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In the late 1980s, a team of product managers and engineers from Cook Medical began working with a small group of doctors to design medical devices. Their work helped to create the first devices for removing leads. We’ve continued to work with doctors around the world to offer new devices that help patients get back to living.
The Evolution RL is a rotating sheath (hollow tube). When the doctor pulls the Evolution RL trigger, the inner sheath rotates to help separate the lead from the scar tissue.
The Evolution RL gives the doctor full control over the sheath’s rotation. This helps protect the blood vessels and extra leads that may not be taken out.
The Needle’s Eye Snare is a looped wire that is inserted into the blood vessel through a sheath. The loop is tightened around the lead, which gives the doctor a firm hold in order to pull it out.
The Needle’s Eye Snare is the only device cleared for femoral lead removal. The Needle’s Eye Snare tightens around leads that are either attached to the heart or abandoned, even if they are broken. Without the Needle’s Eye Snare, a broken or damaged lead may need to be removed through an open chest procedure.
Potential risks related to lead extraction procedures include:
If you have concerns about any of these risks, ask your doctor.
If you don’t have an infection, your doctor could choose to abandon the lead (leave it in place) or have it removed. Abandoning the lead has a similar effect on long-term survival compared to lead extraction. But, if your doctor does remove the lead, there is a lower risk of device infection for the first five years.3
If you need your lead removed in the future, any abandoned leads that were left inside your body could make it more difficult or dangerous to remove your current lead.4
Rotational lead extraction procedures have clinical success rates of more than 99% and major complication rates between 0 and 1.5%.5,6,7
Depending on your unique situation, you and your doctor will weigh the risks of abandoning or removing the lead to make the decision that is best for you.