Polyurethane Pacemaker Leads

The Contribution of Clinical Experience to the Elucidation of Failure Modes and Biodegradation Mechanisms
  • Ken Stokes

Abstract

The term “clinical study” can mean many things. Premarket clinical studies are necessary to verify the safety and efficacy of a new device, but they may not be able to detect low-level or long-term complications. No matter how much premarket work one does and no matter how sophisticated the protocols, the only valid proof of long-term reliability is performance in the field; that is, through postmarket surveillance. Even studies on the long-term performance of marketed products may be misleading if not done appropriately. Clinically based postmarket surveillance can reveal the true actuarial survival of a device and the clinical mode of failure. Analysis of returned products may be required to understand the details of failure mechanisms per se.

Keywords

Silicone Rubber Cardiac Pacemaker Cardiac Pace Conductor Fracture Pacemaker Lead 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media New York 1998

Authors and Affiliations

  • Ken Stokes

There are no affiliations available

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