Becker's Spine Review

33 DEVICES & IMPLANTS Paradigm Spine Publishes Coflex vs. Decompression Study: 5 Insights By Mackenzie Garrity P aradigm Spine published its European study of coflex and decompression alone two-year trial results in the Jour- nal of Neurosurgery: Spine. The clinical trial is a prospec- tive, randomized, controlled, multi-center trial comparing de- compression alone to decom- pression with coflex Interlami- nar Stabilization to treat severe lumbar spinal stenosis. A total of 225 patients were enrolled in the study at seven sites through- out Europe with 91 percent fol- low-up at two years. Here are five study insights: 1. Patients in the coflex group ex- perience higher composite clini- cal scores, 0.017, as compared to the decompression alone group. 2. Decompression alone patients reported more loss of foraminal and posterior disc height main- tenance compared to the coflex group. 3. Patients in the decompression alone group had 228 percent more subsequent epidural steroid injections than the coflex group. 4. Coflex patients reported 2.4 times more improvement in walking distance measurements. 5. At the two-year follow up, the decompression alone group was 1.4 times more likely to be using opioids. n Spine Surgeon Dr. Bartolomé Oliver Performs 1st European Mazor Robotics Prolat Case: 4 Things to Know By Shayna Korol D r. Bartolomé Oliver of Barcelona, Spain-based Oliver & Ayats Institute performed Europe's first Mazor Robotics PROlat Case. Here is what you need to know: 1. Caesarea, Israel-based Mazor Robotics is a medical device compa- ny and manufacturer of a robotic guidance system for spine surgery. 2. PROlat is a single-position solution for placing pedicle screws and other spinal hardware in the lateral decubitus position with the Re- naissance Guidance System. 3. Dr. Oliver used PROlat to perform anterior lumbar interbody fu- sion using the oblique approach from the left lateral abdominal wall through a minimally invasive incision. Renaissance was used posteri- orly to complete the procedure with a percutaneous transpedicular fusion. "This approach saves time in the operating room and more importantly, is less invasive for the patient with decreased risks," said Dr. Oliver. 4. Mazor has also fulfilled orders for the PROlat application in the U.S., Thailand and Australia. n Johnson & Johnson CEO Alex Gorsky: 5 Key Notes on Amazon, M&A & More By Laura Dyrda J ohnson & Johnson CEO Alex Gorsky spoke with CNBC at the J.P. Morgan Health Care Confer- ence discussing tax reforms and the outlook for mergers and acquisitions in the medtech space. Here are five key trends from the discussion: 1. On tax reform: "We are very pleased to see tax re- form went through. e fact that we now actually have a competitive tax rate that we've got a construct in place to repatriate cash and earnings from overseas will give us much more flexibility and the opportunity to make us much more competitive." 2. Future acquisitions: "In terms of how [the tax bill] will fundamentally affect our overall M&A strategy, I don't think that it really will. Really, that starts with science, the right deal, the right company, the right cul- ture, being able to integrate it in. But it certainly gives us more flexibility and makes us more competitive in the long run." 3. Amazon entering the market: "What I would say about Amazon is we have a very good partnership with them on the consumer side and we are talking to them, we sell through many of the big chains we work with, and we also sell directly, but what I would encourage anybody — whether it's in pharma, med device, OTC — we should all be acting like Amazon is getting into our business because, frankly, we've got to create a cri- sis. We have to make sure we're always competitive, that we are always thinking about how can we be more effective, how can we be more efficient?" 4. Would you welcome Amazon in?: "If it leads to bet- ter customer satisfaction, price transparency, for exam- ple around pricing, if it leads to better satisfaction for patients, then of course I welcome them in." Are you in talks with them?: "I won't go down that road right now. I think having healthy competition can be a positive thing. e important thing is to keep the pa- tient and consumer in mind." 5. Consumer segments: "Our consumer segment has been a core, iconic brand for Johnson & Johnson, whether it's baby products, Neutrogena, Avena or Tylenol. We have some great franchises and while they did perform down slightly they were actually about flat in the third quarter and the third quarter of the year and earlier part of the year…we remain very confident in that franchise." n

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