Assurance of quality
Quality assurance and strict attention to process detail are the top priorities at Artegraft.
It begins with suppliers who know the demands of medical grade products. Every Bovine Carotid Artery we produce into a collagen vascular graft meets the most stringent specifications.
Our commitment to quality continues through each phase of the manufacturing process. Each production step is monitored, tested and documented by trained technicians in a ISO 7 cleanroom.
It all adds up to an implantable device in which surgeons can have complete confidence and patients can experience higher patency.
Our Quality Production Process includes:
- Incoming inspection of all arteries in our cleanroom to detect and reject anomalies
- Each selected artery is processed with USP purified water
- Suture ligation of side branch vessels is triple-knotted to withstand chemical processing and quality testing
- Chemical processing of the bovine carotid artery renders an acellular, nonantigenic collagen graft
- Dialdehyde starch process (artery tanning) crosslinks the collagen for strength and stability
- Testing at separate manometry pressures are conducted to assure strength and quality
- Each graft is measured for length and pressurized outer and corresponding inner diameters
- Every graft is sterilized in its container, shrink-wrapped in tamper-evident packaging, and prepared for shipment with 3 years expiration from date of manufacture
Artegraft. The Clinically Proven Choice.
Now you can use a clinically proven alternative to ePTFE grafts that offers surgical compliance and delivers significantly higher primary and assisted patency rates.