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Biodegradable Intestinal Bypass Stents - China Factory Suppliers to Avoid Secondary Surgery
PRODUCT FEATURES
1. It takes a short time for the anastomosis, technical methods are easy to master, and iterate products in the future are suitable for laparoscopic implementation;
2. Avoiding the anal fistula indwelled and the secondary surgery;
3. The physiological and psychological trauma of the patients is significantly reduced.
PRODUCT DESCRIPTION
Product Use
Applicable for bowel bypass surgery.
Product Highlights
It is the first medical device in the world to protect the anastomotic stoma of low rectal cancer from stoma and reposition surgery. 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
Create an ileal incision 10 cm-15 cm from the ileocecal junction, place a product with appropriate size, and finally perform suture. Then place a drainage tube in the incision 10 cm proximal to the anastomosis. See the IFU for details.
Product advantages
- Effective prevention of anastomotic leakage;
- It can avoid artificial anus indwelling and secondary operation;
- Short treatment duration (2-4 weeks)
- Within 4 weeks after surgery, the product can gradually disintegrate in the intestinal tract and excrete from the body, without residual foreign matters;
- The product contains barium sulfate, which can be developed under X-ray, so its disintegration process is allowed to be dynamically tracked;
- The physical and psychological trauma of the patients is significantly reduced.
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 the Biodegradable Intestinal Bypass Stent?
The product is applicable for bowel bypass surgery. It is specifically designed to protect the anastomotic stoma of low rectal cancer from stoma and reposition surgery.
How long does it take for the stent to disintegrate and excrete from the body?
The stent is designed to gradually disintegrate in the intestinal tract and excrete from the body within 30 days (typically 2-4 weeks) post-surgery, leaving no residual foreign matters.
Can the disintegration process of the stent be monitored?
Yes. The product contains Barium Sulfate, which allows it to be developed under X-ray. This enables clinicians to dynamically track its disintegration process.
What are the main advantages of using this biodegradable stent?
Key advantages include effective prevention of anastomotic leakage, avoiding artificial anus indwelling and secondary operations, short treatment duration, and a significant reduction in physiological and psychological trauma for patients.
What are the storage conditions and shelf life requirements?
The product has a shelf life of 2 years. It must be stored in a cool, dry, well-ventilated, and clean environment with a relative humidity of not more than 80%, free of corrosive gases, and never exposed to temperatures exceeding 40℃.
Are there any contraindications or usage limitations?
Yes. The product is strictly for single use and must not be used if the packaging is damaged. It should only be handled by trained, skilled personnel, and is contraindicated in patients requiring two or more intestinal anastomoses.