Novel Tx for chronic rhinosinusitis

October 6, 2008
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<p>Entellus Medical has launched FinESS&#8482;, its new procedure for the treatment of maxillary or maxillary and anterior ethmoid sinuses in patients with chronic rhinosinusitis (CRS) in whom medical treatment has not been successful. Cleared by the FDA in April of 2008, this procedure is less invasive than traditional functional endoscopic sinus surgery (FESS), causes little or no bleeding and pain, does not require general anesthesia, and results in minimal recovery time for patients. </p> <p>FinESS is designed to enlarge the maxillary sinus ostium and ethmoid infundibulum using a small balloon catheter for dilation and a microendoscope for visualization. The sinuses are directly accessed from a site under the lip through the use of a mini-trocar, eliminating the need to navigate nasal passages and remove delicate bone and tissue. This approach also eliminates the need for fluoroscopy.<br>&nbsp;<br>An ongoing prospective, nonrandomized, multicenter study is evaluating the safety and efficacy of FinESS, as well as the feasibility of performing it under local anesthesia. The study is designed to enroll 100 patients and is expected to be completed in December 2009. Efficacy endpoints for the study, which is called Balloon REmodeling Antrostomy THErapy (BREATHE I), include improvement in post-treatment Sino-Nasal Outcome Test-20 (SNOT-20) scores and patency of the treated area, as determined by CT radiographic imaging. </p> <p>Study participants have CRS of the maxillary sinuses alone or maxillary and anterior ethmoid sinuses, with evidence of air/fluid level within the maxillary antrum or narrowing of the outflow tract of the maxillary sinus ostium or infundibulum (at least 2 mm of mucosal thickening in the maxillary sinus antrum). They must be at least 18 years of age. Exclusion criteria include evidence of chronic posterior ethmoid, sphenoid, or frontal sinusitis; features consistent with fungal sinusitis; and previous sinus surgery. </p> <p>Baseline evaluation for the study includes CT imaging after maximal medical therapy and symptom assessment (SNOT 20). Interim results in 30 patients show that 55 of 58 (94.8%) maxillary ostia were successfully treated; 97% of the procedures were completed under local anesthesia with or without minimal IV sedation. There were no device-related serious adverse events or unanticipated adverse device effects. </p> <p>The researchers conclude that &#8220;transantral balloon dilation of the osteomeatal complex under local anesthesia appears to be a safe and effective technique for managing isolated maxillary or maxillary and anterior ethmoid sinusitis and can potentially be performed safely in an office setting.&#8221;</p> <p>Entellus has developed a portable synthetic head model that will be used by the company&#8217;s representatives in training physicians to perform the procedure at their offices or other facilities. Entellus is working to expand third-party reimbursement to include payment for the procedure when performed in physicians&#8217; offices. It is already covered by many insurance plans when performed in hospital outpatient departments and ambulatory surgery centers.</p>