Ciao, Italia! K2M, Inc. has announced the launch of the company’s MESA Spinal Systems and SERENGETI Minimally Invasive Retractor Systems in Italy.
K2M, Inc. Launches in Italy
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The top-loading MESA Spinal Systems feature Zero-Torque Technology, applying zero torsional loads, or twisting forces, to the spine when locking the screw. The systems offer a variety of screw types, and, says the company, “revolutionary instrumentation.” K2M indicates that these systems are uniquely designed to address the most difficult correction maneuvers, while providing the surgeon the ability to one-step lock.
The SERENGETI Minimally Invasive Retractor Systems feature a flexible polymer Retractor, which provides direct visualization and access to the screw heads to allow for simplified rod insertion. The Retractor is inserted with the screw, allowing for one-step, percutaneous placement of the implants.
“The innovative MESA and SERENGETI systems allow surgeons increased flexibility in their intraoperative decision-making, meeting a wide range of current unmet needs in spinal surgeries. The availability of new technologies for surgeons presents significant short and long term advantages to Italian patients, ” said Stefano Boriani, M.D., director of the Department of Oncologic and Degenerative Spine Surgery, Rizzoli Institute, in the December 4, 2012 news release.
“The Italian launch of MESA and SERENGETI marks another important milestone in K2M’s mission to be the global spine market leader, ” stated Eric Major, K2M’s president and CEO. “We look forward to bringing K2M’s full portfolio of breakthrough products to Italy, as it is critical to our commitment to patient care around the world.”
Asked about the location and timing of the launch, Major told OTW, “Italy is a major European market with unmet needs for K2M’s innovative comprehensive portfolio, particularly our complex spine and minimally invasive product offering. This launch is part of our strategic focus on expanding the K2M complex spine and minimally invasive brands. We have a significant number of key opinion leaders that have been pushing us to enter the Italian market and we believe our products are a perfect fit. The market is very forward thinking in its adoption of new innovative technologies and our core products, such as MESA Rail, RAVINE, and SERENGETI, cater to the surgeons’ needs.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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