Biodegradable Intestinal Anastomosis Stent Stapler - No Residue in Body | China Suppliers & Factory

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Place of Origin Made in China
Brand Name Biodegradable intestinal anastomosis stent
Certification ISO13485
Model Number BIS22-H, BIS24-H, BIS26-H, BIS30-H, BIS34-H, BIS38-H

Product Detail

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 (FAQ)

How long does the intestinal anastomosis device take to disintegrate?

The product gradually disintegrates in the intestinal tract and is excreted from the body within 4 weeks (30 days) after surgery, leaving no residual foreign matter in the body.

Can the disintegration process of the device be monitored?

Yes. The device contains barium sulfate, which allows it to be developed and visualized under X-ray, enabling dynamic tracking of its disintegration process.

What are the main advantages of this anastomosis device?

It features a short anastomosis time, causes no damage to anastomotic submucosal vessels, reduces or avoids sutures, and effectively prevents complications such as anastomotic leakage.

What materials are used to make the device?

The device is composed of Polyglycolic Acid (PGA) and Barium Sulfate.

What are the recommended storage conditions?

It should be stored in a cool, dry, well-ventilated, and clean environment with a relative humidity of ≤ 80%, free of corrosive gases. Avoid prolonged exposure to elevated temperatures, and do not expose the device to environments exceeding 40°C.

Are there any contraindications for using this device?

Yes, the device is contraindicated in patients who require two or more intestinal anastomoses. Additionally, it must not be used by untrained or unskilled medical personnel.