OUS Approvals: Neurostim And Cardiovascular Lead June Surge
Approvals of neurostimulation and cardiology devices dominated the list of non-US medtech approvals in June. According to Medtech Insight's Approvals Tracker, there were 36 medtech approvals outside the US last total that month, including 28 CE marks in Europe, plus approvals from China, Canada, Australia/New Zealand and Brazil.
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While demand for spinal cord stimulation (SCS) devices used in pain management continues to expand at double-digit rates, a small but growing number of highly innovative companies that develop stimulators to specifically target peripheral nerve pain is creating excitement among pain doctors looking for better options to treat an intractable population that's seen little success with standard therapy. With millions of people worldwide suffering from low back pain, severe headaches and migraines, neck pain and other chronic pain, the demand for safe, effective, percutaneously-placed devices remains high. In this article, we'll highlight emerging companies working on PNS devices and provide insights from pain physicians on the pros and cons of these devices.
The numbers of medical device approvals were up in most regions outside the US and the biggest surge, by percentage, was in approvals from emerging markets and the so-called BRIC countries. It remains to be seen if the trend will continue in 2018, but many companies are already counting on important non-US approvals coming in the next year.
DenerveX is a unique surgical tool used to ablate the nerve and capsular tissue on the posterior surface of the facet joint. preventing the nerve from reattaching with the goal of creating lasting relief from back pain that otherwise might require spinal fusion and/or treatment with opiate drugs.