IMPLANTABLE SYSTEMS PERFORMANCE REGISTRY (ISPR) A MEDICAL DEVICE AND PATIENT REGISTRY

Author(s)

Stoker V, Weaver T, Hargens L Medtronic, Minneapolis, MN, USA

OBJECTIVES: ISPR is a prospective, post-market, surveillance registry designed to monitor implantable neurological devices. For each patient enrolled demographics, implant and practice techniques, and patient reported outcomes are collected and analyzed to elucidate the etiology of device complications. The goal is to expand registry centers, based on pre-defined criteria, and generate data representative of the medical community and its patients. This registry is a foundation and electronic platform for outcome registry projects. METHODS: Single and multi-physician centers follow standard clinical practice and a common registry protocol. Center activation includes software and protocol training and IRB approval at each center. Information registered with the U.S Food and Drug and Administration (FDA) mandated Device Registration System (DRS) pre-populates the registry avoiding redundant data submission, while centers provide additional information through electronic data capture. Active surveillance occurs at 6-month intervals with data reporting required for device or patient events. These event data are electronically communicated to fulfill FDA-mandated event reporting regulations, thus creating efficiencies for the sponsor and physician. The potential of selection bias in ISPR is minimized through 100% eligibility of all implanted devices at each center. The approach for ISPR center expansion is based on geographic, specialty, and practice distribution to achieve a representative sampling of real world experience, effectiveness and safety. A multidisciplinary advisory board oversees reporting with the goal of peer reviewed scientific presentation and publication. RESULTS Annual aggregate and center specific reports are generated including descriptive statistics and survival curves. CONCLSUIONS: The data collected in this registry are representative of the medical community with generalizability to a broader patient population. ISPR results may illuminate methods to improve therapy and guide development, provide insight into the etiology of events through evaluation beyond what is possible with passive surveillance, and generate best practices associated with reduced events and improved outcomes.

Conference/Value in Health Info

2005-11, ISPOR Europe 2005, Florence, Italy

Value in Health, Vol. 8, No.6 (November/December 2005)

Code

PNL13

Topic

Study Approaches

Topic Subcategory

Registries

Disease

Neurological Disorders

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