Entellus Launches New Sinus Treatment Device; Prepares To Release Data From Randomized Study

Article preview from Medtech Insight - February, 2013

While launching a new balloon-based device to treat chronic sinusitis, Entellus Medical Inc.  revealed it would release details on an important clinical study in July.

 Entellus Launches New Sinus Treatment Device; Prepares To Release Data From Randomized Study

Article preview from Medtech Insight - February, 2013

While discussing the recent launch of the XprESSLoProfile Multi-Sinus Dilation Tool, Entellus Medical Inc.’s CEO Brian Farley told Medtech Insight that data from the company’s randomized comparative study will be presented in July. Farley says Entellus plans to release the first six months of patient follow-up data from a randomized clinical trial comparing in-office, balloon-based treatment of chronic sinusitis with hospital-based functional endoscopic sinus surgery (FESS).

Although acceptance of balloon-based therapies for sinus treatment is increasing among otolaryngologists, both physicians and insurers have been asking for more clinical data, and specifically for randomized, comparative studies. The Entellus study involves 132 patients treated either with FESS or one of Entellus’ balloon devices. The data will be presented at the Second Annual American Rhinologic Society Summer Sinus Symposium, to be held in Chicago in July.

Positive results could help increase interest in products like Entellus’ new XprESS LoProfile, which received 510(k) clearance from the US Food and Drug Administration in 2012 and was launched by the company late last month. The device is a smaller, more dexterous version of the original balloon-based XprESS Multi-Sinus Dilation Tool, and Farley says the new design allows better access to tight sinus spaces where dilations can be performed to create drainage paths. The product features a small, atraumatic ball tip that allows light palpation of tight sinus passages. Additionally, the device is shapeable, which means it can be customized to each patient’s anatomy to more easily treat the frontal, sphenoid, and maxillary sinuses.

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