ANIMALS IN RESEARCH POLICY

As a manufacturer of medical devices, Medtronic is required to demonstrate the safety and efficacy of its products to the satisfaction of the U.S. Food and Drug Administration (FDA) and to other regulatory authorities worldwide. In many cases, these authorities prescribe animal research as the only means to provide information they accept as valid. As a result, Medtronic scientists involve animals in research when necessary to help us better understand the use of medical technology to treat certain chronic diseases.

When required to use animals in its research efforts, Medtronic is focused on:

• using the smallest, reasonable number of animals for a study;
• carefully designing and researching study protocols to avoid unnecessary tests and duplication of data; and
• exploring and implementing alternatives to animal research.

Medtronic is committed to the highest standards of respectful, humane care of animals. Research by the company conforms to, or exceeds, standards and principles set by federal authorities and is overseen by the U.S. Department of Agriculture (USDA) and Medtronic’s staff of licensed veterinarians. As required by the regulations, Medtronic established an ethics committee that reviews research protocols and conducts regular facility inspections. Our research environment is also accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC), which regularly conducts on-site reviews of our practices and protocols. We also hold vendors and service providers to the same ethical and quality standards we apply to ourselves.

Finding alternatives to animal research when possible has been our practice for more than 30 years, and we continue to focus on finding ways to replace and reduce the use of animals with technology advances such as computer modeling, animation and simulation. Medtronic pioneered the use of computer models and simulators to test the detailed algorithms programmed into cardiovascular devices. We also use a series of computer simulation systems and non-animal models for training physicians on the placement and handling of new cardiac pacing leads and delivery catheters.