Overview:
In a major announcement, the FDA has approved for commercial sale in the United States the TOPS™ motion-preserving facet replacement system.
In a major announcement, the FDA has approved for commercial sale in the United States the TOPS™ motion-preserving facet replacement system.
Quoting directly from the June 15, 2023, approval letter: “The TOPS™ System is intended to stabilize the spine following a lumbar decompression without rigid fixation. The TOPS™ System is indicated for patients between 35 and 80 years of age with symptomatic degenerative spondylolisthesis up to Grade I, with moderate to severe lumbar spinal stenosis and either the thickening of the ligamentum flavum and/or scarring of the facet joint capsule at one level from L3 to L5.”
The manufacturer, Premia Spine and its CEO, Ron Sacher, have been working on this for 20 years—since 2003.
Yet…incredibly…TOPS will quite likely be a game changer in spine surgery.
Game Changer for Both Surgeons and Patients
Dom Coric, M.D., from Carolina Neurosurgery and Spine Associates and Spine First Atrium Health in Charlotte, North Carolina, and lead investigator in the TOPS U.S. pivotal trial told OTW in 2021 that TOPS “fills a void in our treatment armamentarium for spinal stenosis and spondylolisthesis,” and that it promised to be “a game changer for surgeons and their patients.”
Advancing the Standard of Care
Prior to its June 15, 2023 approval, TOPS had qualified for the FDA’s Breakthrough Device Designation program, which meant that, in the FDA’s judgment:
- TOPS could be a more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
- TOPS was a breakthrough technology for which no approved or cleared alternatives existed and yet it offered significant advantages over existing approved or cleared products.
In short, even before its approval, TOPS was considered to be an implant likely to advance the standard of care for patients with spinal stenosis and spondylolisthesis.”
The TOPS Breakthrough Design
The TOPS design is unique.
It is a vertebral implant with a polymer cushion to allow motion and shock absorption. The device has four crossbars which flare out and anchor the implant to polyaxial pedicle screws. TOPS is the first and only facet joint replacement system for the lumbar spine.
The first TOPS surgery was performed by Luiz Pimenta, M.D., in 2005 in Brazil. Dr. Pimenta presented the initial TOPS outcomes at the Spine Arthroplasty Society Meeting in Berlin in 2007.
Fast forward to 2017 when the second-generation TOPS device initiated its IDE [investigational device exemption] study in the United States after completing clinical testing in the UK, Israel, Austria, and Germany.
The new TOPS indication was Grade I degenerative spondylolisthesis and severe spinal stenosis patients, where there is a need for a very thorough decompression and segmental re-stabilization. TOPS found its sweet spot—going up against instrumented TLIF [transforaminal lumbar interbody fusion] fusion—the gold standard.
Spoiler alert: TOPS established, in its FDA clinical trial, head-to-head clinical superiority over TLIF. And will be so labeled, per the FDA.
The FDA study took place at 37 institutions in the United States and enrolled 302 subjects. Patients were randomized 2:1 to either the TOPS System or TLIF lumbar fusion.
The Clinical Study Results
Late 2022, the Journal of Neurosurgery Spine published interim results from the TOPS IDE study that generated a significant amount of interest among spine and neurosurgeons.
A total of 249 patients from all available follow-up time points were evaluated—170 in the TOPS group and 79 in the TLIF group. The percentage of patients reporting a minimum 15-point improvement in ODI [Oswestry Disability Index] showed a statistically significant difference in favor of TOPS (93%) over TLIF (81%).
The percentage of patients reporting a minimum 20-point improvement in VAS [Visual Analog Scale] back pain favored TOPS (87%) versus fusion (64%) and had equally good leg pain score outcomes (TOPS, 90%; TLIF, 88%).
The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°).
Dr. Coric, the author of the paper and Principal Investigator of the IDE study explained that “with the TOPS System, you have a situation where the nerves are free and therefore the patients have done well. You maintain motion, which is a more natural phenomenon. Furthermore, we’re not placing additional stress at the adjacent levels.”
“It’s a win-win situation, and that’s what the results of the study bore out: The patients that had decompression and motion preserving facet replacement did better than patients who had decompression and stabilization with the fusion.”
From time to time, other individual clinical sites have published their case studies for the TOPS system in peer-reviewed journals.
