Optimizing pacing lead design: redesign of the tined lead

Technical data derived from experimental and clinical experience in the field of lead/catheter implants formed the basis for developing a set of technical design criteria for pacing leads. Four related levels of technical data were identified: Basic lead components, mode of installation, application site, and mode of use. When the technical data were evaluated, a joint goal between the medical and engineering community evolved--namely, to reduce the total transvenous lead-related reoperation rate (both acute and chronic) from 20-25 percent to below 5 percent. As a result, a new family of leads designed specifically to meet the less than or equal to 5 percent reoperation rate is now available; the first leads introduced are a radical redesign of an earlier tined lead. The development process and results, both experimental and clinical (N greater than 1,005), demonstrate the potential of careful technical definition and communication of biomedical problems between engineering and medical personnel.