SE will be releasing a retrospective two year follow-up in the first quarter of 2010. In all likelihood, this will be the first retrospective data presented on the efficacy of this type of device. This will be an important report, since "zero-profile" devices have yet to prove that non-union rates are not the same as an interbody device without anterior fixation. Recently SE had a paper published by Choll Kim, M.D. of San Diego that discussed the simplicity, versatility and ease of use when implanting this device into multiple levels without associated dysphagia. This device allows the surgeon the option to address multiple levels off-label. In addition, there has been documentation and biomechanical testing to substantiate torsional stability. A device that can be inserted with a minimally invasive approach, reducing surgical time, no plate sizing, no plate bending, and with a proven track record we're not talking about Quantum Orthopaedics, we're talking Spinal Elements. TSB wants to know what our readers think? Stop by the SE Booth next week, who know's you may even run into TSB. Cheers!
Saturday, November 7, 2009
Quantum Orthopaedics, Nope! Spinal Elements!
Mosaic: arbitrary patterns resembling a composition made of diverse elements. TSB is not speaking about a decoration made of stone or small glass, TSB is speaking of Spinal Elements which was the front runner pioneering a device and concept that has been the platform for all zero profile implants. The Mosaic was the first all in one device that combines interbody support with a tension band, designed in 2, 3, and 4 hole configurations. This product has stood the test of time.
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A point of clarification here. The Mosaic is NOT a zero-profile device. It integrates a cervical plate body with an intervertebral cage, but the screw holes are located in an anterior projection overlying the adjacent vertebral bodies. The anterior profile of the Mosaic is really no different from a standard cervical plate with a separate cage.
ReplyDeleteIn order to be zero profile, no portion of the device can be anterior to the anterior longitudinal ligament. The Synthes Zero-P and a few others are truly zero profile. The difference is that in the zero-profile devices the screws are engaged though the interspace at an angle. In this case no portion of the device as anterior to the anterior longitudinal ligament.
TSB respectfully needs to make a distinction between an integral plate/cage (like the Mosaic) and zero profile interbodies with fixation (Zero-P, Stalif, etc.). They are quite different concepts.
SpineDoc: I never said that the Mosaic was a Zero-Profile device, I said that "SE was the frontrunner pioneering a device and concept that has been the platform for zero-profile devices." Thanks for your input, I understand that they are different concepts.
ReplyDeleteTSB - Other than a sales pitch for Mosaic, I don't get the point of this post. Calling Mosaic a "platform for all zero profile implants" is laughable considering Mosaic isn't zero profile
ReplyDeleteYou must admit it was the first design of its kind that addressed differentiating the standard modality of treatment. As far as a sales pitch, I do not sell the product, nor do I have any affiliation with the company. But TSB respects your opinion, that's what the blog is all about.
ReplyDeleteI don't see the huge advantage of this- but different strokes for folks. The product is billed as minimally invasive (arguable less invasive) and no need to bend or size. I can easily say the ability to bend or size is an advantage of the way its aways been done. This sound like the old adage- if you can't fix it, feature it. If it was an advantage to have a plate that didn't require bending, then why do surgeons bend plates in the first place. As said before, this isn't Zero-P. The offset unilateral screws are marginally interesting but does this really meet your new, true and make a difference criteria? It doesn't meet mine.
ReplyDeleteDavid: Great commentary! Like TSB always says, this is your blog and the point of blogging is to get the publics opinion about what is perceived to be beneficial not only to the patient but also to the industry. Even TSB knows when to be humbled by our readers opinion. This is your blog based on a democratic process. Thanks for your input and keep reading.
ReplyDeleteAny other devices that are new, true and make a differences in the last 10 years?
ReplyDeleteScientx was the first with this product, in fact the exact product (both peek and Ti.)Patent Number 6,235,059. The only innovation is that SE has done a better job marketing someone else's idea.
ReplyDeleteMedical Device Ventures: You are correct! But you know what they say in the spine industry; "the race goes to the swiftest!" Thanks for keeping it real and keep on reading!
ReplyDeleteSynthes is not zero-profile either. Your device is only offered in a footprint that is 17.5 mm wide requires the device to be pulled anteriorly to get the screws in. In other words you cannot recess this implant which can truly make it zero-profile unless you garden out some of the anterior portion of the vertebral body to accomodate your screw trajectory. Mosaic, Medtronic Pervail are are not zero-profile and they have plates in which you have to do some anterior work with a burr on the outer vertebral body to make it zero-profile.... The same goes for globus.
ReplyDeleteThis U.S. market was created by STALIF and Paradigm BioDevices. They were two years ahead of SynFix. Before that (2004) zero-profile didn't exist in the spinal lexicon. In fact, Stand-alone cages were taboo due to failure s in the 90s of BAK and Ray TFC.
ReplyDelete