Encouraging Guidance

May has been a productive month for the neurotechnology industry, with a string of events bringing good news to investors and entrepreneurs. The FDA approval of Nevro’s Senza spinal cord stimulation system [see article, p2] was welcome news not only for the company and its investors, but for the industry as a whole, given the relative paucity of PMA approvals for implanted neuromodulation devices in recent years. Autonomic Technologies’ announcement of a $38 million investment round [see Financial News, p3] was also well received by the industry, given the reluctance of many VC firms to invest in implantable neuromodulation devices.

But perhaps the best news came from the FDA, in the form of two separate draft guidance documents that could dramatically improve the approval process for neurotech devices. The first draft guidance concerned patient preferences with respect to devices. According to the document, “The Agency understands that patients and caregivers who live with a disease or condition on a daily basis and utilize devices in their care may have developed their own insights and perspectives on the benefits and risks of devices under PMA, HDE, or de novo review. FDA believes that patients can and should bring their own experiences to bear in helping the Agency evaluate the benefit-risk profile of certain devices.” In essence, the FDA is acknowledging that a patient’s tolerance for risk may be considered by the agency when making approval decisions. “Some patients may be willing to take on higher risks to potentially achieve a small benefit, whereas others may be more risk-averse, requiring more benefit to be willing to take on certain risks,” the document says. This rationale may have been a factor in the FDA’s recent approval of EnteroMedics’ Maestro device, despite the failure to meet its primary endpoint.

The draft guidance goes on to say that it may be appropriate to approve a device based on a subset of the population for which an indication is requested when the probable benefit outweighs probable risks for that subset.

The second draft guidance document concerned what the agency calls “adaptive” trial design, which enables a clinical trial to be altered midstream in response to accumulated data. The trial sample size could potentially be reduced, for example, or the trial’s claim or hypothesis could be altered while the trial is underway.

The existence of these two provisions might have made a profound difference in recent neurotech device trial failures, including St. Jude Medical’s BROADEN trial for depression and Northstar’s Everest trial for stroke rehabilitation. But their inclusion in future trials may go a long way toward improving the outlook for new neurotech devices.

James Cavuoto

Editor and Publisher

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