Aerin Medical’s VivAer Achieves Another Clinical Validation

New three-year study results reinforce the durability of Aerin Medical Inc.’s VivAer procedure for patients suffering from nasal airway obstruction (NAO) due to nasal valve collapse (NVC). Published in OTO Open, the data confirm that VivAer provides consistent and long-lasting symptom relief.

The prospective, single-arm, multicenter AERWAY trial was conducted at 12 U.S. sites to evaluate the long-term efficacy and safety of temperature-controlled radiofrequency (TCRF) treatment with VivAer. At three years post-procedure, patients showed sustained symptom relief, meaningful reductions in medication use, and no serious device- or procedure-related side effects. These improvements in symptom burden at three years are consistent with outcomes reported at previously assessed intervals of three, six, 12, and 24 months.

Key study findings:

• Sustained Symptom Relief
  • 83.3% of patients were responders, with mean NOSE scores improving by 52.6%
• Low Nasal Valve Reintervention Rate
  • 3.2% of patients required additional procedures targeting the nasal valve at three years
• Excellent Safety Profile
  • No device- or procedure-related serious side effects reported over the three-year follow-up

“These long-term results reinforce VivAer’s potential as a safe and effective long-term solution for patients experiencing nasal airway obstruction,” said William C. Yao, M.D., associate professor at McGovern Medical School at UTHealth Houston and AERWAY principal investigator. “Providing sustained symptom relief through a durable, minimally invasive alternative to traditional surgery may elevate the standard of care available to our patients.”

VivAer is a non-invasive technology that uses patented, temperature-controlled radiofrequency energy and is clinically demonstrated to provide long-term relief from nasal obstruction. VivAer features a thin, wand-like stylus that attaches to a console. The stylus is inserted through the nostril to gently remodel the nasal tissue and improve airflow. VivAer does not involve any cutting, nasal tissue or bone removal, or use of an implant. Treatment with VivAer may be performed during an office visit with local anesthesia. The VivAer Stylus received CE Mark in 2016 and U.S. Food and Drug Administration 510(k) clearance in December 2017.

“Combined with the recently published VATRAC study, these findings further validate VivAer as a consistently effective solution supported by high quality evidence,” Aerin Medical Founder/Chief Medical Officer Scott Wolf stated. “With 20 peer-reviewed publications to date, the growing body of evidence continues to build confidence among physicians treating nasal valve dysfunction.”

Aerin Medical is a privately held, venture-backed company headquartered in Mountain View, Calif., that aims to expand access to relief for chronic ENT conditions. The company’s products, VivAer for nasal airway obstruction and RhinAer for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with technologies that are alternatives to invasive surgery. More than 150,000 patients have been treated with Aerin Medical products to date.