EU gives Vent-Os Sinus Dilation System CE mark approval for sinusitis- SinuSys Corp
SinuSys Corp has announced receipt of the CE Mark for Vent-Os Sinus Dilation System, a low-pressure, self-expanding dilation device to treat frontal and sphenoid sinusitis, in addition to maxillary disease. 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.
The Vent-Os Sinus Dilation System received the CE Mark for its maxillary system in 2012. The FDA has also cleared the Vent-Os Sinus Dilation System in the U.S. for dilation of the maxillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures. The company will be filing for FDA clearance of its frontal and sphenoid devices upon completion of a multi-center clinical study.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
4 mins