SinuSys said today it won FDA 510(k) clearance for 2 new Vent-Os sinus dilation devices designed for treating sinusitis symptoms.
The Palo Alto, Calif.-based company said it won clearance for 2 new devices which allow dilation of the frontal and sphenoid sinuses.
“The Vent-Os system is easy to deploy and enables physicians to bring the benefits of minimally invasive sinus dilation to their patients in an office procedure that is highly tolerable under topical or local anesthesia. By adding devices for treatment of the frontal and sphenoid sinuses, an expanded group of patients will be able to benefit from this simple, gentle sinus dilation procedure that I plan to use for both early-stage chronic sinusitis patients who have failed medical therapy and patients suffering from recurrent acute sinusitis,” Dr. Ed Hepworth of the Denver Sinus Institute said in a press release.
The company touted its most recent prospective multi-center trial, which reported that its Vent-Os sinus dilation system demonstrated sustained patency rates better than or equal to other available sinus dilation techniques at 3 months.
“Our proprietary low-pressure, self-expanding technology has the potential for broad application in sinus disease, and we are pleased that we can now provide ENTs and their patients with effective, long term solutions for several sinus anatomies. With FDA clearance, we are focused on immediately bringing these broader benefits to physicians in the U.S., expanding utilization of our technology, and developing innovative, new therapies to address sinus disease that affects so many millions of people worldwide,” CEO Tom Schreck said in prepared remarks.