© Acclarent, Inc. 2019. The RELIEVA CIRCA® Ethmoid Punch is an instrument for the excision of bone and soft tissue in the ethmoid sinus in adults, and is intended for use by or under the direction of a physician with experience in sinus surgery. Third party trademarks used herein are trademarks of their respective owners. Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you. Caution: Federal (US) law restricts the sale, distribution or use of these devices to, by or on the order of a physician. Acclarent Technology is intended for use by or under the direction of a physician. It is intended for visitors from the United States. We use cookies on this site to enhance your user experience. %PDF-1.4
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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. You are about to leave jnjmedicaldevices.com. Am J Rhinol Allergy; 2012, 26: 1-6. endstream
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<. Nasal/sinus endoscopy, surgical with frontal sinus exploration, with or without removal of tissue from frontal sinus $2,687 $2,687 (Payment x Bilateral adjustment) 31295-50-51. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Please contact a local Acclarent representative to learn more about the dedicated in-office programs and resources. ACCLARENT AERA™ Eustachian Tube Balloon Dilation System (Currently can only be done as a outpatient procedure at Marin General) Do you have persistent ear discomfort? This site is published by Acclarent, Inc. which is solely responsible for its contents. Acclarent Technology is intended for use by or under the direction of a physician. This site uses cookies as described in our, Restore normal sinus drainage and function without bone or tissue removal, which preserves future treatment options, Consider the opportunity for earlier intervention when medical therapy has failed, Perform Balloon Sinuplasty In-Office procedures within a comfortable office setting under local anesthetic, Lower the financial burden for eligible patients (reduced copay and procedural costs). Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Caution: Federal (U.S.) law restricts the sale, distribution or use of the ACCLARENT AERA™ by or on the order of a physician who is trained in the use of Acclarent technology. Office-based sinus dilation may be a compelling option for patients who decline or are ineligible for traditional OR-based surgery. Albritton, F et al. Karanfilov B, Silvers S, Pasha R, Sikand A, Sillers M; for the ORIOS2 study investigators. Acclarent, Inc. manufactures medical devices. This site is published by Acclarent, Inc. which is solely responsible for its contents. Balloon Sinuplasty: Advanced Technology In Action, RELIEVA SPINPLUS® Balloon Sinuplasty System Brochure, RELIEVA SCOUT® Multi-Sinus Dilation System Brochure, RELIEVA CIRCA® Ethmoid Punch Product Brochure, RELIEVA SPINPLUS® Balloon Dilation System, RELIEVA SCOUT® Multi-Sinus Dilation System, 1. Use care in the selection of your doctors and hospital, based on their skill and experience. 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. %%EOF
2. Last Updated on 10/11/2019, All contents © Medical Devices Business Services, Inc. 2020. Office-Based Balloon Sinus Dilation: A Prospective, Multicenter Study of 203 Patients. •ACCLARENT AERA™ Eustachian Tube Balloon Dilation Surgical Indications5 •Persistent OME or Non-adherent atelectasis AND Type B or C tympanogram AND ET pathology on endoscopy usually inflammation •Flight or Scuba barochallenge AND ET pathology •Symptomatic- CHL, pain/blockage w pressure change •Symptoms improved with tympanostomy tube if done •Absence of autophony … Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions. ACCLARENT AERA ® Eustachian Tube Balloon Dilation System is intended for use by physicians who are trained on Acclarent Technology. Acclarent has committed teams and programs to facilitate staff preparedness and ensure procedure and office transition success. By clicking to continue, you will be taken to a web site governed by their own Legal and Privacy Policies. 2013;3(5):404-411.Epub 2012 Nov 7 Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices. 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. With Balloon Sinuplasty In-Office, the procedure is often performed under local anesthesia and the majority of patients return to normal activity within two days of the procedure.1. Caution: Federal (US) law restricts the sale, distribution or use of these devices to, by or on the order of a physician. �`"�kX�,8}�Q[��ċ��0.k[���G�35� �-���'��(IK �&'*t�4il�h3��Nx(u�d;�$q�Bt+��)�P�@��S13>�������L�W��A��;X\::����j�[uA�bap |c��i�!t�ߋ��g�=��Nn2�al`��cy (M��'���KD��20����#@� ςc�
This content is intended for audience within the US only. 4261 0 obj
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The ACCLARENT AERA ® Eustachian Tube Balloon Dilation System, first-of-its-kind, is a safe and minimally invasive treatment for ETD. Important Safety Information. 4243 0 obj
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All Rights Reserved, We use cookies on this site to enhance your user experience. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. All Rights Reserved. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings and precautions described for this device. The ACCLARENT AERA ® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in adults ages 18 and older.
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