Healthcare Industry News:  sinusitis 

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 News Release - July 25, 2013

Study Shows Benefits of Balloon Sinus Dilation versus Traditional Sinus Surgery for Chronic Sinusitis

MINNEAPOLIS--(Healthcare Sales & Marketing Network)--Results from a new randomized study demonstrate the benefits of non-surgical balloon sinus dilation procedures compared to traditional sinus surgery for chronic sinusitis patients. Dr. Jeff Cutler, Colorado Sinus Institute in Denver, CO, presented the study results during the American Rhinologic Society’s Summer Sinus Symposium in Chicago, Illinois.

This study, sponsored by Entellus Medical, is the first prospective, multi-center, randomized, controlled trial with sufficient statistical power to compare sinus ostial balloon dilation procedures performed in the office to traditional functional endoscopic sinus surgery (FESS) for the treatment of medically refractory chronic rhinosinusitis.

Traditional surgical treatment of chronic sinusitis routinely involves cutting and removal of tissue to open narrowed sinus drainage pathways whereas sinus balloon dilation preserves sinus tissue by opening the drainage pathways with a balloon that is temporarily inserted into the nose and inflated for a few seconds before deflating and removing the balloon. The REMODEL study (Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up) sought to measure the comparative results of sinus surgery versus the balloon dilation procedure in patients with uncomplicated chronic sinusitis.

The REMODEL study involved treatment of 92 patients. sinusitis symptoms, patient recovery, and need for subsequent procedures were measured, and 91 of the 92 treated patients returned for follow-up assessment six months after treatment for a compliance rate of 99%. Symptom reduction for patients treated with the balloon dilation procedure was demonstrated to be non-inferior to treatment with sinus surgery and 98% of balloon procedure patients did not require revision surgery.

According to Dr. Cutler, “These results prove that patients experience significant sinus symptom improvement with office balloon dilation that is as effective and durable as FESS. Patients are impressed how quickly their sinus symptoms are relieved and how fast they are able to return to normal daily activities following the balloon dilation procedure.”

The REMODEL study showed that standalone balloon sinus dilation procedures offer significant advantages compared to FESS. Patients treated with balloon dilation experienced significantly fewer post-procedure debridements versus FESS. In addition, the occurrence of postoperative nasal bleeding, duration of prescription pain medication use, recovery time and short-term symptom improvement were all significantly better for patients treated with balloon dilation than with sinus surgery.

“These results show that the Entellus balloon technology utilized in the physician’s office enables sinus dilation procedures to offer patients many clinical advantages compared to sinus surgery, while providing the convenience of avoiding operating room procedures,” said Brian Farley, CEO of Entellus Medical. “With excellent efficacy and fast patient recovery, we believe office balloon dilation procedures now belong squarely in the continuum of care as a logical next step after patients with uncomplicated sinusitis fail to get sustained relief from medical therapy.” Mr. Farley also commented, “In addition to the clinical advantages of balloon procedures demonstrated in this study, it is noteworthy that balloon sinus treatment in the physician’s office lowers procedure costs for both patients and the healthcare system. This results in balloon sinus procedures providing an excellent treatment option for many patients with chronic sinusitis.”

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 for office-based balloon dilation of narrowed sinus drainage 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 www.EntellusMedical.com.


Source: Entellus Medical

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