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More Woes for Medtronic and FDA as ICD Leads Continue to Fail
For patients with a high risk of cardiac-related death, implantable cardioverter-defibrillators (ICDs) are usually a demonstrably favorable alternative to medication. Rather than taking medication, an ICD is implanted in a patient and will monitor the patient’s heartbeat. When an irregularity is detected, the ICD will administer a shock which should correct it. During implantation, the ICD is connected directly to heart by thing wires, called leads.
In December 2007, Medtronic, a major manufacturer of defibrillator leads, was forced to recall their latest model of leads, the Sprint Fidelis, because of reports of lead fractures. If fractured, the ICD is unable to function properly, and may either give unnecessary shocks or none at all. Clearly, this creates a significant health risk for patients in need. The danger becomes worsened by the fact that the surgery to remove or replace the leads is not without risk. In a March 2009 investigation by the New York Times, it was reported that at least 13 people were likely killed due of the faulty leads or during surgery to replace the defective leads.
Since the initial recall, the rate of failures has continually increased. So much so, UBS Analysis’ predict that the rate of failure at four years could be as high as 30%. This would be an astounding failure rate and will jeopardize patient health, and many patients would be required to undergo medium-risk surgery to replace the wires.
The monumental failure of the Sprint Fidelis brings to light FDA’s failings in its approval processes. When a company makes a minor change to an FDA approved device, it must seek new approval from the FDA. However, the threshold for a supplemental device is lower and the FDA has a much higher tendency to approve this type of device as opposed to new device applications. Because of this, companies have an incentive to seek approval of new devices claiming they have only been slightly altered from an already approved device.
When Medtronic released the Sprint Fidelis series, Medtronic advertised it as the next generation of lead wires. The Sprint Fidelis was advertised as thinner and easier to implant compared to the Sprint Quattro. It replaced their previous line of wires, the Sprint Quattro line. Despite the seemingly significant changes, Medtronic claimed to the FDA that the changes from the Sprint Quattro were only minor. Shortly after, the FDA approved the Sprint Fidelis based its approval of the Sprint Quattro. So while Medtronic told the FDA the changes were only minor, it went on to flaunt the changes as significant improvements over the previous line of leads.
The severity of this disaster only worsens as more patients experience failures. This situation reiterates the need for significant FDA reform. In this case, the FDA needs to ensure that a manufacturer is not advertising “significant improvements” to the public while declaring the changes only minor to the FDA. And in the least, the FDA must do a better job at thoroughly reviewing supplemental applications before approving them. After all, sometimes the changes aren’t so minor.