Aerin Medical announced today that it won FDA clearance for its RhinAer Stylus for nonsurgical treatment of chronic rhinitis.
RhinAer Stylus is designed to directly disrupt the signals that cause symptoms of nonallergic rhinitis through Aerin’s proprietary temperature-controlled technology that goes through the nasal airway to provide a therapeutic effect while minimizing risk to surrounding tissue.
Procedures using the RhinAer Stylus can be performed under a local anesthetic in an ENT physician’s office without any incisions and with minimal discomfort, according to a news release.
A pivotal clinical trial revealed that RhinAer Stylus demonstrated meaningful benefits to patients, as 96% of patients treated with the procedure reported an improvement in their rhinitis symptoms at six months. Symptoms also improved on average by 61%, with the most significant improvements coming for runny nose and post-nasal drip, which Aerin said are the most bothersome chronic rhinitis symptoms.
“The FDA clearance and launch of our second nonsurgical innovation for ENT physicians and patients is a significant milestone for Aerin,” Aerin president & CEO Fred Dinger said in the release. “More than 13,000 patients with nasal airway obstruction have now been treated with our first product, the VivAer Stylus with the Aerin console. With the addition of the RhinAer Stylus we now offer ENT physicians a platform solution that can be used to improve the lives of the millions of patients suffering from chronic rhinitis.”
