Sinus health company SinuSys has obtained regulatory approvals from Health Canada and Australian Therapeutic Goods Administration (TGA) for its sinus dilation system, designed for the treatment of chronic sinusitis.
The CE-marked AerOs system, which is a low-pressure, self-expanding insert, features the company’s atraumatic, tissue-sparing osmotic technology that enables clinicians to intervene at earlier stages of sinus disease.
The technology uses the body’s natural fluids to expand the insert and open the maxillary ostia to restore natural sinus drainage and ventilation.
The insert is removed after the ostia are opened, according to the company.
The device can be deployed in an office setting due to the low-pressure, gradual expansion and simplicity of use.
SinuSys chief executive officer Thomas Schreck said the company is committed to bringing a simpler and gentler procedure to otolaryngologists to enable them to intervene earlier in the disease continuum, which has the potential to dramatically improve patients’ quality of life.
"Obtaining regulatory approvals in Canada, Australia and Europe, and completing enrolment in our clinical study, demonstrate that we are moving forward aggressively in achieving key milestones as we prepare for a US launch, pending our FDA 510(k) clearance,"
The company has also announced the completion of patient enrolment in its initial Canadian clinical study and will continue patient follow-up as it awaits a response to its FDA 510(k) submission.