SinuSys Corp. has announced it has completed its FDA 510(k) submission for a new sinus dilation system, according to a news release.
The AerOs sinus dilation system is designed to open the sinus ostia, helping restore natural sinus drainage and ventilation using a two-step interventional approach, according to the company.
SinuSys also announced it has also received the CE Mark for the AerOs system and shipped devices to the United Kingdom.
"Our CE Mark demonstrates the significant momentum we are generating leading toward a global presence," said SinuSys CEO Thomas Schreck, in the release. "We are enthusiastic about commercialization of the AerOs System for otolaryngologists and their sinusitis patients in Europe. At the same time, we plan to expand application of our technology into other devices that can address the multi-factorial nature of sinus disease, including devices for the frontal and sphenoid sinuses."
SinuSys Corp. is headquartered in Palo Alto, Calif.
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