SinuSys Receives Health Canada and Australian TGA Approvals for AerOs Sinus DiIation System
1/7/2013 11:05:03 AM
PALO ALTO, Calif.--(BUSINESS WIRE)--SinuSys Corporation, an innovative sinus health company, today announced that the Company has received a Health Canada license and an Australian Therapeutic Goods Administration (TGA) Certificate for its AerOs™ Sinus Dilation System. The AerOs System is designed to treat chronic sinusitis by gently opening the sinus ostia, thereby restoring natural sinus drainage and ventilation using a simple, two-step interventional approach. The Company has also completed 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.