LONDON, UK (GlobalData), 14 September 2012 - Precision Spine, a New Jersey-based spinal surgical device company, received 510(k) clearance for its Simplicity Solo Anterior Cervical Plate (ACP) System. The product is the third addition to the company’s expanding portfolio of spinal fusion treatments for degenerative disc disease. The clearance comes at an interesting time in the treatment of this disease in the cervical spine region. Not only is the product going to face stiff competition from similar ACP systems in the spinal fusion market, but it’s also going to contend against artificial disc replacements, a non-fusion technique. The company may have received FDA clearance in the midst of a paradigm shift in spine treatment.
The Simplicity Solo System is indicated to treat a variety of spinal conditions that result in either impaired stability or spinal nerve impingement. One such condition is Degenerative Disc Disease. This progressive disease is the result of aging and increased wear on the joints that connect the spine’s vertebrae, or intervertebral discs. As a person ages, these discs begin to thin and lose their original height. Adjacent vertebrae become closer together and begin to pinch projecting nerves, and even the spinal cord. This results in neck and radiating arm pain. Additionally, some discs become so worn down that their outer encasing layer tears and the gel-like interior begins to escape (i.e., herniated disc), leading to further nerve impingement.
In cases where nonsurgical treatment is ineffective to alleviate the pain in six months, patients will undergo surgery to replace the defective disc. A spinal fusion method of treatment has the surgeon removing the disc through an incision in a patient’s throat. This anterior approach is typically used in cervical fusion procedures to avoid contacting the spinal cord and nerves. The void left by the removed disc is filled with a substance called a bone graft, which promotes the growth of new bone to fuse the adjacent vertebrae together. To further increase the spine’s stability and prevent its collapse, surgeons will use plating systems such as the Simplicity Solo System. The system is composed of one or two level rectangular plates with screw placeholders for 4.5mm fixed and variable screws. These screws are inserted into the vertebral body of the affected vertebrae to affix the plate to the vertebral column.
The Simplicity Solo System is a next-generation product premised on the Simplicity Anterior Cervical Plate System. The previous generation is markedly different from its successor in that it uses two screws for stabilization in each vertebral body. Having a single line of screw placement (or midline fixation) offers several advantages to both the surgeon and the patient. For the surgeon, a midline fixation system provides improved screw visualization and easier screw placement, since the plating system is directly in line with the anterior incision. For the patient, the system minimizes the amount of lateral muscle retraction required for placement and visualization. Less damage to the muscles of the throat could equate to a quicker recovery time.
Precision Spine is introducing the next generation of the Simplicity System at a very interesting time. While all the large players in the spinal surgery market (i.e., Zimmer, DePuy, Medtronic) have had anterior cervical plating systems cleared by the FDA since 2002, their systems all boast the dual screw per vertebrae design. Precision Spine was progressive in their new product by offering the midline fixation feature. Only a handful of other spinal surgery companies offer devices with this configuration, including Pioneer Surgical and Globus Medical. While the growing trend of spinal surgeries is being reevaluated to incorporate a minimally invasive technique, there is a strong likelihood that these devices may be more heavily utilized than their dual-screw counterparts in spinal fusion surgery.
However, the utilization of Anterior Cervical Plating Systems industry-wide may face a slight upheaval in the coming years. Cervical Disc Replacements are likely to impact the Spinal Plating System market, which GlobalData estimates will reach $1.2 billion by 2018. The devices have proved in clinical trials to be equivalent to Anterior Cervical Discectomy and Fusion (ACDF) procedures in both neck disability measures and hospital duration. While equivalency is not a stimulus for a shift in treatment modality, some clinical trials have found that cervical disc replacements offer better patient mobility. One trial analyzed the neck’s range of motion for patients implanted with the Bryan Cervical Disc manufactured by Medtronic and for patients who underwent an ACDF procedure. On average patients implanted with the cervical discs maintained their range of motion over two years without any signs of motion degradation. However, patients who underwent the ACDF procedure had a much lower range of motion after their surgery, which decreased even further after the two-year period. If positive results from motion analysis studies continue to emerge, disc replacements are likely to become heavily adopted. Patients with symptomatic cervical disc disease already experience neck motion restrictions due to nerve pain. They are likely to flock to a treatment that offers them a chance to reclaim both the pain-free and nimble lifestyles that they were once accustomed to.
*Bad Timing? Precision Spine’s Cervical Plating System Cleared in the Midst of Treatment Shift
This expert insight was written by Joseph Gregory, GlobalData's analyst covering General Surgery Devices. If you would like an analyst comment or to arrange an interview, please contact us on the details below.
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