The spine can be considered the human body’s suspension system, where the intervertebral discs act as shock absorbers. Simply put, the discs and surrounding ligaments absorb the shock and redistribute the load whenever our body, especially the spine, is loaded in different planes of motion. Over time, spinal discs are subject to degeneration. The constant pressure, combined with the natural tendency of the body’s tissues to dehydrate and lose volume as we age, can cause the discs to deteriorate and become less resilient. And, in many instances, dysfunction of the inner portion of the disc (nucleus pulposus), can contribute to discogenic low back pain (dLBP).
Today, back pain is disrupting the quality of life for approximately 40 percent of the adults over the age of 40 and close to 80 percent of people over the age of 80. Although some might attain temporary relief through conservative treatment options like physical therapy, pain management drugs, or various spinal injections, others may be unresponsive and need to turn toward surgical options. Some patients may benefit from decompressive surgery to relieve pinched nerves while others require more involved interventions, such as spinal fusion or total disc replacement (TDR). Although spinal fusion can relieve pain, it does so by eliminating motion, thus altering the spine’s flexibility, and placing an increased biomechanical requirement on the adjacent levels. On the other hand, total disc replacement (TDR), is a motion preserving surgical option, but requires total removal of the disc. Limited implant sizes, in addition to requiring a large exposure to the disc, can add challenges to the TDR procedure.
A potentially less invasive alternative surgical treatment, The PerQdisc™ Nucleus Replacement System, was conceptualized by two interventional radiologists after observing instances where spinal fusion would initially reduce or eliminate pain, but after time the altered biomechanics led to adjacent segment degeneration. While these shortcomings in conventional surgical methods were fairly evident in the industry, they sought to develop a potentially less-invasive, motion-preserving surgical option designed to leave the disc intact and reduce or eliminate the problem of adjacent segment disease. Their efforts led to the inception of Spinal Stabilization Technologies (SST), a company through which the PerQdisc Nucleus Replacement System was engineered and developed. After seven years of research and development and three clinical trials, SST received its first regulatory approval, the CE mark, for their PerQdisc Nucleus Replacement System.
Currently, SST is facilitating a treatment option that is not only less invasive but is also intended to preserve the spine’s natural range of motion. “SST stands as the only company to offer a commercial Nucleus Replacement System, which is exceptionally focused on minimal tissue disruption of the intervertebral disc,” says Mark Novotny, CEO of SST. The PerQdisc aims to limit tissue resection to the diseased pain-generating nucleus pulposus, leaving the outer portion of the disc intact. The idea is to preserve as much native disc anatomy as possible, removing only the painful, poorly functioning nucleus. If additional surgery is required in the future, the treated level is left primarily intact allowing for many other surgical options.
Under the Hood of PerQdisc Nucleus Replacement System
The PerQdisc Nucleus Replacement System’s components and surgical techniques are designed and engineered by SST to address previous nucleus replacement technologies’ deficiencies (migration, subsidence, and expulsion). By leveraging the PerQdisc’s capabilities, the surgeons can minimize tissue disruption and provide motion-preserving, personalized, form-fitting implants for their patients. The PerQdisc can be deployed using either a standard anterior retroperitoneal or lateral trans-psoas surgical approach. “The procedure only requires a small portion of the disc to be exposed when placing the implant, making it a relatively safer and lesser invasive procedure for the patients,” adds Novotny. Under fluoroscopic guidance, the implant is deployed using a four-step procedure. First, the annulus is dilated to create an opening to remove the diseased nucleus pulposus. Next, the nucleus material is removed to create a cavity for the implant. A series of imaging balloons are then introduced to access the disc space. And finally, the implant is positioned and, with pressure monitoring, is filled with a two-part RTV silicone polymer that cures in-situ. Once cured, the custom fit PerQdisc mimics the biomechanics of the native nucleus. The silicone polymer allows for load sharing with the vertebral endplates and annulus fibrosus.
