Michael Barbella, Managing Editor04.25.24
Just one treatment with Aerin Medical Inc.'s RhinAer device can improve chronic rhinitis symptoms for 24 months, according to 24-month results from RHINTRAC, a randomized, sham-controlled clinical trial. The study findings build on the previously published results of two separate studies that also demonstrated significant, sustained improvement with RhinAer treatment.1,2
“Chronic rhinitis treatment has been a longstanding challenge due to the limitations of medical therapy and the historical lack of minimally invasive, comprehensive procedure options,” said Pablo Stolovitzky, M.D., adjunct assistant professor, Department of Otolaryngology, Emory University; CEO of ENT of Georgia North, Atlanta; and principal RHINTRAC trial investigator. “It is significant to add high-level evidence reinforcing the efficacy and durability of RhinAer, which provides a well-studied solution for those enduring the burdens of chronic rhinitis.”
ENTs use RhinAer to directly interrupt overactive nerve signals which contribute to symptoms that can be difficult to treat with medications alone in patients suffering from chronic rhinitis. RHINTRAC, a multi-center randomized study, enrolled 117 patients with chronic rhinitis symptoms of at least six months duration, commonly with a poor response to medical therapy. This publication reports patient outcomes through two years, including treatment response, chronic rhinitis symptom burden, quality of life, medication use and adverse events for all treated patients.
More than 87% of patients responded to treatment and patients showed sustained improvement in chronic rhinitis symptoms at two years. Additional findings published in IFAR included:
Rhinitis, or inflammation of the nose's mucous membranes, can include symptoms such as runny nose, congestion, itching, sneezing, coughing, and post-nasal drip. Chronic rhinitis, when symptoms last more than four consecutive weeks, can be challenging to treat and may significantly lower a person’s quality of life.
Using temperature-controlled, radiofrequency technology, RhinAer features a thin, wand-like stylus that is inserted in the nostril to deliver therapeutic benefits while sparing surrounding tissues. RhinAer directly disrupts the posterior nasal nerve (PNN) that triggers excessive mucus production, treating an underlying cause of chronic rhinitis. RhinAer provides ENT physicians with a solution for treating chronic rhinitis, addressing sources of rhinorrhea (runny nose) and congestion. The procedure can be performed with a local anesthetic during an office visit, with no incisions, minimal to no downtime, and little discomfort. RhinAer initially received FDA 510(k) clearance in December 2019 and CE Mark in 2020.
Aerin Medical is privately held, venture-backed company, with U.S. offices in California and Texas. The company’s products, VivAer for nasal airway obstruction and RhinAer for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with technologies that are appealing alternatives to invasive surgery. More than 100,000 patients have been treated with Aerin Medical products to date.
References
1 Ehmer D, McDuffie CM, McIntyre JB, et al. Long-term Outcomes Following Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Chronic Rhinitis. Allergy & Rhinology. (2022);13. doi:10.1177/21526575221096045.
2 Lee, J.T., Abbas, G.M., Charous, D.D., Cuevas, M., Göktas, Ö., Loftus, P.A., Nachlas, N.E., Toskala, E.M., Watkins, J.P. and Brehmer, D. Two-Year Outcomes After Radiofrequency Neurolysis of Posterior Nasal Nerve in Chronic Rhinitis. The Laryngoscope. (2023) https://doi.org/10.1002/lary.31120.
“Chronic rhinitis treatment has been a longstanding challenge due to the limitations of medical therapy and the historical lack of minimally invasive, comprehensive procedure options,” said Pablo Stolovitzky, M.D., adjunct assistant professor, Department of Otolaryngology, Emory University; CEO of ENT of Georgia North, Atlanta; and principal RHINTRAC trial investigator. “It is significant to add high-level evidence reinforcing the efficacy and durability of RhinAer, which provides a well-studied solution for those enduring the burdens of chronic rhinitis.”
ENTs use RhinAer to directly interrupt overactive nerve signals which contribute to symptoms that can be difficult to treat with medications alone in patients suffering from chronic rhinitis. RHINTRAC, a multi-center randomized study, enrolled 117 patients with chronic rhinitis symptoms of at least six months duration, commonly with a poor response to medical therapy. This publication reports patient outcomes through two years, including treatment response, chronic rhinitis symptom burden, quality of life, medication use and adverse events for all treated patients.
More than 87% of patients responded to treatment and patients showed sustained improvement in chronic rhinitis symptoms at two years. Additional findings published in IFAR included:
- Eighty-one percent of patients reported improvements in quality of life, as assessed by the Mini-Rhinoconjunctivitis Quality of Life questionnaire, compared to baseline.
- Patient treatment response, including symptom reductions, improved through two years, with a 64.6% improvement over baseline in reflective total nasal symptom score (rTNSS). All individual symptom scores (runny nose, congestion, sneezing and nasal itching) were significantly improved over baseline through two years.
Rhinitis, or inflammation of the nose's mucous membranes, can include symptoms such as runny nose, congestion, itching, sneezing, coughing, and post-nasal drip. Chronic rhinitis, when symptoms last more than four consecutive weeks, can be challenging to treat and may significantly lower a person’s quality of life.
Using temperature-controlled, radiofrequency technology, RhinAer features a thin, wand-like stylus that is inserted in the nostril to deliver therapeutic benefits while sparing surrounding tissues. RhinAer directly disrupts the posterior nasal nerve (PNN) that triggers excessive mucus production, treating an underlying cause of chronic rhinitis. RhinAer provides ENT physicians with a solution for treating chronic rhinitis, addressing sources of rhinorrhea (runny nose) and congestion. The procedure can be performed with a local anesthetic during an office visit, with no incisions, minimal to no downtime, and little discomfort. RhinAer initially received FDA 510(k) clearance in December 2019 and CE Mark in 2020.
Aerin Medical is privately held, venture-backed company, with U.S. offices in California and Texas. The company’s products, VivAer for nasal airway obstruction and RhinAer for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with technologies that are appealing alternatives to invasive surgery. More than 100,000 patients have been treated with Aerin Medical products to date.
References
1 Ehmer D, McDuffie CM, McIntyre JB, et al. Long-term Outcomes Following Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Chronic Rhinitis. Allergy & Rhinology. (2022);13. doi:10.1177/21526575221096045.
2 Lee, J.T., Abbas, G.M., Charous, D.D., Cuevas, M., Göktas, Ö., Loftus, P.A., Nachlas, N.E., Toskala, E.M., Watkins, J.P. and Brehmer, D. Two-Year Outcomes After Radiofrequency Neurolysis of Posterior Nasal Nerve in Chronic Rhinitis. The Laryngoscope. (2023) https://doi.org/10.1002/lary.31120.