Balloon REmodeling Antrostomy THErapy Study

Exclusion Criteria

• •Evidence of chronic posterior ethmoid, sphenoid or frontal sinusitis
• •Inability to understand the study or a history of non-compliance with medical advice
• •Unwilling or unable to sign Informed Consent Form (ICF)
• •Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies)
• •History of any cognitive or mental health status that would interfere with study participation
• •Previous sinus surgery or intervention including sinuplasty
• •Pregnant women
• •Severe septal deviation causing obstruction of the ostiomeatal unit
• •History of primary ciliary dysfunction
• •Hemophilia
• •Currently undergoing or in the past 6 months had undergone chemotherapy for cancer or radiation therapy in the head or neck region
• •History of cystic fibrosis
• •Known Sampter's Triad (aspirin sensitivity, asthma, sinonasal polyposis)
• •Known sinonasal tumors or obstructive lesions
• •History of mid facial fractures or orthognathic surgery (does not include nasal fracture)
• •History of insulin dependent diabetes
• •Not able to stop anti-coagulant (e.g., warfarin) until the International Normalized Ratio(INR) is below 1.5
• •Not able to stop anti-platelet (e.g., clopidogrel, aspirin, etc.) for at least 14 days prior to study procedure
• •Not able to stop any non-steroidal anti-inflammatory medications and homeopathic medications for at least 14 days prior to the study procedure
• •Presence of nasal polyps that may interfere with the treatment procedure
• •Presence of features consistent with sinus fungal disease on CT or physical examination