Originally Published MDDI January 2004

R&D DIGEST

Erik Swain

A synthetic vascular sealant could prevent leakage.

Clinical trials have begun for a new kind of synthetic vascular sealant designed to prevent the surfaces of veins, arteries, and artificial grafts from leaking after surgery. 

Unlike existing products, the sealant is synthetic, meaning there is no risk of the infection transmission or immune response disorders that have been associated with both human- and animal-based blood products, according to its manufacturer, Closure Medical Corp. (Raleigh, NC).
Another quality differentiating the sealant, which does not yet have a name, is that it is transparent, which allows physicians to confirm that the seal has been completed.
 
Initial clinical studies of the sealant will focus on its use in peripheral vascular procedures such as reconstructive grafts and artificial grafts for dialysis access. It also will be evaluated for other applications, says Daniel A. Pelak, Closure's president and CEO.

“Next year, we hope to file an IDE for neurological procedures,” he says. “There is no good (sealant) product on the market for that right now. And by the end of 2004, we hope to file one for lung procedures.” Pelak adds that other advantages of a synthetic sealant include better adhesive capabilities than existing products, ease of use, and cost. “It does not require mixing, nor does it require a lot of special storage,” he says. “All you have to do is open a blister pack.” 

The basis for the product is Closure's proprietary 2-octyl cyanoacrylate technology. According to the company, cyanoacrylates are reactive monomer liquids that become polymer films when they react to moisture or certain chemicals. The monomer liquid polymerizes directly on the surface it is applied to, creating a high-quality film. By contrast, many other adhesives begin as liquid polymers and “dry out” when applied to a surface, making them less robust. In addition, 2-octyl cyanoacrylate has a long alkyl chain length that enables films formed from it to be biocompatible, flexible, and high in microbial barrier properties. 

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