[Warning]

l   The BISORB^® Drug-Eluting Sinus Absorbable Stent System has been sterilized before exiting the factory. This product is for single-use only, do not sterilize and reuse it.

l   Please carefully inspect the product packaging before use. Do not use products with unsealed or damaged packaging. The package contains a desiccant and an oxygen absorber. Do not consume. Do not use if the package of the desiccant and oxygen absorber is damaged.

l   Before using, please check the shelf life of the product carefully and do not use the expired product.

l   The surgical procedure should be completed by a qualified professional physician trained in the implantation of this product.

l   The risk of applying this device is the same as that of general intranasal device implantation, including implant displacement, dislodgement of the implant or its degraded fragments from the nostril or swallowing of the implant or its degraded fragments into the digestive system.

l   Please read the product instructions for use carefully before using the product. Attention should be paid to all warnings and precautions on the instructions for use; otherwise, accidents may occur.

[Contraindications]

The use of BISORB ^® stent system is strictly prohibited for the following types of patients:

l  Those who are allergic to mometasone furoate and its derivatives;

l  Those who are allergic to lactide-glycolide copolymers and their degradation products.

[Precautions]

l  General Precautions

Only qualified physicians who have received BISORB ^® stent implantation training can perform implantation surgery;

No studies have been conducted on pregnant women; for pregnant and breastfeeding women, this product can only be used if the benefits to the mother, fetus or infant after using this product outweigh the possible harm;

The doctor can decide the oral and topical medications at his/her own discretion based on the patient’s condition.

l  Precautions for Stent Implantation

1）   When the stent is pre-placed in the sheath of the delivery system, it should not be compressed more than 2 times;

2）   A single delivery system cannot be pushed more than 2 times;

3）   A single delivery system corresponds to a single sinus stent. It cannot be used for other stents of other specifications or the same specifications; it must not be re-sterilized for use;

4）   When adjusting the position of the stent after implantation, avoid excessive pulling to prevent the cracking or folding of the stent intersection;

5）   The time from crimping the stent to releasing the stent to the predetermined site for clinical use is no more than 3 minutes.

[Potential Risks]

1） Potential risks caused by sinus stent implantation

 · Expected external stent displacement

 · Dislodgement of the stent or its degraded fragments from the nasal cavity

· Swallowing of the stent or its degraded fragments into the digestive system

2） Drug-induced potential risks

· Allergic nasal reaction

· Allergic reaction

· Intranasal hemorrhage

· Epistaxis

· Localized nasal or respiratory tract (bacterial, fungal or viral) infection

· Dry nose

· Burning nasal sensation

· Increased intraocular pressure/glaucoma

· Cataract

· Headache

· Sore throat

· Vomiting

· Myalgia