The Food and Drug Administration (FDA) has cleared Neuromark™ Rhinitis Neurolysis Therapy™ for otorhinolaryngology surgery for creation of radiofrequency lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.

The in-office treatment works by disrupting hyperactive parasympathetic nasal nerves using a flexible electrode array that is designed to apply controlled low power radio frequency energy. By targeting these regions of the nasal cavity, the device is able provide symptom relief for patients with chronic rhinitis by halting the inflammatory response.

The approval was based on data from the RELIEVE trial, a prospective, single-arm, safety and technical feasibility study that included 11 adults with chronic rhinitis (allergic or nonallergic).  Results showed that the procedure was successfully completed in all 22 nasal cavities with no serious adverse events. The study population reflective total nasal symptom score (rTNSS) had reduced from 8/15 at baseline to 4/15 at the 6-month follow-up.

“The truth is, medications, sprays and other intranasal procedures are often either ineffective or only offer short-term relief for patients suffering with chronic rhinitis,” said Marc Dubin MD, Scientific Advisor for Neurent Medical. “The FDA clearance of Neuromark™ RNT means otolaryngologists can now offer precise care to patients with chronic rhinitis, while avoiding the trial and error that often goes into treating this condition.”


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References

  1. Neurent Medical receives FDA clearance for NEUROMARK™, a novel multi-point nerve disruption treatment for chronic rhinitis. News release. November 18, 2021. https://www.businesswire.com/news/home/20211118005536/en/Neurent-Medical-Receives-FDA-Clearance-for-NEUROMARK%E2%84%A2-A-Novel-Multi-Point-Nerve-Disruption-Treatment-for-Chronic-Rhinitis.
  2. US Food and Drug Administration 510(k) Summary. Accessed November 19, 2021. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212666.pdf.