Aerin Medical’s Next-Gen RhinAer Stylus Gains FDA Nod

Aerin Medical has gained U.S. Food and Drug Administration (FDA) 510(k) clearance and launched its next-generation RhinAer stylus.
 
RhinAer is a non-invasive, temperature-controlled radiofrequency (RF) device to treat the causes of rhinorrhea (runny nose), post-nasal drip, and congestion linked to chronic rhinitis in one session.
 
The new RhinAer’s design provides improved visualization, easier access, and tissue apposition—particularly for narrow nasal airway, according to the company.
 
“The new RhinAer stylus gives me confidence that I can access and treat the posterior nasal nerve area more effectively,” Dr. Randall Ow, otolaryngologist at Sutter Health in Sacramento and the first physician in the world to use the device on a patient, told the press. “This newer generation RhinAer allows me to confidently treat multiple target areas, in the office setting, even in very challenging anatomy.”
 
RhinAer’s new lower-profile stylus was modified with a slimmer shaft and tip. The tip also tilts backward 10 degrees and the shaft is more malleable.
 
“As a company that is committed to innovation, Aerin Medical relentlessly strives to meet the needs of physicians and their patients,” said Matt Brokaw, CEO of Aerin Medical. “We listened closely to the otolaryngology community in developing the new RhinAer. Based upon our discussions, rigorous testing and physician feedback, we are confident that the next-generation RhinAer stylus enhancements will be well-received.”
 
RhinAer has been clinically proven in multiple studies to durably treat chronic rhinitis symptoms. A recent long-term clinical study of RhinAer showed 88.2% of patients positively responded to treatment at 24 months, defined as a ≥30% improvement in chronic rhinitis symptoms compared to baseline.