What spine surgeons have long wanted — an effective nucleus replacement system to alleviate patients’ pain

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The idea of nucleus replacement has been discussed by physicians for at least 20 years. This interest has driven multiple companies to work on developing a long-term implant.

With recent breakthrough technology developed by Spinal Stabilization Technologies™ (SST) and their introduction of the PerQdisc™ Nucleus Replacement System, surgeons now have a new option for their patients.

Becker’s Spine Review recently spoke about PerQdisc with Mark Novotny, CEO of Spinal Stabilization Technologies, along with two spine surgeons:

  • Michael Hess, MD, a spine surgeon in Germany, who is the Coordinating Investigator for the SST clinical trial program.
  • Hansen Yuan, MD, a retired professor of orthopedic and neurological surgery at the State University of New York Upstate Medical University in Syracuse. Dr. Yuan is a past president of the North American Spine Society and former editor of the International Journal of Spine Surgery

Spinal Stabilization Technologies and PerQdisc provide a unique solution for nucleus replacement

Dr. Hess explained that the main issue with previous nucleus replacement attempts was that the implant did not stay inside the boundaries of the disc. There was a high rate of expulsion. This expulsion could result in the implant moving which could cause problems for the patient.

The procedure that SST has developed, for nucleus replacement of the lumbar spine, is unique and effective. “In some patients the nucleus itself can be the pain generator,” Mr. Novotny said. “So, when you take the nucleus out, the patient may have significantly reduced pain levels very quickly. In many patients the outer portion of the disc, the annulus, may be largely intact and healthy, so our nucleus replacement device has been engineered to work with the annulus to bear weight and allow for motion of the segment.”

Mr. Novotny describes how SST’s procedure includes imaging techniques that allow the surgeon to visualize each step of the procedure. “There’s no blind implementation,” he said. “We have a specific tool kit for prepping the area to receive the PerQdisc implant. There’s a series of images taken during the removal of the nucleus that provide the surgeon with feedback on how much material they’re removing and how the disc is tolerating the removal step of the procedure.”

“We have a specific tool kit for prepping the area to receive the PerQdisc implant. There’s a series of images taken during the removal of the nucleus that provide the surgeon with feedback on how much material they’re removing and how the disc is tolerating the removal step of the procedure.” Mark Novotny CEO of Spinal Stabilization Technologies

After the nucleus removal is complete, the surgeon then uses a series of imaging balloons to visualize the space that has been created to understand what the geometry of the implant will look like. “Because each disc is different,” Mr. Novotny said. “This is a custom implant for each patient.”

Also unique is a system to test the integrity of the annulus prior to implanting. “The physician goes in with a test imaging balloon that pressurizes the disc space from the inside to get feedback on the integrity of the annulus,” Mr. Novotny said.

After removal of the nucleus and testing of the disc space has been completed, the PerQdisc is implanted. The PerQdisc is filled with a two-part silicone polymer that cures in situ. The implant has a series of marker beads embedded into the balloon so the surgeon can see the orientation of the PerQdisc. During filling, the surgeon can see the polymer filling the implant, in real time.

“The polymer science is very advanced, the imaging is very advanced and some of the procedure steps are quite unique,” said Mr. Novotny.

SST’s innovative nucleus replacement is supported by compelling clinical data

Dr. Hess said clinical data shows in the majority of patients operated on with SST’s procedure, “We were able to correctly identify the pain generator, remove the nucleus, and properly position the implant.” He also mentioned the important outcome of significant reduction in back and leg pain and the resulting improvement in patients’ overall daily activities.

Mr. Novotny focused on what the data from studies has shown.

The PerQdisc nucleus replacement system:

  • Significantly reduces disability
  • Significantly reduces leg pain six to 12 months after surgery
  • Reduces the level of pain medication needed between six and 12 months after surgery
  • Is highly resistant to expulsion
  • Enables patients to maintain their range of motion

Dr. Hess mentioned that although the data collected to date shows extremely positive results, it’s important to continue doing PerQdisc procedures and collecting even more data.

PerQdisc will be able to help a large number of patients

SST’s formal indication for PerQdisc, shared by Mr. Novotny, is: “The PerQdisc replaces the nucleus pulposus of the intervertebral disc in the L1 – S1 spinal region in patients with single-level discogenic pain. The patient may have single or multi-level degenerative disc disease but the discogenic pain must be limited to a single level.”

The surgeons offered their own practical perspectives on indications for use and on which patients are good candidates for this procedure. Dr. Yuan sees the true indication as “early to moderate degenerative disc disease with discogenic back and also leg pain,” and Dr. Hess added, “a patient with an almost normal looking MRI and severe pain.” Dr. Hess said, “You do not want to do a fusion or a bigger surgery; you’re looking at something that doesn’t burn any bridges, that leaves all possibilities open.”

“Almost every patient we are doing a fusion on for discogenic back pain is a candidate,” Dr. Yuan said. He sees the PerQdisc procedure as a much less invasive approach and believes over time it could be done endoscopically. Dr. Yuan was also encouraged by minimal expulsion rates with the PerQdisc, as “One of the biggest concerns with nucleus replacement has been expulsion.”

Also, both Dr. Yuan and Dr. Hess agreed that revision surgery for the PerQdisc would not be difficult and surgeons will welcome and adopt the PerQdisc

Mr. Novotny believes that since surgeons have been interested in nucleus replacement for years, they will be excited to provide the PerQdisc procedure as an option for their patients. There are many patients currently without a good surgical option and he anticipates surgeons will be extremely receptive to a nucleus replacement procedure that effectively reduces pain.

Dr. Yuan agreed and offered practical reasons for why he expects surgeons to adopt this procedure. He believes surgeons will like that the procedure is minimally invasive, has a faster recovery time and enables patients to maintain their spinal function, and that the implants have an indefinite lifespan. He also sees surgeons adopting because they will be able to perform outpatient procedures in ASCs.

“In the area of degenerative disc disease, the artificial nucleus replacement approach is a truly revolutionary thing... It will truly maintain a patient’s function, with no consequences or other associated problems. This is almost like getting the silver chalice. It is what we all have been looking for.” Dr. Hansen Yuan MD, Retired Professor of Orthopedic and Neurological Surgery, New York Upstate Medical University

Spinal Stabilization Technologies will launch in several markets in September

SST will launch the PerQdisc Nucleus Replacement System in September 2021 in markets that recognize the CE mark as their regulatory approval system. Mr. Novotny said. “We have identified 10 centers to launch. They are in Europe, Asia and the Middle East.”

Conclusion

“In the area of degenerative disc disease, the artificial nucleus replacement approach is a truly revolutionary thing,” Dr. Yuan said. “This is an advancement in the options surgeons now have and It will truly maintain a patient’s function, with no consequences or other associated problems. This is almost like getting the silver chalice. It is what we all have been looking for to treat lumbar discogenic pain.”

For more information about Spinal Stabilization Technologies and the PerQdisc Nucleus Replacement System, please visit https://www.sstspine.com.

This article was sponsored by Spinal Stabilization Technologies.

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