SinuSys has received regulatory approvals from Health Canada and Australian Therapeutic Goods Administration (TGA) for its AerOs sinus dilation system, designed for the treatment of chronic sinusitis.
Designed for use in office-based procedures, the CE-marked AerOs system is a low pressure, self-expanding insert and features the company’s easy to use, atraumatic and tissue-sparing osmotic technology which 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 (openings that connect a sinus to the nasal cavity) to restore natural sinus drainage and ventilation.
The insert is removed, after the ostia are opened, according to the company.
SinuSys chief executive officer Thomas Schreck said the company is committed to bring 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 enrollment in our clinical study, demonstrate that we are moving forward aggressively in achieving key milestones as we prepare for a U.S. launch, pending our FDA 510(k) clearance," Schreck added.
In addition, the company has announced the completion of patient enrollment in its initial Canadian clinical study and will continue patient follow-up, as it awaits a response to its FDA 510(k) submission.