Acute Care Questions
Q: Is Artegraft FDA approved?
Yes, Artegraft was approved in 1970.
Food and Drug Administration
ARTEGRAFT™ AND REINFORCED ARTEGRAFT
||tissue graft of 6mm and greater20
||tissue graft of 6 mm and greater
|Product Code LXA
||[ Registered Establishments with LXA21]
|Expedited Review Granted?
||S00122 S00323 S00424 S00525 S00626 S00727 S00828
Q: What are the indications for use?
A: Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft. The use of the Artegraft for femoropopliteal bypass should be reserved for those patients where the autologous saphenous vein is absent or inadequate. It is also not recommended for reconstruction across the knee joint. However, in the absence of other viable alternatives, the surgeon may well find the benefit-to-risk ratio warrants its use as an attempted limb salvage procedure.
Q: What is the primary contraindication?
A: Artegraft should not be used in venous or low pressure systems.
Q: What antibiotic is most commonly used in a prophylactic manner?
A: As with many prosthetic implants, Cefazolin or Vancomycin are commonly used.
Q: Is Artegraft human tissue?
A: No. The graft is made from the carotid artery of food source cattle. Many other implantable medical devices come from bovine sources. All material is certified by our suppliers to be BSE-free.
Statement: Artegraft® Bovine Collagen Graft and Tissue Regulations
Artegraft Inc. is an FDA registered medical device manufacturer regulated under Quality System Regulations (QSR) 21 CFR 820. Our Establishment Registration number is 2247686. The Artegraft® Collagen Vascular Graft is approved by FDA via PMA N16837, and consists of a modified bovine carotid artery which has been subjected to highly specific chemical and manual processes to de-cellulaze, or render acellular, the material in order for the device to be suitable for human implantation as a vascular graft.
The Artegraft is considered an acellular, collagen matrix (heterograft). As such, all Artegraft Vascular Grafts are exempt from regulation (21 CFR parts 1270-1271) HUMAN CELLS, TISSUES AND CELLULAR AND TISSUE BASED PRODUCTS per 21
On July 1, 2005, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO, now simply Joint Commission, JC) tissue standards went into effect for any JC accredited organization that stores or implants allograft or human tissue. The standards have had changed instituted for subsequent years. As an acellular collagen matrix derived from bovine-sourced vascular carotid arteries, Artegraft products are also exempt from these standards. Artegraft collagen vascular grafts are exempt from JC requirements per rules published in the Comprehensive Accreditation manual for Hospitals: The official Handbook, Refreshed Core, January 2010, Transplant Safety, page TS-7, Introduction to Standards TS.03.01.01, TS.03.02.01 and TS.03.03.01 states as follows: "The following standards apply to hospitals that store or issue tissue...Collagen and tissue products derived from plastics and polymers are not evaluated under these standards," thus JC tissue storage and tracking regulations do not apply to Artegraft products.
For further clarification, the following is an excerpt from the Joint Commission website:
Hospital Tissue - Standards Applicability - March 23, 2011
Q: What tissue products are surveyed under the standards in the Transplant Safety chapter?
A: The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells), e.g. acellular dermal matrix. Products that are derived from human or non-human tissue and cellular materials, but which are rendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Please check the manufacturer's package insert for the product's composition. A list of common tissue and cell products is also included in the introduction to the standards in the standards manual. The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products. These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
Artegraft, Inc. is not registered with the U.S. Food and Drug Administration (FDA) as a tissue establishment, rather as stated above, the company is registered with FDA as a medical device manufacturer. As such, no state tissue license is required or available. 2011 changes to the Tissue Standards provide that hospitals now do not have to check FDA registration for suppliers from which they purchase products considered tissue by JC but medical devices by FDA.
If further clarification is required, you can contact directly the Joint Commission Standards Interpretation Group at:
JC Standards Interpretation Group For Tissue Standards Interpretaion 630-792-5900
Q: What is the shelf life?
A: Three years from the date of manufacture. The expiration date is clearly shown on the package label.
Q: What suture should be used?
A: The most commonly used is 5-0 or 6-0 polypropylene in continuous suture, according to the surgeon's preference. Anastomotic clips have also been effectively utilized.
Q: Is there any reaction after implant?
A: While any foreign material may cause a reaction, Artegraft is tested as non-antigenic, packaged sterile in its container.
Q: What manner is commonly used to thrombectomize Artegraft?
A: Thrombosed grafts can be salvaged by conventional means such a thrombectomy and patch angioplasty, or percutaneous lysis and balloon angioplasty.
Q: What tunneler can be used?
A: Most common stainless steel tunnelers can be used with Artegraft, e.g., bullet tip Kelly-Wick. It is not recommended that Artegraft be inserted and pulled through the lumen of a tunneling device.
Q: How is steal syndrome ameliorated?
A: Artegraft may be manually tapered during surgery to the appropriate native vessel millimeter size, and the arterial anastomosis can be easily narrowed with a running suture.
Q: Does Artegraft contain latex?
A: No. It is latex free.
Q: Why must the graft be soaked and flushed with sterile saline?
A: Artegraft is stored and preserved in alcohol, thus the graft must be thoroughly rinsed with sterile saline and/or heparinized saline prior to implant. Read the Preparation For Implant guidelines attached to the package.
Q: If an Artegraft bottle is open and not used immediately, can it be used later?
A: No. Sterility will have been compromised. Once the package seal is broken, the graft should be used immediately. Any left-over material should be discarded.
Q: What is the reimbursement coding for Artegraft?
A: CPT is 36830, APC is 0088, HCPCS code is C1768. A patient implant card is included with each product and should be filled out and returned to Artegraft.
Q: How should the preservative solution in the bottle be disposed?
A: Adhere to your hospital’s biohazardous waste protocol.
Q: How soon can Artegraft be accessed?
A: The approved time is a minimum of 10 days after implant, but many dialysis units wait two to four weeks so the graft has a chance to incorporate in the subcutaneous tissue.
Q: How should the graft be cannulated with the fistula needle?
A: Think of Artegraft just as you would a fistula. Its collagen matrix is like an artery (or vein), thus it should be accessed in the same fashion as a native fistula, at a 25-30° angle. Do not push the needle too hard as it may exit the graft’s back wall and cause a hematoma.
Q: Can a clamp or blood pressure cuff be used on Artegraft?
A: No, as this may contribute to thrombosis.
Q: How is the Artegraft best cared for?
A: The graft is literally your "lifeline" and the highest degree of personal compliance and hygiene possible will help it to function properly. Refer to K-DOQI Guideline 14 for more information.
Q: What should the dialysis/caregiver know about Artegraft?
A: Inform them that you have a natural collagen graft; access the graft similar to a native fistula; and rotate the needle site each dialysis treatment so the graft lasts longer.
LISTED BELOW ARE SOME SIGNS TO WATCH FOR – ANYTHING YOU CONSIDER UNUSUAL SHOULD BE IMMEDIATELY DISCUSSED WITH THE NURSE OR DOCTOR:
- Bleeding that won’t stop
- Shortness of breath
- Loss of feeling in your hand/fingers
- Swelling of the arm or hand on the graft side
- "Ballooning" of the graft
- Redness or tenderness of the area
- Fever and/or chills
- Nausea or vomiting