S.T. Stent receives FDA clearance
S.T. Stent announced that it received regulatory clearance from the U.S. FDA for its composite sinus stent.
Millions of people worldwide suffer from chronic sinusitis, an inflammation of the sinuses caused by infection or allergy and characterized by facial pain and pressure, nasal congestion, and headaches. When drug treatments are ineffective, Functional Endoscopic Sinus Surgery (FESS) is often performed to increase airflow within the nose and sinuses, improve drainage, and remove diseased tissue. However, up to 30% of these surgeries are unsuccessful due to scarring and recurrent inflammation that closes the nasal openings and requires revision surgery.
S.T. Stent’s removable stent, which is placed after FESS surgery, keeps the sinus cavity open for up to 28 days, long enough for the sinus tissue to heal. Stent removal is a minimally invasive procedure performed in the doctor’s office, without the need for anesthesia. The stent improves patient outcomes and reduces the probability of revision surgeries. In addition to chronic sinusitis, the stent can be used for nose job failures, chronic allergic rhinitis, and as a direct stenting alternative to sinuplasty.
“Following excellent results in our clinical trials performed on 30 patients earlier in 2017, we are extremely pleased to have received regulatory clearance from the FDA. This is a significant milestone for S.T. Stent, which will allow us to market our product in the United States,” remarked Joseph Flomenbilt, Ph.D., company CEO.