SinuSys has obtained CE mark for its AerOs Sinus Dilation system, designed to open the maxillary ostia (openings that connect a sinus to the nasal cavity) and treat painful chronic sinusitis.
The low pressure, self-expanding AerOs device utilizes the comany’s proprietary osmotic technology to restore natural sinus drainage and ventilation.
University of British Columbia Sinus Centre director Dr. Amin Javer said in the current clinical study of patients treated in the operating room, the AerOs System has demonstrated that the device is a correct tool of choice to treat chronic sinusitis in an office setting.
"The device is simple to use and its low-pressure expansion should be well-tolerated by patients under local anesthesia," Javer added.
"Ultimately, this may allow us to treat sinus disease earlier in its progression to help a broader range of patients."
SinuSys chief executive officer Thomas Schreck said the company is enthusiastic about commercialisation 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," Schreck added.
The company said it has completed the initial clinical study in Canada and is awaiting a response from the US Food and Drug Administration for 510(k) submission.