Aerin Medical today announced published results from a four-year clinical trial of its VivAer treatment for nasal airway obstruction (NAO).
Sunnyvale, California-based Aerin designed VivAer, which holds both CE mark and FDA 510(k) approval, to use patented, temperature-controlled radiofrequency energy through a thin, wand-like stylus attached to a console. The stylus is inserted via the nostril to gently remodel the nasal tissue and improve airflow. Aerin Medical was included in MassDevice’s list of hottest startups in 2020.
Results from the trial, published in the International Forum of Allergy & Rhinology, showed the long-term durability of VivAer in those with NAO due to nasal valve collapse (NVC).
The follow-up study demonstrated that patients experienced significant and sustained improvement in symptoms of NAO through four years following a single treatment of NVC with VivAer. The publication adds to a growing body of evidence supporting the safety and efficacy of VivAer, which includes three-month data published about a year ago.
Aerin evaluated the use of VivAer in 29 patients with chronic severe or extreme NAO with NVC, with the patients having participated in a prospective multicenter study with follow-ups at 6, 12, 18 and 24 months. The study was extended to follow the cohort out to 48 months.The average baseline (pre-procedure) Nasal Obstruction Symptom Evaluation (or “NOSE” score, a gold-standard measure of nasal obstruction), of participants was 81.0, which is considered in the “extreme” category (score of 80-100).
In the follow-up, NOSE scores decreased from 81 at baseline to 25.7 after 48 months (68.3% change), while 96.4% of patients were treatment responders at 48 months, based on a greater-than 15-point improvement on the NOSE scale. That rate was similar to observations at 12, 24 and 36 months.
“These study results represent the longest-term published outcomes for treatment with VivAer,” Aerin Medical CEO Matt Brokaw said. “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.”