Biodegradable Intestinal Anastomosis Stent Stapler without Residue - 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 & 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)

Q How does the intestinal anastomosis stent disintegrate after surgery?

The stent is designed to gradually disintegrate inside the intestinal tract within 4 weeks (30 days) post-operation and is naturally excreted from the body without leaving any residual foreign matter.

Q Can the stent position and disintegration be tracked post-operatively?

Yes. The device contains barium sulfate, making it visible under X-ray imaging so that medical professionals can dynamically monitor and track its disintegration progress.

Q What materials are used to manufacture this stent?

The product is made from medical-grade PGA (Polyglycolic Acid) and Barium Sulfate.

Q What size specifications are available for this device?

The stent comes in various outer diameter specifications to accommodate patient anatomy, with maximum diameters ranging from 22 mm, 24 mm, up to 38 mm.

Q What are the contraindications and precautions for this product?

The product is single-use only and must not be used if the packaging is damaged. It is contraindicated in patients requiring two or more intestinal anastomoses and must only be operated by trained personnel.

Q What are the storage requirements and shelf life?

The device has a shelf life of 2 years. It should be stored in a cool, dry, well-ventilated, clean environment with relative humidity under 80%, free from corrosive gases, and never exposed to temperatures above 40°C.