Therapeutic devices developer Aerin Medical has unveiled positive four-year results from a VivAer clinical trial published in the International Forum of Allergy & Rhinology.
VivAer is a non-invasive technology that leverages proprietary, temperature-controlled radiofrequency radiation to permanently treat nasal blockage.
The outcome supported the long-term durability of VivAer treatment against nasal airway obstruction (NAO) due to nasal valve collapse (NVC).
Patients in the follow-up research saw a significant and long-lasting improvement in their NAO symptoms four years after receiving just one VivAer therapy for NVC.
Aerin Medical said that the published results show that VivAer is both safe and effective.
The firm recruited 29 patients with chronic severe or extreme NAO with NVC, with the patients having participated in a prospective multi-centre study with follow-ups at six, 12, 18, and 24 months.
This patient cohort was followed for an additional 48 months as part of the research.
The average baseline Nasal Obstruction Symptom Evaluation (NOSE) of participants was 81.0, which is considered in the “extreme” category.
According to the trial, participants who received VivAer therapy had significant post-treatment gains in their mean total NOSE scores that persisted for 48 months.
Among the participants, the NOSE score decreased from 81.0 at baseline to 25.7 after 48 months and 96.4% of patients were treatment responders at 48 months, based on a greater-than 15-point improvement on the NOSE scale.
Aerin Medical CEO Matt Brokaw said: “These study results represent the longest-term published outcomes for treatment with VivAer.
“We appreciate the efforts of the physician investigators and trial patients who have contributed over the past four years to demonstrate the significant, long-term benefits of temperature-controlled radiofrequency for chronic nasal obstruction caused by nasal valve collapse.”
Earlier this month, the company published the two-year results from a trial evaluating the safety and efficacy of the RhinAer device in patients with chronic rhinitis.
