A new study provides further support for the use of Balloon Sinus Dilation as a treatment option that might render traditional sinus surgery a thing of the past, say the balloon makers.
Background
Chronic sinusitis is one of the most common health problems, being more prevalent than heart disease and asthma. Chronic symptoms can have Quality of Life consequences including including facial pain and pressure, teeth pain, headaches, fatigue, loss of smell, and sinus infections.
Traditional surgical treatments of chronic sinusitis such as FESS involve cutting and removal of sinus tissue to open narrowed sinus drainage pathways. In contrast, sinus balloon dilation preserves sinus tissue by opening obstructed or narrowed drainage pathways with a high pressure balloon that is temporarily inserted into the nose, placed into the obstructed area and inflated for a few seconds before deflating and removing the balloon.
New results have been presented from what balloon sinusitis specialist Entellus Medical claims is the first prospective, multi-center, randomized, controlled trial with sufficient statistical power to compare sinus balloon dilation procedures performed in the office to FESS for the treatment of medically refractory chronic rhinosinusitis. The trial, tagged REMODEL and published in the American Journal of Rhinology and Allergy is entitled; “Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up” and shows in-office treatment using balloon sinus dilation is as effective as functional endoscopic sinus surgery (FESS) for patients with chronic sinusitis.
An earlier report of the REMODEL study at six-month follow-up showed that standalone balloon sinus dilation procedures offer significant advantages compared to traditional surgery, so it’s perhaps unsurprising to see the 12 month data similarly supporting the procedure.
Inclusion criteria showed that Patients had suffered sinusitis symptoms for an average of over 12 years prior to treatment and patients treated in the balloon arm of the study reported a mean of 5.2 sinusitis episodes in the year immediately prior to treatment. However in the year after treatment with balloon sinus dilation, patients reported an average of only 1.0 episode of sinusitis, and 98% of balloon procedure patients did not require revision surgery. In addition, CT scans showed that 97% of sinus drainage paths were unobstructed and open at 1-year follow-up. These results were not statistically different than the results seen following FESS.
Investigator comments
According to the lead author Dr. Nadim Bikhazi, “These results prove that patients experience significant, lasting sinus symptom improvement with office balloon dilation that is as effective as FESS. The quality of life for patients is dramatically improved, as they are able to quickly return to their daily activities and experience distinct symptom relief.”
Company comments
“These results show that the Entellus balloon technology is comparably effective versus the standard of care and a viable treatment for patients with uncomplicated sinusitis who are seeking an effective, minimally invasive option when medical therapy fails to address their symptoms,” said Brian Farley, CEO of Entellus Medical.
“The REMODEL study is the seventh clinical study performed by Entellus Medical which together resulted in over 450 patients followed for 6, 12, or 24 months after treatment. Study upon study shows a significant level of symptom improvement, low rate of revision surgery, reduction of sinusitis episodes, and reductions in sinus infections and physician visits in the year after standalone balloon sinus dilation. The REMODEL study shows that the prior non-randomized studies produced results that are comparable to those seen in the more scientifically rigorous REMODEL study and thus validate the results from the other six studies completed by the company. Lastly, in addition to the clinical advantages of balloon procedures demonstrated in this study, the costs to the patient and the healthcare system are substantially lower when the procedure is performed in the ENT physician’s office compared to the patient receiving traditional sinus surgery in a hospital or surgery center.”
Source: Entellus Medical, Business Wire
