Australia and Canada grant marketing go-ahead to AerOs sinus dilation system
SinuSys has received a Health Canada licence and an Australian Therapeutic Goods Administration certificate for its AerOs sinus dilation system. AerOs is designed to treat chronic sinusitis by gently opening the sinus ostia, thereby restoring natural sinus drainage and ventilation, using a two-step interventional approach. SinuSys has also completed patient enrolment in an initial Canadian clinical study and will continue patient follow-up as it awaits a response to its FDA 510(k) submission. The system received CE mark approval in September 2012 and is currently commercialising in Europe.
Unlike balloon dilation devices that use rapid, high-pressure inflation, the AerOs sinus dilation system is a low-pressure, self-expanding insert designed to gently and gradually open the maxillary ostia. AerOs incorporates the SinuSys' proprietary osmotic technology, which uses the body's natural fluids to expand the insert. After the ostia are opened, the insert is removed. The low-pressure, gradual expansion and simplicity of the device are designed to make it compatible for use in office-based procedures under local anaesthesia.