Q: Is Artegraft® FDA approved?
A: Yes, Artegraft® was approved in 1970.
Food and Drug Administration
- Trade Name
- ARTEGRAFT® AND REINFORCED ARTEGRAFT
- Artegraft, Inc.
- PMA Number
- Date Received
- Decision Date
- Artegraft, Inc.
206 North Center Drive
North Brunswick, NJ 08902
- Registration Number
- Artegraft, Inc.
- Owner/Operator Number
- Official Correspondent
- Joseph A. Ciccone
Phone: (732) 422-8333
- Product Code
- Classification Name
- Tissue graft of 6 mm or greater; Tissue graft of less than 6 mm.
To view current FDA registration status and information, please visit https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm and enter 2247686 in box labeled “Registration or FEI Number”.
Artegraft® Collagen Vascular Graft™ (Bovine Carotid Artery Graft™) and Joint Commission (JC) Tissue Regulations 2015
Artegraft, Inc. is regulated and registered as a U.S. Food and Drug Administration (FDA) medical device manufacturer (Establishment Registration 2247686). Numerous federal regulations apply to Artegraft, including Quality System (QS) Regulations/Good Manufacturing Practices (GMP) – 21 CFR Part 820. The Artegraft Collagen Vascular Graft is approved by FDA via PMA N16837 and consists of a modified bovine-sourced carotid artery which has been subjected to a series of highly specific chemical and manual processes designed to de-cellularize, or render “acellular”, the artery material in order for the device to be suitable for human implantation as a vascular graft.
The Artegraft Collagen Vascular Graft device is considered an acellular, non-antigenic, collagen matrix (heterograft) of animal origin. As such, all Artegraft Collagen Vascular Grafts are exempt from U.S. FDA Regulation 21 CFR Parts 1270-1271 Human Cells, Tissues and Cellular and Tissue Based Products. 21 CFR 1271.3(d)(6) specifically excludes cells, tissues, and organs derived from animals other than humans.
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 incremental changes instituted over subsequent years. Current JC standards and specific tissue transplant requirements apply to autologous tissue only.
If further clarification is required regarding this device, you can contact directly the Joint Commission Standards Interpretation Group at (630) 792-5900.
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, some examples might include Cefazolin or Vancomycin.
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.
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 vascular 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: 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, or the information can be completed online by clicking on “Implant Registration” within the website header.
Q: How should the preservative solution in the bottle be disposed?
A: Adhere to your hospital’s biohazardous waste protocol.
Q: Does the Artegraft contain Latex Rubber?
A: The product is Not Made with Natural Rubber Latex
Q: Can heparin be used with Artegraft?
A: Patients subjected to heparin anticoagulant rinse and flush should be confirmed to be heparin-induced thrombocytopenia (HIT) free, and of heparin associated allergic reactions. Please see PRECAUTIONS within the product Instructions for Use (IFU).
Q: How soon can Artegraft be accessed?
A: A minimum of ten days should be allowed after implantation before puncturing the graft with needles for hemodialysis.
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 the most recent K-DOQI Guidelines 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