Closing the Approval Gap

The neurotech industry has benefitted greatly from new device approvals in recent weeks. Most significant is FDA approval of Neuropace’s RNS device for epilepsy. After an excruciating wait that tested the endurance of entrepreneurs, investors, and investigators alike, the cortical stimulation system is now approved for treating adults with partial onset seizures who have failed to respond to two or more antiepileptic medications [see article, p3]. An FDA advisory panel also recommended approval of the Cochlear L24 hybrid implant, which would open the neurotech market to individuals with partial hearing loss.

Also this month, Boston Scientific announced CE Mark approval for its Vercise DBS system for the treatment of primary and secondary dystonia. The approval opens up a second application for Boston Scientific’s DBS system, which is already on the market in Europe, Australia, Israel, and Columbia for treatment of Parkinson’s disease. The company earlier this year launched its INTREPID clinical trial in the U.S., which it hopes will lead to FDA approval of Vercise in the next year or two.

The differential between European and U.S. approval times for neurological devices continues to be an issue confronting entrepreneurs and established neurotechnology firms. An analysis conducted by Boston Consulting Group revealed that the time between CE Mark approval and FDA approval, which was already 38 months on average in the years between 2000 and 2005, increased to 47 months—nearly four years—in the period between 2006 and 2011.

There are signs that this approval gap may shrink in the years ahead. In response to mounting criticism, the FDA’s Center for Devices and Radiological Health has taken steps to streamline the approval process, including a new “Innovation Pathway 2.0.” Also, there are indications that the European Parliament may tighten medical device regulation in the years ahead, in part because of well publicized device failures with breast and hip implants. According to an article in MD+DI magazine, manufacturers will be required to submit more clinical data and there will be more oversight of the notified bodies—the third-party reviewers that perform device approvals in Europe. A new Medical Device Coordination Group will provide greater scrutiny of notified bodies. And a new Assessment Committee for Medical Devices has been established to monitor higher-risk medical devices.

Still, European regulators recognize that the gulf in device approval times presents a competitive advantage for European device makers over U.S. manufacturers, so they are unlikely to implement a centralized device regulation agency like the FDA. But to the extent that FDA device approval times can close the gap with CE Mark approval times, the U.S. neurotech market will benefit.

James Cavuoto

Editor and Publisher

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