April 2, 2009
Originally Published MPMN April 2009
Synthetic Tissues Eliminate Use of Live Animals
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Synthetic tissue models offer a realistic testing alternative to the use of live animals and cadavers.
Centuries of scientific and medical strides since the Renaissance would have been impossible without the experimental use of human cadavers and live animals. But modern society has become increasingly uncomfortable with such practices, especially animal research. Animal Replacement Technologies offers a more humane alternative—synthetic human tissues and body parts.
While other companies offer synthetic tissue generally made of silicone rubber and plastic, Animal Replacement Technologies provides models composed primarily of water, fibers, and salts, which mimic the structural, chemical, and mechanical properties of living tissues, according to president and CTO Christopher Sakezles. With a product range that includes replaceable muscles, tendons, veins, arteries, and organs, the company, in Sakezles’s words, supplies a testing platform “that falls somewhere between live animals, people, and benchtop fixtures.”
Based on tests performed with live tissues, the models target at least three different properties to mimic real human tissues, including penetration resistance, abrasion resistance, tensile modulus, coefficient of dynamic friction, and tensile strength. In addition, some models are highly complex. For example, synthetic human artery models are complex composite constructions fabricated from three different synthetic tissues that imitate arterial intima, media, and adventitia.
“When these materials are assembled into an arterial construction, the resulting body part responds to stimulus—a medical device test—much like the real living thing,” Sakezles says. This feature enables medical device engineers to evaluate the effects of new and prototype devices in an environment that not only resembles end use but is also controllable and reproducible. “This capability is new and does not exist outside of our technology, even with live animals or human patients,” according to Sakezles.
In addition to their use in medical device testing, surgical simulation, medical training, medical device design verification, and validation studies, the models are employed by medical product designers, researchers, and educators to perform comparative benchmarking studies. Such tests allow developers to illustrate performance differences between prototype variants or prototypes and previously released devices. As benchmarking tools, the synthetic tissues support substantial equivalence claims to FDA.
The company has just released its third-generaton SynDaver brand of synthetic human arterial and venous models. At the same time, it is working on shoulder, knee, thigh, arm, heart, and trachea models. Sakezles comments, “We are building new body parts all the time.”
Animal Replacement Technologies, Bradenton, FL
Copyright ©2009 Medical Product Manufacturing News
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