Reshaping Lives.
Innovators across several generations have shared the task of crafting a nucleus replacement option that seamlessly replicates the biomechanics of the native intervertebral disc. But it seems that one company— Spinal Stabilization Technologies™ (SST)—is close to making this a reality. The SST PerQdisc™ may soon be the safe, effective, nucleus replacement option that has been long sought after. A radically less invasive treatment for degenerative disc disease (DDD) could be right around the corner.
“SST is looking to reshape the landscape of spine care,” says Frank Phillips, M.D., Professor, Director, Section of Minimally Invasive Spine Surgery, and Director, Division of Spine Surgery, Rush University Medical Center in Chicago. “Nearly everyone will experience some degree of disc degeneration in their lifetime, which may present as pain and disability. SST’s approach to degenerative disc disease—replacement of the disc nucleus—has been sought after for decades. A breakthrough like this would offer surgeons a new surgical treatment for patients who previously have had very few options. The PerQdisc could make this happen.”
Acumen + teamwork got it done
“Due to a great deal of research, and teamwork involving numerous experts and clinicians, the SST team is on the brink of decoding the long-standing challenges facing disc nucleus replacement,” says company CEO Mark Novotny. “Soon, patients may no longer have to settle for fusion or no treatment at all. With the PerQdisc, they can go forward in their lives with an enhanced sense of freedom and mobility.”
The PerQdisc Nucleus Replacement System utilizes balloon technology, combined with a biocompatible polymer, to provide a customized, form-fitting prosthesis. The technology allows for excellent visualization of the device both intra-operatively and at post-op follow-ups.
The balloon technology enables surgeons to benefit from a series of images taken throughout the procedure. Armed with feedback allowing them to assess the extent of the nucleus removal, while simultaneously being able to visualize the integrity of the disc space, surgeons can make precise treatment decisions based on realtime feedback.
“The challenges that previously faced nucleus replacement technologies have been centered around subsidence, migration, and biocompatibility concerns. The data coming from SST suggest the PerQdisc is successfully addressing these issues,” says Hyun W. Bae, M.D., Professor of Orthopaedic Surgery, Co-Medical Director, Spine Education Cedars-Sinai Spine Center in Los Angeles. “An innovation like this would be of tremendous value to the spine surgeon community.”
The PerQdisc provides a custom-fit, patient-specific silicone prosthesis. Once the in-situ formed device has cured, the implant is designed to mimic the biomechanics of the native nucleus—the goal being to preserve disc height and maintain physiological range of motion (RoM).
“Based on the early clinical experience, I believe the PerQdisc has the potential to create a major shift in our practice guidelines for patient indications and surgical intervention,” says Carl Lauryssen, MD, Neurosurgeon, Central Texas Brain & Spine. “SST is addressing the pain generating nucleus with a device that recreates native physiologic motion and redistributes the weight-bearing forces in an anatomical fashion.”
Loud, clear data: nucleus replacement is here to stay
As there is no turning back the tide of customized medical treatment—especially when something works— patient-tailored (specific) disc nucleus replacement will only grow in popularity.
To date, SST has undertaken four clinical trials and is finding promising results. They began with the Nucleus 181, and Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy (LOPAIN1) studies. These clinical trials explored the safety and efficacy of implanting the PerQdisc using an anterior or lateral surgical approach, in patients experiencing pain and disability from DDD identified at a single level. This initial data showed the PerQdisc Nucleus Replacement System provided patients with a statistically significant reduction in disability, back and leg pain (when present), as well as reduction in pain medication usage at 6- and 12-months post-op. Additionally, the device has been shown to preserve disc height, maintain RoM, and resistant expulsion.
LOPAIN2 began enrollment in July 2022 and is gathering additional long-term safety data (up to 5 years) on the PerQdisc.
Patient enrollment is also underway for LOPAIN3, a study exploring the feasibility of implanting the PerQdisc using a minimally-invasive posterolateral approach on patients undergoing concurrent discectomy procedures.
SST is paying close attention to the lessons learned over nearly a decade of research on the PerQdisc and has been refining the surgical procedure and patient selection criteria.
Mark Novotny states, “Surgical technique and methodical patient selection are critical in achieving positive outcomes in patients undergoing the PerQdisc surgical procedure. As for the surgical process, two vital lessons we have learned are the importance of implant positioning as well as the value of preserving the native anatomy.”
“Everything is moving in the right direction,” says Novotny. “We are in discussion with the FDA to clear the way for a US IDE trial for the PerQdisc.”
No more settling for fusion
There is no shortage of data indicating that mobility is linked to quality of life, mental health, and longevity,” states Javier Duarte, M.D. Hospital Sanatorio Americano, Asunción, Paraguay. Dr. Duarte, who has performed 16 PerQdisc surgical procedures to date, adds, “The PerQdisc device and surgical procedure have been engineered to preserve and work with the patient’s native anatomy, the focus being to provide a motionpreserving disc arthroplasty with minimal tissue disruption. The data thus far indicate that this device enables patients to maintain segmental motion. An innovation like the PerQdisc will open the door to mobility for thousands, if not millions of people who are living with constant pain and disability.”
No more metallic balls wandering into vertebral bodies…or devices that move into surrounding muscle. David Cleveland of PMMA fame would be pleased…the next, next, next generation of his vision has arrived.