PARAGON Study Shows NEUROMARK® Treatment Benefits Allergic and Nonallergic Rhinitis Patients
Greg E. Davis, MD1, Randall A. Ow, MD2, David M. Yen, MD3, Ellen M. O’Malley, MS4, and Anthony G. Del Signore, MD, PharmD5
Abstract
Objective: Chronic rhinitis substantially impacts a person’s quality of life. We evaluated a novel, multipoint, impedance-controlled, radiofrequency ablation device for the treatment of chronic rhinitis. Methods: This was a prospective, multicenter, single-arm clinical study of posterior nasal nerve ablation in adults with chronic rhinitis. The primary efficacy endpoint was the change in reflective Total Nasal Symptom Score (rTNSS) at 6-month follow-up. Additional assessments included the Eustachian Tube Dysfunction Questionnaire (ETDQ-7), Nasal Obstruction Symptom Evaluation (NOSE), and mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ). The primary safety endpoint was the incidence of related serious adverse events. Results: Seventy-nine of 80 enrolled participants completed 6-month follow-up. Statistically significant improvements were observed for mean change in rTNSS (−4.2), ETDQ-7 (−1.2), NOSE (−33.5), and mini-RQLQ (−1.8; P < .0001 for all). Allergic and nonallergic rhinitis subgroups demonstrated significant improvement in all assessments (P < .0001) with no significant differences between subgroups. Higher baseline rTNSS was associated with greater improvements at follow-up. One serious adverse event of epistaxis was reported. Conclusions: The results of this study demonstrate the efficacy and safety of a multipoint, impedance-controlled, radiofrequency ablation device for the treatment of chronic rhinitis. Significant improvements were observed in rTNSS, ETDQ-7, NOSE, and mini-RQLQ assessments.
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About the NEUROMARK® System
The NEUROMARK® System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radio frequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The system is engineered to gently apply controlled low-power Radio Frequency (RF) energy to target regions of the nasal cavity to disrupt the parasympathetic nerve signals in order to reduce the inflammatory response, thereby reducing core symptoms such as congestion and rhinorrhea.
About Neurent Medical
Neurent Medical is pioneering innovative treatments for chronic inflammatory sinonasal diseases by targeting and safely disrupting hyperactive autonomic nerves that drive underlying inflammation. Its proprietary NEUROMARK® technology with a unique design and advanced smart algorithmic control, allows physicians to precisely target and safely disrupt multiple underlying nerve branches in a single procedure to alleviate chronic rhinitis symptoms and improve patient quality of life. The venture capital-backed company is headquartered in Galway, Ireland, with US HQ in Braintree, MA. For more information visit www.neurentmedical.com.
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PAM156r01 September 2024
