SinuSys has received CE mark approval for its low pressure, self-expanding AerOs Sinus Dilation system, designed to open the maxillary ostia and treat painful chronic sinusitis.
The AerOs device, which utilises the company’s proprietary osmotic technology, is a traumatic, tissue-sparing device that restores natural sinus drainage and ventilation using a simple two-step interventional approach, enabling clinicians to intervene at earlier stages of sinus disease.
University of British Columbia Sinus Centre director Dr Amin Javer said although the current clinical study is based in the operating room, the system is showing attributes that could make it ideal for treatment 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 said.
"Ultimately, this may allow us to treat sinus disease earlier in its progression to help a broader range of patients."
SinuSys CEO Thomas Schreck said the company is enthusiastic about making the AerOs System available to 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 said.
The AerOs system has been shipped to the UK for the first phase of the European commercialisation strategy, according to the company.
The company has completed an initial clinical study in Canada and is waiting for a response from the US Food and Drug Administration for its 510(k) submission.