Michael Barbella, Managing Editor09.18.23
Aerin Medical Inc. is sharing positive two-year follow-up data from the AERWAY trial for patients with severe or extreme nasal airway obstruction (NAO) due to nasal valve collapse (NVC). Results featured in Laryngoscope Investigative Otolaryngology showed a significant and long-term improvement in NAO symptom burden.
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. Key findings include:
Earlier this year the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) issued a position statement noting that NVC 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 NVC 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,” Aerin Medical CEO Matt Brokaw said. “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.”
The most common symptoms of NAO include nasal congestion or stuffiness, trouble breathing through the nose, trouble sleeping, and difficulty breathing well during exercise or exertion, and these symptoms can take a heavy toll on daily life. NVC contributes to nasal obstruction for 73% of highly symptomatic individuals,1 but is often under-diagnosed and left untreated. This can have a significant impact on a person’s quality of life, as the nasal valve is the narrowest part of the nasal airway and even small obstructions can create an exponential reduction in airflow. VivAer offers ENT physicians a unique, non-invasive and office-friendly option that durably remodels tissue in the nasal valve to address NAO in appropriate 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 via the nostril to gently remodel the nasal tissue and improve airflow. VivAer does not involve any cutting, removal of nasal tissue or bone, or the use of an implant. Treatment with VivAer may be performed during an office visit with local anesthesia. Patients typically experience little discomfort with minimal to no downtime and are often able to return to normal activities following treatment. The VivAer Stylus received CE Mark in 2016 and U.S. Food and Drug Administration 510(k) clearance in December 2017.
Aerin Medical is a privately held, venture-backed company, with U.S. offices in California and Texas. Aerin’s mission is to provide ENT physicians with non-invasive solutions for the treatment of chronic nasal 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 in-office procedures performed with local anesthetic. More than 75,000 patients have been treated with Aerin Medical products to date.
Reference:
1 Clark, David; Del Signore, Anthony; Raithatha, Roheen; Senior, Brent; 2018. Nasal airway obstruction: Prevalence and anatomic contributors; 2018 ENT Ear Nose & Throat Journal; 97(6).
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. Key findings include:
- Statistically significant and sustained improvement in symptom burden was achieved in all subpopulations including NVC patients with untreated septal deviations and either static or dynamic NVC
- Ninety percent 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
Earlier this year the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) issued a position statement noting that NVC 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 NVC 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,” Aerin Medical CEO Matt Brokaw said. “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.”
The most common symptoms of NAO include nasal congestion or stuffiness, trouble breathing through the nose, trouble sleeping, and difficulty breathing well during exercise or exertion, and these symptoms can take a heavy toll on daily life. NVC contributes to nasal obstruction for 73% of highly symptomatic individuals,1 but is often under-diagnosed and left untreated. This can have a significant impact on a person’s quality of life, as the nasal valve is the narrowest part of the nasal airway and even small obstructions can create an exponential reduction in airflow. VivAer offers ENT physicians a unique, non-invasive and office-friendly option that durably remodels tissue in the nasal valve to address NAO in appropriate 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 via the nostril to gently remodel the nasal tissue and improve airflow. VivAer does not involve any cutting, removal of nasal tissue or bone, or the use of an implant. Treatment with VivAer may be performed during an office visit with local anesthesia. Patients typically experience little discomfort with minimal to no downtime and are often able to return to normal activities following treatment. The VivAer Stylus received CE Mark in 2016 and U.S. Food and Drug Administration 510(k) clearance in December 2017.
Aerin Medical is a privately held, venture-backed company, with U.S. offices in California and Texas. Aerin’s mission is to provide ENT physicians with non-invasive solutions for the treatment of chronic nasal 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 in-office procedures performed with local anesthetic. More than 75,000 patients have been treated with Aerin Medical products to date.
Reference:
1 Clark, David; Del Signore, Anthony; Raithatha, Roheen; Senior, Brent; 2018. Nasal airway obstruction: Prevalence and anatomic contributors; 2018 ENT Ear Nose & Throat Journal; 97(6).
