Aerin Medical Announces FDA Clearance and U.S. Launch of Innovative Nonsurgical Procedure for Chronic Rhinitis
Posted on March 05, 2020 by Medtech[y] Staff
RhinAer™ Procedure Promises Lasting Relief for Millions of Americans Suffering from Common Chronic Condition
AUSTIN, Texas--(BUSINESS WIRE)--Aerin Medical Inc., a company focused on minimally invasive solutions for chronic nasal conditions, today announced U.S. Food and Drug Administration (FDA) clearance and U.S. launch of the company’s second product, the RhinAer™ Stylus, an innovative device for nonsurgical treatment of chronic rhinitis.
More than 30 million Americans suffer from nonallergic rhinitis.1 Patients with the condition suffer from runny nose, post-nasal drip, congestion, chronic cough, and other symptoms. For many patients, management with medications and sprays is inadequate. The RhinAer procedure provides lasting relief by directly disrupting the signals that cause symptoms. The procedure can be performed under a local anesthetic in an ENT physician’s office, with no incisions and minimal discomfort.
“Chronic rhinitis can significantly affect quality of life and impact daily activities,” said Adil A. Fatakia, M.D., a rhinologist at West Jefferson Medical Center in Marrerro, La. “The RhinAer procedure’s compelling clinical results, including its high responder rate, clean side effect profile and tolerability, make it a highly attractive option for my patients.”
Clinical results from the prospective, multi-center pivotal clinical trial of the RhinAer Stylus demonstrated meaningful benefits to patients. In the study, 96% of patients treated with the RhinAer procedure reported an improvement in their rhinitis symptoms at six months, with symptoms improving on average by 61%. The procedure was safe and generally well-tolerated. Notably, significant improvements were demonstrated for runny nose and post-nasal drip, 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,” said Fred Dinger, President and CEO. “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.”
Both procedures rely on Aerin’s proprietary temperature-controlled technology, which has been developed and optimized for the nasal airway to provide a precise therapeutic effect while minimizing risk to surrounding tissue.
About Aerin Medical
Aerin Medical is a privately held, venture-backed company, with offices in Austin, Texas and Sunnyvale, Calif. Aerin’s mission is to provide ENT physicians with minimally invasive procedures for the treatment of chronic nasal airway conditions. The company’s FDA-cleared products, the VivAer® Stylus for nasal airway obstruction and the RhinAer™ Stylus for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with a nonsurgical procedure under local anesthetic in their office.
1 Scarupa MD, Kaliner MA. Nonallergic rhinitis, with a focus on vasomotor rhinitis: clinical importance, differential diagnosis, and effective treatment recommendations. World Allergy Organ J. 2009; 2(3):20-25. doi:10.1097/WOX.0b013e3181990aac.
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