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Artegraft switches to copolyester for vascular graft tubes

Company transitions from cylindrical glass culture tubes for its collagen vascular grafts to a copolyester-based tube with a flat side, helping to prevent breakage and save money.

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Since incorporating in 1993, North Brunswick, NJ-based Artegraft Inc. has used glass tubes to ship its U.S. Food and Drug Administration-approved Class III natural collagen vascular grafts to hospitals, clinics, or hospital distributors. But occasional breakage during distribution and the desire to trim costs led the company to make a change this year to Eastman Chemical’s (www.eastman.com/medical) Eastar Copolyester MB002 resin. Eastman worked with O.Berk Co. (www.oberk.com) to make the conversion a successful one for Artegraft.

“The packaging expertise of O.Berk, coupled with the performance of Eastar Copolyester MB002, created the best possible solution for our conversion from glass to plastic,” says Laurence Potter, the company’s vice president of scientific affairs. “Now we have a more robust, stable, and safer package that does not compromise the surgical readiness or performance of our grafts.” He adds, “Secondary packaging costs can be decreased as well as transport, warehousing, and other expenses as a result of the switch to plastic.”

Besides the change in material, the new Artegraft tube incorporates an important functional change in its shape. Rather than stay with the cylindrical glass tube, the company opted to have the plastic tube molded (see story on page 25) with a flat side. “The glass version looked like a large test tube,” says Potter. “It was round, and if you put it on a table, it could roll off. So we designed it with a flat side. It provides another level of security from incurring damage once you lay it down within the operating suite.”

The diameter of the tube’s neck opening was increased for ease of use. A peel-away, heat-shrink, tamper-evident seal was added. “Now we have a more robust, stable, and safer package that does not compromise the surgical readiness or performance of our grafts,” says Potter.

Artegraft is not only the name of the company, but also the name of the company’s medical device, described on its Web site as “a biological fibrous matrix processed to enhance long-term patency [keeping the artery open] and provide a tightly woven, cross-linked conduit that is flexible and compliant.” The company says Artegraft was the first vascular graft approved by the FDA in 1970.

Artegraft “is a bovine collagen graft, made from a steer’s carotid artery,” says Potter. “We process the arteries through a variety of physical and chemical steps.” The company purchases the arteries from qualified processing plants, then processes them through a series of very specific physical and chemical steps. After chemical sterilization and packaging, the grafts are shipped to either medical sales distributors or directly to hospitals for surgical implantation in humans.

Potter says the vast majority of the grafts are used for AV (arterial venous) access in hemodialysis patients. After many needle sticks, a patient’s own blood vessels may no longer function properly. “When that happens, “ he explains, “a surgeon can insert [the Artegraft] into the specific physiological area that they want to use. This replacement graft can last for years, with proper care.”

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