Empowering Spine Surgeons with New Capabilities
Since receiving its CE Mark, SST is striving to gain prominence in the spine sector. To do so, the company is taking steps to equip surgeons worldwide with its innovative technology. SST provides surgeons with a comprehensive, multi-phase training program, from which they can gain a complete understanding of the PerQdisc surgical procedure.
We are always committed to maintaining comprehensive clinical support with on-call personnel for device troubleshooting and patient consultation
Essentially, the training program allows surgeons to master the procedure in an environment where they can effectively learn the nuances of the nucleus replacement surgery. When the surgeon completes the training program and is ready to perform their first live case, SST appoints a surgeon proctor to provide real-time peer-to-peer assistance. SST also assigns a clinical specialist to support the surgical team during subsequent procedures. “We are always committed to maintaining comprehensive clinical support with on-call personnel for device troubleshooting and patient consultation,” mentions Novotny.
To further set SST apart, the company maintains a PerQdisc Registry and undergoes Data Review, both of which are available to participating surgeons. SST uses an electronic data capture system (EDC) which allows surgeons to assess the PerQdisc performance while monitoring their patient outcomes. In addition, surgeons can utilize the EDC system to generate summary reports and conduct periodic data reviews with SST experts.
SST stands as the only company to offer a commercial Nucleus Replacement System, which is exceptionally focused on minimal tissue disruption of the intervertebral disc
Presently, SST’s technology is proving extremely promising in treating discogenic low back pain (dLBP). Thus far, the data gathered from clinical trials has shown the PerQdisc significantly decreases disability (based on the Oswestry Disability Index). The patients are witnessing a reduction in leg pain (if present) within 6-12 months after surgery. Equally important, the PerQdisc implant has proven to be resistant to expulsion and maintains biomechanical range of motion at the treated level.
The Drivers behind the Innovation Engine
SST’s management system instils strong leadership including hiring and retaining very experienced managers that run their functions autonomously. Typically, the function is lean and uses a senior manager that builds an extensive network of subject-matter experts. This allows the function to be fully optimized, compliant and have best-in-class problem solving capabilities. The staff plays a crucial part in providing positive outcomes for both surgeons and their patients. Notably, the workforce goes the extra mile in consistently communicating with surgeons worldwide and gathering crucial feedback regarding their experience with the PerQdisc technology. This feedback is then used to improve the existing offerings and develop new products to enhance the PerQdisc surgical procedure. In addition, SST collaborates with surgeons and regulatory agencies around the globe to raise awareness of discogenic back pain and help design programs that will better define patient populations that may benefit from nucleus replacement surgery.
SST’s top-tier management promotes a culture of innovation and excellence within the company. The company’s president, Mark Novotny, has an incessant passion and commitment to the company’s goals and objectives in bringing innovative and sustainable technologies to market. His focus is pinpointed, his enthusiasm contagious, and his attitude is incredibly tenacious in how he overcomes each obstacle. By instilling these qualities into the company’s workforce, Novotny creates an environment of guidance and encouragement combined with cohesive teamwork.
Paving the Way for Sustainable Medical Technologies
While the unique work culture will always be the cornerstone of SST, the company will further focus its efforts to provide remote education to surgeons, including case reviews, surgical technique updates, and discussions on interesting and challenging cases. SST has plans to conduct large-scale clinical programs to support regulatory filings and expand its PerQdisc technology indications. The company intends to conduct clinical trials in the U.S. and China while simultaneously conducting a Post Market Clinical Follow-Up (PMCF) trial in all countries initiating the launch. Together with its physicians, SST expects to publish data extensively, providing updates on the data coming from these different trials.” All in all, we will continue to iterate our technology with new features based on customer feedback, striving to ensure that both surgeons and patients can access the best treatment approaches for DDD,” concludes Novotny.
Description Spinal Stabilization Technologies, Ltd develops novel technologies for treating patients with lumbar discogenic back pain. The company has extensive worldwide intellectual property. The products and techniques SST develops are based on the philosophy that less invasive surgery may be associated with better clinical outcomes. These products and techniques could improve the lives of many patients that have limited options for treating their back pain. The company is focused on evidence-based medicine and plans to conduct numerous clinical trials.
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