While not necessarily at the forefront of discussion in the spine industry (the scintillating repartee amongst those debating the merits of price transparency within traditional fusion officially takes the cake), motion preservation devices have quietly gone about their business staying relevant in this ultra-competitive landscape.
Many key opinion leaders had written off dynamic stabilization products, such as Zimmer’s Dynesys after he U.S. Food and Drug Administration (FDA) insisted on seeing more clinical data on these devices, proving their efficacy.
However, the FDA’s demands were subject to interpretation at best. In 4Q09 they requested “postmarket surveillance” on products already at the commercialization stage. What does this really mean? While the U.S. dynamic stabilization market took a dip in 4Q09 and 1Q10 after this announcement, subsequent concerns over the future of this market have largely been overshadowed by what the industry considers more interesting matters. These include NuVasive’s admirable XLIF reimbursement recovery and industry veterans’ growing criticism of the proliferation of “me-too” products such as pedicle screws and cervical plates. Why, amidst much perceived despair, has motion preservation suddenly escaped major criticism in water cooler discussion amongst industry professionals? Some postulate that dynamic stabilization safety concerns may even subside dramatically by the end of the 2011. It is interesting to note that Interventional Spine, with its PERPOS system, who have a disparate percutaneous technology that arguably serves similar markets, appear to be unfazed by the mutable state of this market.
A possible explanation is the long history of motion preservation devices in Europe. Dynamic stabilization, interspinous spacers, and cervical discs are all viewed quite favorably amongst the surgeon community in Europe. The headwinds facing dynamic stabilization in the U.S. from the FDA did not, in any way, taint the European market; in fact some European surgeons were hardly even aware of these concerns. Perhaps the robustness of the global market quelled initial fears amongst the U.S. community. I digress slightly to mention that there is a nearly unanimous sentiment that lumbar discs need serious technological improvement in their load bearing characteristics to become more widely adopted. This is not just in the U.S. and Europe; surgeons in the Asia/Pacific region also agree.
Image source: Optikal