Transvenous Lead Removal Post-Market Clinical Study

RELEASE: Transvenous Lead Removal Using the Cook Evolution® Lead Extraction System Post-Market Clinical Study.

This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any indication it is used in the commercial setting within the United States and Europe. The purpose of this clinical study is to collect data on the performance of the Cook lead extraction devices for the purpose of supporting publications and presentations

Inclusion Criteria:

1. Patients must be 18 years of age or older
2. Lead indwell time greater than 1 year

Exclusion Criteria:

1. Patient is unable or unwilling to provide informed consent (per the IRB/EC requirements) to participate in the clinical study
2. Patient presents with an extracardiac lead