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MedTech Outlook | Thursday, August 19, 2021
RhinAer is a temperature-controlled, revolutionary radiofrequency device that disrupts nerve signals that cause chronic rhinitis symptoms.
FREMONT, CA: Aerin Medical, a company committed to providing Ear Nose and Throat (ENT) physicians with non-invasive solutions for the treatment of chronic nasal conditions, recently announced that the American Journal of Rhinology & Allergy has published positive one-year results from a trial assessing the safety and efficacy of RhinAer in patients with chronic rhinitis. RhinAer is a temperature-controlled, revolutionary radiofrequency device that disrupts nerve signals that cause chronic rhinitis symptoms. Symptom severity dropped dramatically in the first two weeks after a single RhinAer treatment and remained low during the one-year follow-up.
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“The outcomes of this study demonstrate the robust and durable benefits of RhinAer, and they reinforce the effectiveness of targeting the posterior nasal nerve area with temperature-controlled radiofrequency to treat chronic rhinitis,” said V. Vasu Kakarlapudi, M.D., MBA, of Advanced ENT and Allergy in Louisville, Kentucky, and principal investigator of the study. “RhinAer offers patients a lasting, non-invasive option to effectively treat their condition without complex surgery.”
The 50 adult patients in the prospective, single-arm, multi-center trial had moderate to severe rhinitis symptoms as measured by the 4-point reflecting Total Nasal Symptoms Survey (rTNSS), which scores symptoms such as runny nose, congestion, itching, and sneezing. Patients were followed up on at 2, 4, 12, 26, and 52 weeks after receiving RhinAer treatment and completed a satisfaction survey.
The study’s primary goal was reached, with participants receiving RhinAer seeing clinically significant decreases in chronic rhinitis symptoms three months after therapy, with symptom improvements lasting up to one year. The following are some of the findings:
The mean rTNSS score increased from 8.5 at baseline to 3.6 at the end of the study (p0.001). The rTNSS subscores (runny nose, nasal congestion, itching, and sneezing), postnasal drip, and chronic cough scores yielded similar results.
· 80.9 percent of patients experienced symptom progress of at least 30 percent relative to baseline at one year.
· 100 percent of patients experienced at least one rTNSS point advancement relative to baseline, showcasing that all patients experienced some measurable symptom relief.
There were no significant device or procedure-related adverse events during the treatment. According to the authors, no headaches related to the device or treatment were reported throughout the experiment. RhinAer was also helpful in giving symptom alleviation to patients with allergic and non-allergic rhinitis, according to subgroup analysis data.
“Historically, options have been limited for the large percentage of chronic rhinitis patients unresponsive to medication,” said Matt Brokaw, CEO, Aerin Medical. “RhinAer provides otolaryngologists an effective, non-invasive solution for appropriately selected chronic rhinitis patients who have been challenging to treat, and fits seamlessly into any practice setting.”
Rhinitis, or inflammation of the mucous membrane of the nose, affects about 30 percent of the population in the United States. Runny nose, congestion, itching, sneezing, coughing, and postnasal drip are all symptoms. When symptoms linger for more than four weeks, chronic rhinitis can be difficult to manage. RhinAer is a device used by ENTs to help relieve chronic rhinitis symptoms by interrupting nerve signals directly.
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