Xiangtong® Fully Degradable Sinus Drug Stent System is a high-tech medical device independently developed by Puyi Bio, specially designed for patients with chronic rhinosinusitis (CRS) undergoing endoscopic sinus surgery (ESS).The product is implanted into the target site during and after surgery, which not only supports the separation of the wound and fixes the repaired mucosal flap, but also controls edema, prevents adhesions, maintains smooth drainage, and sustains the target site to fight against inflammation and promotes healing by means of slow-release hormones.
Subjects are 18-65 years of age, male or non-pregnant female. The subject/legally authorized representative understands the purpose and procedures of the trial and voluntarily signs an informed consent form.
Female subjects who are not breastfeeding at the time of the screening visit and who do not plan to breastfeed or become pregnant for up to one year after the starting point.
Subject has not participated in another clinical trial in the previous 3 months and agrees not to participate in another clinical trial until the endpoints of this trial have been met.
Subject has a known allergic reaction or contraindication to the device material and its degradation products (mometasone acid, levulinic acid, racemic polylactic acid, propyl lactate, lactic acid).
The subject is on long-term oral hormonal medications.
The subject is receiving immunosuppressive therapy or has a known immunosuppressive or autoimmune disease: the subject has diabetes mellitus.
The subject has or has had glaucoma or high intraocular pressure.