In the July 22, 2022, edition of Operative Neurosurgery, results from a European study by Werner Lack, M.D. in Vienna, Austria (Arbeitsgemeinschaft Freier Wirbelsäulenchirurgen) were published. “Mobility-Maintaining Facet Arthroplasty of the Lumbar Spine With the Second-Generation TOPS System: A Case Series.”
Dr. Lack collected data from 17 patients who had been implanted with the TOPS System for 51 months, on average. Dr. Lack’s patients’ pain levels, on a 10-point Visual Analog Scale, fell by 7.5 points at 3 months, 6.8 points at 12 months, and 6.7 points at the longest follow up—an average improvement of 81%.
Preoperative and postoperative average range of motions (ROMs) at the index level were 8.2 degrees and 7.4 degrees, respectively.
Dr. Lack told OTW: “The TOPS facet replacement device maintains not only normal range of motion but also the quality of motion at the index level, while reducing peak stresses on the pedicle screws.”
“It is well documented that when one or more segments are immobilized by a fusion, the stress and demands resulting from regular activity (bending, lifting, etc.) increase at the levels above and below to compensate for the rigid segment. This can accelerate the degenerative cascade. The early randomized clinical outcomes of facet replacement versus fusion demonstrate an early advantage to facet replacement on reduced adjacent segment disease.”
Dr. Lack added that the TOPS device was the first to allow patients to settle into their own natural sagittal balance.
“The TOPS device does not ‘create’ motion. Nor does it off-load the spine. Rather, the device is there to constrain motion and share the body’s load with the anterior disc.”
“In the native spine, it is the disc that carries most of our load, while the facet joints are there to constrain the motion and thus protect our nerve roots and the central canal. Inside the facet replacement device we used are a series of sophisticated stoppers that recreate the function of the facet joint; namely, to provide constrained motion in flexion, extension, lateral bending, axial rotation, and sagittal translation.”
“Therefore, once the decompression of the diseased native facets is performed and the segment is released, the spine will naturally settle into its preferred (and now less painful) position as the patient returns to normal activities.”
“I want to tell other surgeons that, in our experience, we found, for the first time, an implant which for the right indications (e.g., spondylolisthesis, stenosis) can restore the mobility of the spinal segment with a good lordosis and therefore can prevent or at least delay adjacent disc disease,” Dr. Lack told OTW.
A Short History of TOPS and Its Champion: Ron Sacher
TOPS began development 20 years ago at a small Israeli start-up named Impliant.
Ron Sacher, a graduate of Harvard (MBA and MPA) and Wharton (BSc), became Impliant’s CEO in 2001 and guided the company through the design, methodology, and implementation of the original TOPS IDE study.
Sacher left Impliant in 2007 to start two other medical device companies which he sold to Boston Scientific and Spectranetics, respectively—amazingly, in just three years, all in.
While Sacher was gone, Impliant hit two insurmountable challenges—a longer and more complex than expected regulatory pathway and, the coup de grace, a financial recession in 2008-2009.
By June 2010, Impliant shut down. Sacher had just sold his second company. Well aware of Impliant’s struggles—Sacher also understood the potential value of the TOPS System for building an eventual business.
Putting his own money on the line in March 2011, Sacher returned to Impliant, renamed the company Premia Spine, and began the process of upgrading the TOPS design (smaller, easier to implant), recruiting a group of private investors who provided over $90 million in financing, building a real business in Europe, Israel, and Asia, and reviving the TOPS clinical study in the United States—aiming for eventual FDA PMA [Pre-Market Approval].
On-Label Superiority Over TLIF
Last week, Premia Spine announced not only PMA approval, but also that the pivotal FDA study data revealed that the TOPS arthroplasty group significantly surpassed the TLIF fusion group in overall clinical success, with a 77% success rate compared to 24% for fusion arm, garnering for the TOPS System a coveted superiority label to fusion.
TOPS is now the first and only lumbar spine device to gain a superiority claim to fusion from the FDA.
The new TOPS device has been implanted for more than 11 years throughout Asia and Europe. Premia Spine, selling a range of products in Europe, Asia, and the U.S., is financially stable—and the game changing TOPS System is approved for sale in the biggest spine market in the world—the United States of America.
Videos and More
Here are links to three excellent Master Class videos which RRY Publications produced along with Premia Spine: https://youtu.be/FJZtJFY_uYs https://youtu.be/5dlX5xGLKIQ https://youtu.be/p7udVQsnE0U
