Entellus Medical® Announces First Enrollment In FinESS™ Registry To Assess Symptomatic Status Of Rhinosinusitis Treatment Over Time

Main Category: Ear, Nose and Throat
Also Included In: Infectious Diseases / Bacteria / Viruses
Article Date: 07 May 2009 - 7:00 PDT

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Entellus Medical, a Minnesota-based medical technology company, announced the first enrollment in the FinESS™ Registry, a prospective, post-approval Registry study designed to assess subject rhinosinusitis symptomatic status of up to 500 patients treated with FinESS™ Sinus Treatment over time. Up to 25 medical practices in the U.S. may participate in this Registry.

The objective of the Registry is to assess subject rhinosinusitis symptomatic status at pre-treatment, six months and twelve months post-treatment following FinESS™ Sinus Treatment using data collected from validated, self-administered QoL (quality of life) surveys.

Paul A. Cink, M.D. FACS, Midwest Ear, Nose & Throat, Sioux Falls, SD, also a BREATHE I Study Investigator, is a Principle Investigator of the FinESS Registry and site of the first enrollment. "This registry will provide significant symptomatic status data across a broad community sample, which will help us understand the impact of this innovative treatment," said Cink.

About Rhinosinusitis

Rhinosinusitis, also known as sinusitis, is an inflammation of the tissue lining of the sinuses that also expands into the nasal cavity and afflicts more than 37 million Americans each year. Normally, sinuses are filled with air, but when sinuses become blocked and filled with fluid, pathogens (bacteria, viruses and fungi) can grow and cause an infection. Structural issues such as narrowed drainage anatomy are often associated with sinusitis.

About FinESS™ Sinus Treatment

FinESS Sinus Treatment is a less-invasive treatment option to break the cycle of chronic rhinosinusitis (CRS). It is for patients whose symptoms persist or return, despite antibiotics and steroids or for patients who do not need, want or can't have extensive sinus surgery. Unlike extensive sinus surgery FinESS does not require the removal of delicate bone or sinus tissue, resulting in shorter treatment and recovery time with very little pain or bleeding. FinESS can be performed using local anesthetic, with or without mild sedation. Most patients resume normal activity within hours of treatment. Clinical study results published in the American Journal of Rhinology prove the effectiveness of FinESS in keeping treated sinuses open with statistically significant quality of life improvements.

Source
Entellus Medical