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  • Have you been diagnosed with chronic sinusitis?
  • Have you taken medications such as antibiotics,
    steroids and decongestants but found their
    effectiveness to be short-lived?

You may be eligible to participate in a clinical research study called BREATHE I sponsored by Entellus Medical Inc. (www.entellusmedical.com).

BREATHE I (Balloon REmodeling Antrostomy THErapy Study) is an approved, actively enrolling clinical research study that is evaluating the long-term safety and performance of a new marketed medical device called the RS-Series System.

The RS-Series System is intended to reopen blocked sinuses behind the cheek bones and the eyes using a small balloon similar to those used to open blocked heart arteries. This balloon is designed to widen and reshape the passages leading to blocked sinuses that may provide relief from the problems associated with Chronic Sinusitis.

The RS-Series System was approved in April 2008 to treat patients with Chronic Sinusitis. This means that the RS-Series System is available to all doctors in United States and that you can receive the same treatment with the same device from your doctor without participating in the clinical research study. However, information gathered from this clinical research study will help the sponsor of this study, Entellus Medical Inc., to continue to monitor the safety and performance of the RS-Series System and possible further improvement in the device and procedure for future sufferers of Chronic Sinusitis.


 
 


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