For many years, the Lateral surgery has been the most popular trend with most of the companies investing in trainings and launching new products because of the many advantages of this technique. The major advantage of XLIF/DLIF is the fact that the procedure does not require a second access surgeon. Other advantages are reduced incidence of ileus, the anterior longitudinal and posterior longitudinal ligaments remain intact, the lack of need for bony resection as performed when posterior approaches for interbody fusion are being used, reduced operative time in comparison to other anterior approaches, and reduced postoperative hospital stay and analgesic requirements.
But during the last couple of years, the number of ALIF products launched in the spinal market has been growing mainly due to the impact of the new technologies and the spine industry trends. The Stand alone as well as the 3D printed cages have revolutionized this Anterior Lumbar Devices segment with almost 50 companies launching ALIF´s in the last year.Please, to know about 57 differentiated ALIF cages, visit:https://thespinemarketgroup.com/category/alif/
Although the ALIF approach has always been advantageous because unlike the PLIF and posterolateral approaches, both the back muscles and nerves remain undisturbed and provides better initial stability of the fusion construct, it is also true that there are major risks to the ALIF approach since the procedure is performed in close proximity to the large blood vessels and the risk unique to this approach is that approaching the L5-S1 disc space from the front has a risk of creating a condition known as retrograde ejaculation.But in spite of those risks associated, it has become a good alternative to the Lateral for many indications.
Anonymous says
Motion Preservation Corpectomy Devices. The different devices presented are identified by “Descriptions” as to their construct and functionality in being adjustable so as to meet the demands of restoring various sized spaces following the removal of the diseased anterior body of the vertebra along with the adjacent discs both superior and inferior to the adjacent healthy vertebra. The illustrations are identified by a legend for a fuller understanding of their components that demonstrate their adjustability and functionality in providing restoration of the spine following a corpectomy surgical procedure with motion preservation having compression, flexibility and constrained rotation. The artificial discs associated with the space restoring adjustable corpectomy body are notably different in the manner that they are made but all are designed for motion preservation to the surgically restored segments of the spine while providing for fusion to the superior and inferior end plates of the adjacent healthy vertebra with stabilization of the newly implanted attached adjustable rigid body of the implanted corpectomy device . Please note that the corpectomy device shown in Fig. 13 is quite different in regard to the placement of the motion preservation component of the corpectomy device as it is positioned at a place normally where the removed diseased vertebral body was previously located. The spine surgeon who I was working with had some doubt as to its efficacy as it does not theoretically represent the normal restorative position for a corpectomy device. But then again there are no corpectomy devices that provide for motion preservation in conjunction with fusion and as motion preservation was an important feature of the patent in restoring functionality of the restored site I had to “ think out of the so called box” based upon the “Three Dimension Spinal Theory presented by Dubousset in his attached article. In fact all of the artificial discs being presented by me are based upon his theory that the spine surgeon should not be so concerned with the segments of the spine being fused but rather with the adjacent healthy vertebra above and below the segments of the spine being fused as this will result in limiting their functionality thereby resulting in a cascading effect of continued degenerative disc disease of the spine.
It is anticipated that the corpectomy devices with motion preservation as previously identified provide for a potential substantial growth in the spine market place as the devices will only require a 510k based upon humanitarian exemption without PMA approval as they are considered a last resort device for individuals where all other remedies have been exhausted or are not applicable. By example people are living longer and due to pathological conditions such as osteoporosis resulting in non-
restorable fractured vertebral bodies or in instances where increasing uses of vertebroplasty and kyphoplasty have failed or conditions of “burst fractures” resulting from trauma necessitating the removal of the anterior body of the vertebra and lastly in individuals with metastatic cancer of the spine. Most notably, there are embodiments and claims within the patent that allow for drug eluting factors to enhance osseous integration of the end plates of the devices as well as embodiment and claims for drug eluting factors for dealing with infections, controlling hemostasis, and anti-tumor factors that address cases with metastatic cancer of the spine and pain controlling factors so as to reduce post surgical need for pain medication(articles attached) so as to have the patient relatively pain free following the surgical procedure and mobile after a rather shortened post operative recovery period.
The corpectomy devices may also have a temporary rigid bioresorable collar that is designed for preventing movement of the artificial discs so as to enhance fusion of the end plates of the corpectomy device and after a period of 6-8 weeks said collar resorbs and the attached artificial discs are now
capable of restored motion preservation having flexibility and compression with limited constrained rotation so as to mimic the movement of a natural vertebral disc.
After successful performance of the corpectomy devices I suggest that we spin off the artificial discs from the device and present them to the FDA under a 510K demonstrating equivalency to
existing devices thereby negating the need by the FDA for extensive and costly PMA studies.
I have provided information in regard to the artificial discs as well as illustration and comparison to all other known artificial discs now under investigational studies. It should be noted that none of the artificial discs noted mimic a natural disc by providing for flexibility, compressibility and constrained rotation. As a result all of the artificial discs now under investigation are limited for use at a single level and this is a distinct limiting factor in their use as an artificial disc.
It is evident that with such devices excessive forces will be transmitted to the attached vertebrae above and below the sites being restored and this is the reason why the Charite and Prodisc were not approved for being reimbursable by insurance companies which is an essential ingredient for success in the artificial disc market place. When the 2 aforementioned devices were placed at 2 levels of the spine the surgeon made the decision to remove one of them and use plating to fuse the other vertebra involved. His decision was based upon the observation of instability of the 2 levels restored as it appeared to be potentially destructive which may result in potential harm to the patient and the representative from the spine implant company was the first to make the observation and request for the removal of one o the implanted devices in anticipation of a law suit as the devices were only approved for use at a single level.
In closing, I believe that the intellectual property presented complements and provides another vital dimension to the value of the products purchased by Precision Spine with a committed user base for fusion related devices such as plating, compliant screws and rods and pedical screws. These are exciting times as it is believed that the spine market place is in a recovery mode with expected returns far greater than that experienced in the past and I believe that my intellectual property will provide the needed pathway for Precision Spine to outgrow and distance itself from your large number
of competitors in the current limited fusion market place.
Please feel free to call me if you have any question and I look forward to meeting you and Rich and you associates as to further exploration of what is being proposed in this correspondence.
Warm regards, Howard
Cell # 917-846-3399
1. U.S. Patent # 6,454,806 ( inadvertently abandoned by my ex-partner for not paying the maintenance fee which I believe we can retrieve from the U.S. Patent Office by paying the fee along with a penalty fee)
2. U.S. Patent # 6,719.796
3. U.S. Patent # 7,282,063
U.S. Patent # 7,824,445
Howard Cohen says
Looking to license intellectual property for Motion Preservation Spinal Devices via an anterior approach