Two-year follow-up results from the AERWAY trial showed a significant and long-term improvement in nasal airway obstruction symptom burden due to nasal valve collapse for people treated with Aerin Medical’s VivAer. 

The results are published Laryngoscope Investigative Otolaryngology.

The AERWAY outcomes demonstrated the ongoing effectiveness and safety of VivAer, with treated patients reporting sustained two-year symptom improvement that remained consistent with three-month, six-month, and one-year results. A non-invasive technology, VivAer uses patented, temperature-controlled radiofrequency energy to provide relief from nasal obstruction. 

Key findings include:

  • Statistically significant and sustained improvement in symptom burden was achieved in all subpopulations including nasal valve collapse patients with untreated septal deviations and either static or dynamic nasal valve collapse
  • 90.1% of the patients were responders and improvements in total Nasal Obstruction Symptom Evaluation (NOSE) Scale scores were maintained from time of treatment through two years
  • Usage of oral medications, nasal sprays, and breathing strips decreased at two years compared to baseline
  • Treatment with VivAer was well-tolerated, with no serious adverse events related to the procedure and/or device

“The AERWAY long-term data showed that VivAer delivered relief to 90% of patients suffering from [nasal valve collapse],” says William Yao, MD, AERWAY’s principal investigator from the department of otorhinolaryngology – head and neck surgery at McGovern Medical School at UTHealth Houston, in a release. “These results demonstrate that VivAer offers a useful option for otolaryngologists and patients, as the evidence showed statistically significant and sustained improvement even for patients with other untreated anatomical factors like septal deviation.”

Earlier this year the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) issued a position statement noting that nasal valve collapse is a structural issue that cannot effectively be handled with medical treatment (i.e., intranasal steroids). The academy noted that office-based techniques like radiofrequency treatment can stabilize the nasal valve, optimize nasal valve collapse patient outcomes, and be performed either as a standalone procedure or in combination with other procedures to potentially avoid multiple surgeries.

The AERWAY study, a prospective, multi-center trial, followed patients after a single treatment session with VivAer and collected two-year outcomes for 91 patients. Before treatment, all participants exhibited extreme or severe NAO, based on the validated NOSE Scale score, with NVC as a primary contributor to their symptoms.

“The positive two-year outcomes from the AERWAY trial build upon published VivAer clinical results, including superior symptom improvements in a randomized controlled trial and a four-year study showing long-term durability of a single VivAer treatment,” says Matt Brokaw, CEO of Aerin Medical, in a release. “We are proud to see the growing body of evidence that demonstrates the safety, effectiveness, and predictability of VivAer for patients suffering from [nasal airway obstruction] due to [nasal valve collapse], and we thank the numerous physician investigators who have confirmed benefits for their patients.”

Photo credit: Two-year data published online in Laryngoscope Investigative Otolaryngology shows a statistically significant and sustained improvement in the symptom burden of those with nasal airway obstruction following a single treatment with VivAer.

Photo: Business Wire