Biodegradable Intestinal Anastomosis Stent Stapler – No Body Residue from China Suppliers & Factory
PRODUCT FEATURES
Within 4 weeks after surgery, the product can gradually disintegrate in the intestinal tract and excrete from the body, without residual foreign matters.
It contains barium sulfate, which can be developed under X-ray, so its disintegration process could be dynamically tracked.
The suture should be reduced or even avoided, and the integrity of intestinal wall and blood supply would be ensured to the greatest extent, which is conducive to the healing of anastomotic stoma and preventing the occurrence of anastomotic leakage.
PRODUCT DESCRIPTION
| Product Use | Applicable for intestinal anastomosis. |
| Product Highlights | It is the first Intestinal anastomosis device in the world to effectively protect the blood supply of anastomotic stoma, facilitate physiological healing, and avoid the occurrence of anastomotic leakage. It can disintegrate and excrete from the body within 30 days. |
| Device Classification | [CN] Class II |
| Material | PGA, Barium Sulfate |
| Specification Description | Different specifications represent the maximum diameters of anastomotic stents of 22 mm, 24 mm……38 mm |
| Storage Conditions | The product shall be stored in an environment that is cool, dry, well-ventilated, clean with a relative humidity of not more than 80% and free of corrosive gases to avoid prolonged exposure to elevated temperatures. Do not expose the device to an environment over 40℃. |
PRODUCT SPECIFICATION
| Instructions | Disconnect the intestinal canal, use a professional intestinal diameter gauge to measure the inner diameter of intestinal canal, select a product of appropriate size to place in the intestinal lumen at the broken end, and finally perform suture. See the IFU for details. |
| Product advantages |
• Short anastomosis time, no damage to anastomotic submucosal vessels; • Within 4 weeks after surgery, the product can gradually disintegrate in the intestinal tract and excrete from the body, without residual foreign matters in the body; • The product contains barium sulfate, which can be developed under X-ray, so its disintegration process is allowed to be dynamically tracked; • It is easy to operate, conforms to physiology, disintegrates on time, and effectively avoids complications. |
| Product structure and composition | One-piece anastomosis stent |
| Precautions |
• The product is for single use; it is not designed to be used in case of damaged package. • The product must not be used by unskilled or untrained personnel. • It is contraindicated in patients requiring two or more intestinal anastomoses. |
| Shelf life | 2 years |
Frequently Asked Questions
What is the primary application of this intestinal anastomosis device?
The device is specifically designed and applicable for intestinal anastomosis, helping to connect disconnected intestinal canals during surgery.
How does the device disintegrate and leave the body?
Made of PGA and Barium Sulfate, the stent is designed to gradually disintegrate within the intestinal tract and excrete naturally from the body within 4 weeks (30 days) post-surgery, leaving no residual foreign materials.
Can the position of the stent be monitored after surgery?
Yes, the product contains barium sulfate, which is radiopaque. This allows medical teams to dynamically track the disintegration process under standard X-ray imaging.
What specs and sizes are available for this device?
The product comes in various specifications representing the maximum diameters of the anastomotic stents, ranging from 22 mm, 24 mm, up to 38 mm.
What are the recommended storage conditions?
It should be stored in a cool, dry, well-ventilated, and clean environment with a relative humidity of not more than 80%. It must be kept free of corrosive gases and protected from temperatures exceeding 40℃.
Are there any contraindications for using this product?
Yes, the device is contraindicated in patients who require two or more intestinal anastomoses. Additionally, it is for single use only and must only be operated by trained medical personnel.