The Medtronic recall and the concern being expressed about the St. Jude Riata leads has left patients in fear that they have defective defibrillator lead wires in their chest that cannot be removed. Both Medtronic and the FDA have suggested that for most patients, removing the leads is not the best option because of the risks associated with the removal.
The good news, according to a recent article in Medical Device Week, is that medical technology is moving towards a safe and effective way to remove leads if they become damaged or dangerous to the patient.
Leads can become hazardous for any number of reasons, whether it is a question of faulty manufacturing like the defective Medtronic leads, or because they become infected or blocked over time. In the 1980s, most implantable leads were removed by mechanical sheaths. However, they were eventually replaced by power sheaths which were in turn abandoned for the newer laser sheaths. Cook Medical in Bloomington, Indiana has taken a more traditional approach in creating Evolution, their new tool for defibrillator lead removal and throwback to the mechanical sheaths of the ‘80s.
According to Cook Medical, the new Evolution mechanical dilator sheath boasts improvements over the traditional mechanical sheaths and has none of the drawbacks which plague the power and laser sheaths of today. The design of the original mechanical sheaths caused them to be somewhat awkward and require a large degree of physicality to operate.
The new Evolution design has eliminated this concern. They are not as bulky or as costly as the current electronic sheaths, and they are able to avoid the unintentional damage to surrounding tissue sometimes caused by their electronic counterparts. The mechanical Evolution does not require the additional capital equipment, annual maintenance and calibration, biomedical inspection, electricity source, or on-site laser officer necessitated by a laser sheath. Reportedly, the mechanical sheath also maximizes physician control.
The one silver lining in the Medtronic defibrillator lead recall debacle is that more effort is going into improving the technology for removal of defective defibrillator leads. Many Medtronic patients are reading this in fear that they will have defective lead wires in their chest for the rest of their lives and this breakthrough gives some hope to these patients. Hopefully, one day in the near future changing out leads will be simple surgery.
December 3rd, 2007 by Ronald V. Miller, Jr. with The Maryland Injury Lawyer Blog