimbursement and Documentation Resources, 2020 Acclarent Reimbursement Guide for Physician and Facilities. Prior to use, it is important to read The RELIEVA TRACT™ Nasal Balloon Dilation System is intended for use in ages 17 years or older. Prior to irrigation through the RELIEVA SPINPLUS. We use cookies on this site to enhance your user experience. The Sinus Navigation Guidewire is a precision instrument and must be handled with care. A thorough understanding of the technical principles, clinical application, and risk associated with balloon dilation of the nasal passage is necessary before using this device. Last Updated on 06/30/2020, All contents © Medical Device Business Services, Inc. 2020. ACCLARENT AERA ® Eustachian Tube Balloon Dilation System is intended for use by physicians who are trained on Acclarent Technology. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended for use by physicians who are trained on Acclarent Technology. The safety of Ethylene Oxide residuals has been established in patients weighing 10 kg and above. This site uses cookies as described in our, Updates to Medicare payment rates for 2020, Special rules for multiple endoscopic procedures, Coding and documentation updates, including use of an unlisted code. Do not pinch or kink the body of the Sinus Navigation Guidewire. This guide has been developed to assist you in obtaining appropriate physician payment and hospital facility reimbursement for Nasal/Sinus Endoscopic Surgery, Eustachian Tube Balloon Dilation, Airway Dilation, and Computer Assisted Navigation procedures. We strongly suggest that you consult your payer organization with regard to local reimbursement policies. Disclaimer: The information is provided to assist you in understanding the reimbursement process. The ACCLARENT AERA™ system uses a small balloon to treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure, pain … Ensure that the suction level is reduced to the lowest level required to remove non-viscous fluids from the field. The Balloon Sinuplasty System has a suction function that is designed to remove non-viscous fluids from the surgical field such as blood. Get the answers to commonly asked reimbursement and coding questions. Similarly, all CPT® & HCPCS codes are supplied for information purposes only and represent no statement; promise or guarantee by Acclarent, Inc. that these codes will be appropriate or that reimbursement will be made. Acclarent Navigation Technology is intended for use by or under the direction of a physician. Do not attempt to alter the distal tip shape of the Sinus Navigation Guidewire, as this may result in device damage. The Acclarent AERA Eustachian Tube Balloon Dilation System is the first device in the U.S. for dilating the Eustachian tube to treat persistent ETD. It is not intended to increase or maximize reimbursement by any payer. Do not try to move the Sinus Guide Catheter Tip or Sinus Balloon Catheter while the Sinus Balloon is inflated, as this could cause tissue trauma or device damage. Before opening the sterile package, visually inspect the package to ensure that the seals remain intact, the sterile integrity has not been compromised, and no damage has occurred during shipping and handling. The ACCLARENT AERA ® Eustachian Tube Balloon Dilation System, first-of-its-kind, is a safe and minimally invasive treatment for ETD. [email protected] 877.340.6466. You are about to leave jnjmedicaldevices.com. Advancing or retracting the Sinus Balloon Catheter while the Sinus Balloon is inflated may cause damage to the RELIEVA SPINPLUS. Use of an undersized Sinus Balloon may result in failure to properly treat the target sinus. The product information included here may not be appropriate for use outside the United States, and the information from other sites you visit may not be appropriate for use in the United States. This guide has been developed to assist in locating the appropriate HCPCS codes for Acclarent products used in the hospital outpatient setting. Physicians will continue to report the unlisted CPT® code for procedures of the middle ear. Ensure the Sinus Balloon has fully exited the guide tip before inflating. All Rights Reserved. ACCLARENT AERA ® Eustachian Tube Balloon Dilation System is intended for use by physicians who are trained on Acclarent Technology. Excessively high suction levels may cause mucosal trauma. 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 systems. DO NOT REUSE. No applicable peer-reviewed references for this page. Due to the variability of sinus development in pediatric patients and as is standard practice for endoscopic sinus surgery, appropriate radiographic imaging (e.g. By clicking to continue, you will be taken to a web site governed by their own Legal and Privacy Policies. The RELIEVA TRACT™ Nasal Balloon Dilation System is an instrument intended to provide increased intranasal space to facilitate access for endonasal and trans-nasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. Use the table of contents to easily find relevant topics, including prior approval, place of service, coding, modifiers and more. CPT® codes and descriptors copyright ©2019 American Medical Association. Do not exceed the recommended maximum Sinus Balloon inflation pressure of 12 atmospheres. ACCLARENT® Balloon Sinuplasty Devices are intended for use by or under the direction of a physician who is trained in the use of Acclarent Technology. Intended for single patient use only. Use only sterile saline or sterile water for inflation. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. We recognize that the Internet is a global communications medium; however, laws, regulatory requirements, and product information for medical products can vary from country to country. ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended for use by physicians who are trained on Acclarent technology. Do not insert or inflate the Sinus Balloon with the protective red-tipped Balloon Sheath in place. If concomitant procedures are performed during the same … As with any sinus surgery, the Balloon Sinuplasty System should only be used for treatment of pediatric patients who are not responsive to medical therapy. This site is published by Acclarent, Inc. which is solely responsible for its contents. It is intended to assist providers in accurately obtaining reimbursement for health care services. 142924-200609. We understand the importance of tools and education in helping you navigate through the complex ENT reimbursement environment. Caution: Federal (US) law restricts the sale, distribution or use of these devices to, by or on the order of a physician. Use care when connecting the Sinus Navigation Guidewire to the ACCLARENT. © Acclarent, Inc. 2020. The C- Code, C9745 may be used by hospitals and ASCs. CT scan) should be reviewed prior to surgery to assess the development of sinus anatomy and compatibility with the Sinus Balloon Catheter. EXPERIENCE RELIEF with a minimally invasive procedure. ACCLARENT AERA ® Eustachian Tube Balloon Dilation System is intended for use by physicians who are trained on Acclarent Technology. EUSTACHIAN TUBE BALLOON DILATION Effective July 1, 2017 a HCPCS code has been established to describe a Eustachian Tube Balloon Dilation (ETBD) procedure with the ACCLARENT AERA® device. This content is intended for audience within the US only. Only move or withdraw the Sinus Balloon Catheter when the Sinus Balloon is completely deflated. This update reflects the CY 2020 Medicare national average fee schedules for Physician, Hospital Outpatient and Ambulatory Surgery Centers, for Balloon Sinuplasty (BSP), Eustachian Tube Balloon Dilation (ETBD), Airway Dilation, and Navigation procedures. All rights reserved. Third party trademarks used herein are trademarks of their respective owners. ACCLARENT® Balloon Sinuplasty Device use has described risks, including tissue and mucosal trauma, infection, or possible orbital injury. The third-party trademarks used herein are trademarks of their respective owners. To prevent inadvertent fluid extravasation, such as into the orbit, do not irrigate in the presence of a bony dehiscence or defect in any sinus wall. With this system, Dr. Aminpour uses a catheter to insert a small balloon through the nose and into the Eustachian tube. It is the only available device in the United States specifically designed to dilate the Eustachian tubes for patients with persistent ETD. Eustachian Tube Balloon Dilation North Atlanta Ear, Nose, Throat and Allergy are one of the first ear, nose and throat groups in the Atlanta area to perform Eustachian Tube Balloon Dilation, with the newly approved Aera system by Acclarent. It is intended for visitors from the United States. FOR ADDITIONAL QUESTIONS OR INFORMATION CONTACT: CPT® is a registered trademark of the American Medical Association. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury.
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