

- 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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