by William Stuart
In June of this year, I attended a day of lectures at the International Neuromodulation Society Annual Meeting. One lecture made a particularly lasting impression. Dr. Joshua Prager gave an excellent presentation on Best Practices for Intrathecal Therapy and the FDA. The FDA portion was a late addition to this presentation, and I shall address this later.
Dr. Prager presented issues related to best practices when treating patients with intrathecal drug delivery (IDD). His presentation was developed with the input of many internationally known clinicians. I know many of you may have heard similar presentations at other meetings or in the literature. I, too, have listened to similar presentations, but this one gave me a new perspective; and I wanted to “re-convey” some of the key principles that were discussed. I shall paraphrase actual slide content.
Although this information is not necessarily new, it is good to be reminded of key concepts in treating patients with IDD’s to minimize adverse events.
Dr. Prager gave an additional presentation on the recent FDA’s Consent and Decree with Medtronic. There appears to be much controversy regarding this agreement, and I feel the need to share Dr. Prager’s presentation. Dr. Prager stated that this agreement imposes restrictions on Medtronic and it outlines steps to address issues related to changes in the design of the Synchromed Pump, including the process by which clinicians can continue to treat patients with this particular pump.
The agreement does not require a recall of the Synchromed pump, and there are no new safety issues with the currently manufactured device. Some of my clients have expressed concerns over an increase in liability with the implantation of Medtronic pumps. Documenting medical necessity is nothing new and I do not see how this changes liability. Some of these concerns are valid, and others may be inflamed by Medtronic’s competition. It appears to me that there is significant misinformation being distributed; and I suggest all who may be concerned to contact Julie Foster at email@example.com.
Dr. Prager made a particularly significant point at the end of his talk. Another implantable pump manufacturer whose product has documented medical safety issues related to MRI procedures is still currently engaged in treating patients with no FDA consequences. Interesting!
As always, I enjoy attending this meeting and benefit from the information presented.