Sacred Ground

Deep brain stimulation (DBS) has been one of the most successful product categories that the neurotechnology industry has seen. However, it is in the interest of DBS manufacturers to take heed of potential complications that may tarnish the reputation that these devices have earned in recent years.

As senior technical editor Warren Grill points out in his article this month [see p1], vendors and clinicians need to be aware of the risks of intracranial hemorrhage associated with neurosurgical procedures and microelectrode penetration. Though preliminary studies seem to indicate that less than one percent of procedures result in permanent damage, even this level needs to be reduced as much as possible. Brain surgery is inherently invasive, and there will always be some risk of tissue damage. But vendors would be well advised to look for new biomaterials, implantation procedures, and imaging techniques to reduce the risk. One goal worth pursuing is to try to achieve as close a match as possible in mechanical properties between brain tissue and electrodes.

Aside from hemorrhage, another study points out more reasons for suboptimal outcomes from DBS surgery [see Research Highlights, p5]. These include misdiagnosis, improper patient screening, suboptimal electrode placement, improper programming, and lack of medication adjustments. Manufacturers of DBS systems need to devote considerable attention to the training of clinicians, surgeons, and other health professionals involved in patient selection, device programming, and follow-up treatment, even if that process slows the initial rate of device sales.

Now that there are several vendors besides Medtronic producing devices to be implanted in the brain, including ANS, Boston Scientific, Neuropace, Cyberkinetics, Northstar Neuroscience, and others, it would be in everyone’s interest to share device safety information so that each competitor can minimize the number of adverse incidents. Foolish indeed is the vendor who markets their device by denigrating the safety of a competitor’s implant. As we saw with the meningitis scare associated with cochlear implants a few years ago, a problem with one vendor’s device can wreak havoc on an entire industry.
In the end, the best approach DBS vendors could take is to be open and forthcoming with the public about all risks associated with their devices. The credibility they gain with customers, clinicians, and regulators in the long run will more than offset any short-term loss of sales.

Human brain tissue is sacred ground to patients, surgeons, and specialists—indeed the final frontier of the neurological disorders field. Neurotechnology vendors who inhabit this frontier, no matter how briefly, would be wise to tread lightly with their devices and interventions.

James Cavuoto
Editor and Publisher