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September 10, 2012 at 08:30 AM EDT
Study Shows Physicians can Reliably Access and Dilate Maxillary Sinus Openings with Entellus Medical’s XprESS

Results from a study presented by Dr. David Brodner during the 58th Annual Meeting of the American Rhinologic Society in Washington D.C. demonstrate that both newly trained and experienced users of the Entellus Medical XprESS Multi-Sinus Dilation Tool can consistently and successfully access and dilate the natural maxillary sinus opening without need for tissue removal. These results affirm the unique utility and ease of use of a balloon sinus dilation device to open the most commonly inflamed sinus drainage path without cutting sinus tissue.

Surgical treatment of chronic sinusitis routinely involves cutting and removal of tissue near and at the natural maxillary sinus opening. Use of a balloon and no cutting instruments may potentially reduce bleeding and scarring and enable effective treatment of sinusitis patients in the comfort and convenience of an office setting. Accessing the natural opening of the maxillary sinus without tissue removal can be challenging due to a lack of direct visualization of the sinus opening. The study, “Uncinate Preserving Transnasal Cannulation and Dilation of the Natural Maxillary Ostium in a Cadaveric Model,” evaluated the ability of six physicians to access and dilate the natural maxillary ostia transnasally with the XprESS device after undergoing procedure training. Procedural protocol included adjusting the device tip to a recommended initial 135 degree bend and using tactile feel to confirm tip placement in the natural ostium. Outcomes were documented by observers who were able to visualize the natural opening through a transantral endoscope placed in a second opening via the canine fossa. Each participating surgeon was blinded to all transantral views and did not receive any feedback during each attempt.

A total of 42 maxillary ostia were available for the study and 40 procedures were completed per the procedural training. When procedure training was followed, the success rate at cannulating and dilating the maxillary opening was 97.5%. The high success rate of both experienced and inexperienced XprESS users in this study confirms that transnasal access and dilation of the ethmoid infundibulum and natural maxillary opening is repeatable without tissue removal when using the XprESS sinus balloon device.

According to Dr. Brodner, “The malleable tip of XprESS makes it ideal for reliably treating the maxillary sinus in office as you can quickly configure the device with the anatomically correct angle for treatment of the natural ostium and infundibulum.”

The Entellus XprESS Multi-Sinus Dilation Tool is used for the treatment of the frontal, sphenoid and maxillary sinuses either alone in an office procedure or as part of a traditional sinus surgery. XprESS enables a physician to cost-effectively use balloon dilation to treat multiple sinuses with a single device while potentially reducing the amount of tissue loss as compared to traditional sinus surgical procedures.1,2,3

“This study confirms the research performed by our technical team to show that physicians of all levels of experience can reliably use XprESS to access and dilate the natural maxillary sinus opening,” said Brian Farley, CEO of Entellus Medical. “These results affirm a growing body of experience that demonstrates XprESS is a safe, consistent, and effective treatment for appropriate patients suffering from chronic sinusitis.”

1James Stankiewicz, et.al. Transantral, Endoscopically Guided Balloon Dilation of the Ostiomeatal Complex for Chronic Rhinosinusitis Under Local Anesthesia, Am. J. Rhinol. Allergy 23, 1-00 (2009)
2Ahmet Kutluhan, et.al., Endoscopic Balloon Dilation Sinuplasty Including Ethmoidal Air Cells in Chronic Rhinosinusitis, Annals of Oto, Rhin and Lary 118(12):881-886 (2009).
3Kevin C. Welch, et.al., A Contemporary Review of Endoscopic Sinus Surgery: Techniques, Tools, Outcomes, 119 Laryngoscope 2258-68 (Nov. 2009)

Entellus Medical (www.EntellusMedical.com) provides complete solutions for the minimally invasive treatment of chronic and recurrent sinusitis patients and is leading the way with easy-to-use, cost-effective products designed for office-based balloon dilation of narrowed sinus pathways. With this approach, Entellus sinus dilation products also provide significant efficiency and cost-effectiveness for sinus dilation procedures performed in operating rooms. For more information on XprESS™ Multi-Sinus Dilation Tool, FinESS™ Sinus Treatment, or PathAssist™ sinus confirmation tools visit http://www.EntellusMedical.com.

Contacts:

Entellus Medical
Mike Gaynes, 650-728-0227
media@entellusmedical.com
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