The U.S. Food and Drug Administration (FDA) has given clearance for a full family of sinus dilation devices, adding two new devices from SinuSys Corporation that will expand the company’s portfolio of low-pressure, self-expanding dilation devices to enable dilation of the frontal and sphenoid sinuses to address sinusitis symptoms.
The addition of the new devices complement the previously FDA cleared Vent-Os device for maxillary sinus dilation. The new devices will be immediately available in the U.S.
In the most recent prospective, multi-center clinical study, the Vent-Os Sinus Dilation System demonstrated sustained patency rates out to three months comparable to, or better than, other available sinus dilation techniques.
Previously, in a prospective, multi-center clinical study, the Vent-Os Sinus Dilation System demonstrated the ability to maintain patent maxillary sinus ostia at 12 months in 93 percent of treated ostia.
Unlike balloon dilation devices that use rapid, high-pressure inflation, the Vent-Os Sinus Dilation System is a small, low-pressure, self-expanding insert designed to gently and gradually open the sinus ostia. The Vent-Os System incorporates SinuSys Corporation’s proprietary osmotic technology, which utilizes the body’s natural mucosal fluids to expand the device before removal. In an office setting, patients are comfortably relocated to the waiting room between placement and removal of the device.
“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,” said SinuSys Chief Executive Officer Tom Schreck.