Safety and effectiveness of a 6-French MRI conditional pacemaker lead: The INGEVITY clinical investigation study results.

Background: The design of pacemaker leads has continued to evolve; ease of lead handling, improved electrical performance, and magnetic resonance imaging (MRI) conditional aspects have become more important, while safety remains critical. The INGEVITY™ family leads was designed to provide MRI conditional aspects, decreased diameter, and improved performance of pacemaker leads. The INGEVITY study is an investigational device exemption trial evaluating the acute and chronic safety and effectiveness of these leads.