Aerin Medical today announced positive two-year data backing the use of its non-invasive nasal airway obstruction (NAO) treatment.
Mountain View, California-based Aerin Medical evaluated its VivAer system in the AERWAY clinical trial.
VivAer, which holds both CE mark and FDA 510(k) approval, uses 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 featured on Medical Design & Outsourcing’s list of 20 medical device startups you need to know in 2020.
This trial looked at VivAer in the treatment of patients with severe or extreme NAO due to nasal valve collapse (NVC). Results published in Laryngoscope Investigative Otolaryngology demonstrated significant, long-term improvement in NAO symptom burden.
According to a news release, the outcomes showed the ongoing effectiveness and safety of VivAer. Treated patients reported sustained two-year symptom improvement that remained consistent results ranging to as long as one year.
“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,” said Matt Brokaw, CEO of Aerin Medical. “We are proud to see the growing body of evidence that demonstrates the safety, effectiveness and predictability of VivAer for patients suffering from NAO due to NVC, and we thank the numerous physician investigators who have confirmed benefits for their patients.”
More about the results from the Aerin Medical trial
The AERWAY prospective, multi-center trial, followed patients after a single VivAer treatment. It collected two-year outcomes for 91 patients. Before treatment, all participants exhibited extreme or severe NAO with NVC as a primary contributor to their symptoms.
Key findings from the trial included statistically significant and sustained improvement in symptom burden for all subpopulations. That included NVC patients with untreated septal deviations and either static or dynamic NVC.
Additionally, 90.1% of patients responded to treatment, with improvements maintained from time of treatment through two years. Aerin Medical measured the improvements by total Nasal Obstruction Symptom Evaluation (NOSE) Scale scores.
The use of oral medications, nasal sprays and breathing strips decreased at two years compared to baseline. Aerin Medical reported that its treatment was well tolerated. The company saw no serious adverse events related to the procedure and/or device.
Last year, the company reported positive four-year data for the VivAer system.
“The AERWAY long-term data showed that VivAer delivered relief to 90% of patients suffering from NAO,” said Dr. William Yao, AERWAY’s principal investigator from the Department of Otorhinolaryngology – Head and Neck Surgery at McGovern Medical School at UTHealth Houston. “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.”