Study Demonstrates Benefits of Balloon Sinus Dilation Surgery for Sinusitis Patients

Randomized trial results published in The American Journal of Rhinology & Allergy confirm that balloon dilation of narrowed or obstructed sinus drainage paths is a safe and effective alternative to traditional sinus surgery in cases where traditional medical therapy has failed. Sinusitis patients treated with an Entellus balloon sinus dilation procedure had similar levels of long term symptom relief as surgically treated patients. However, patients treated with balloon sinus dilation recovered faster, used less prescription pain medication, and had less bleeding than patients treated with sinus surgery. This study affirms the role of balloon sinus dilation in the continuum of care for patients with uncomplicated sinusitis.

The American Journal of Rhinology & Allergy article, “Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial,” includes results from the first clinical trial (called REMODEL) with sufficient statistical power to compare balloon sinus dilation to traditional functional endoscopic sinus surgery (FESS) for the treatment of chronic or recurrent acute sinusitis.

The REMODEL trial demonstrated that balloon sinus dilation offers a better patient experience compared to FESS. Patients treated with balloon dilation experienced significantly fewer post-procedure debridements versus FESS, with only 8 percent of balloon patients requiring debridements versus 74 percent of FESS patients. In addition, balloon patients experienced 70 percent faster recovery, averaging 1.6 days to return to normal activities versus 4.8 days for traditional surgery patients. Finally, short term symptom improvement was better for balloon patients, with 59 percent experiencing symptom improvement at one week compared to 35 percent for FESS patients.

“Patients who have repeated or prolonged bouts of sinusitis that are not well managed by medical therapy have generally had two primary options for treatment,” Entellus Medical CEO Brian Farley said. “Historically patients could try yet another round of medical therapy with antibiotics and steroids to treat their sinus infection and sinusitis, or they could undergo endoscopic sinus surgery where an ENT [ear, nose and throat] physician treats the patient in an operating room and surgically removes portions of the sinus mucosal tissue to open blocked sinus drainage paths. As shown in the REMODEL trial, many patients with uncomplicated sinusitis do not need to progress to surgery to get relief. Instead, patients can undergo a balloon sinus dilation procedure that can be performed in less than an hour in the doctor’s office. Standalone balloon sinus dilation as performed in the REMODEL trial does not involve any surgical cutting and therefore preserves the sinus mucosa as the drainage paths are enlarged by a balloon that is briefly inserted into the nose and endoscopically guided to a blocked sinus drainage path where it is inflated for a few seconds and removed, leaving behind an opened sinus drainage pathway.”

“Physicians can now treat appropriate sinusitis patients with balloon dilation with the confidence of knowing that symptom relief is comparable to traditional sinus surgery while providing patients a better overall experience than surgery due to quicker recovery, less bleeding, less pain medication, fewer post-operative debridements, and no need for a visit to the hospital or surgery center. All of this contributes not only to a better patient experience, but to a less costly treatment for the patient and our healthcare system,” Farley concluded.

Based in Plymoth, Minn., Entellus Medical Inc. develops solutions for the minimally invasive treatment of chronic and recurrent sinusitis patients.