Sunnyvale, Calif.-based Aerin’s VivAer was studied in the VATRAC trial, with results published by the International Forum of Allergy and Rhinology.
According to a news release, the study confirmed the safety and efficacy of VivAer in treating NAO caused by nasal valve collapse (NVC). Those treated with VivAer showed significant improvement in nasal obstruction symptoms compared to the control group.
The multi-center, prospective, single-blinded, randomized, sham-controlled trial enrolled 117 patients with extreme or severe NAO with NVC as a primary or significant contributor to their symptoms. Patients were randomized to undergo in-office treatment with VivAer or an in-office sham procedure that replicated the treatment experience without delivery therapeutic radiofrequency energy.
VATRAC met its primary and secondary endpoints, as treated patients demonstrated a significantly superior response rate with 88.3% of the treatment group registering at least a 20% improvement in NOSE (Nasal Obstruction Symptom Evaluation) score against 42.5% in the control. Symptom reduction came in at 55.1% improvement in mean NOSE score versus 21.3% in the control.
Treated patients saw significant improvements in nasal congestion, nasal blockage, breathing and sleeping and breathing during exercise or exertion. Treatment was generally well-tolerated with no serious adverse events related to the procedure.
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 was included in MassDevice’s list of hottest startups in 2020.
“We believe that one reason NVC is commonly overlooked is the scarcity of non-invasive treatment options as an alternative to surgical repair,” Aerin Medical founder & CMO Dr. Scott Wolf said in the release. “To date, more than 30,000 people have been treated with VivAer, and the strong VATRAC trial results reflect our commitment to building a robust body of clinical evidence to support the safety and effectiveness of this non-invasive device.”