Device Enables Reliable Access and Dilation of Sinus Opening

A new study demonstrates the effectiveness of a balloon sinus-dilation tool to easily, consistently, and successfully access and dilate the most commonly inflamed sinus drainage path, the natural maxillary sinus opening, without the need for tissue removal.

Accessing this sinus opening without tissue removal can be challenging particularly due to a lack of direct visualization. The study presented by Dr. David Brodner at the 2012, 58th Annual Meeting of the American Rhinologic Society in Washington DC (USA), evaluated the ability of six physicians to access, and dilate the natural maxillary ostia transnasally with Entellus Medical’s (Plymouth, MN, USA) XprESS Multi-Sinus Dilation Tool 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. 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 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 device. “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,” said Dr. Brodner.

The Entellus XprESS Multi-Sinus Dilation Tool enables cost-effective use of balloon dilation to treat multiple sinuses with a single device and is used for the treatment of the frontal, sphenoid, and maxillary sinuses either alone in the comfort and convenience of an office setting or as part of a traditional sinus surgery.

“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.”

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Entellus Medical, Inc.