Once upon a time lumbar arthroplasty was the most innovative and exciting development in spine surgery.
The devices, which had been implanted in thousands of patients in Europe, had demonstrated an ability to relieve pain while preserving motion in the lumbar spine.
Motion preservation, it was thought, would lower the risk of adjacent segment disease and improve long-term spine patient outcomes.
Given time and some design and surgical technique tweaks, most experts predicted that motion preserving spinal implants would transform spine surgery.
And the dollars flowed.
Johnson & Johnson’s DePuy Spine paid $325 million to Waldemar Link for Charité in 2003. Earlier that same year Synthes-Stratec (now owned by DePuy) paid $350 million to Spine Solutions for ProDisc. Coming up behind Charité and ProDisc were Maverick (Medtronic) and Flexicore (SpineCore/Stryker).
Posterior and facet replacement devices like TFAS (Archus Orthopedics), ACADIA (Facet Solutions) and TOPS (Impliant— Total Posterior Spine System) had amassed over $150 million to take on posterior pathologies such as facet arthrosis, spondylolisthesis and spinal stenosis with their motion preservation solutions.
Then everything collapsed.
Eight months after the FDA approved Charité, most private insurers refused to cover the cost of the procedure, which was about $30,000 to $45,000 for a single disc. While Medicare did provide some coverage, it paid out far less than the $11,500 that DePuy charged for its artificial disc—although DePuy did offer the Charité at discounts of as much as 20% to its high-volume customers.
No reimbursement, no lumbar total disc replacement (TDR).
Of that initial group of pioneering lumbar artificial discs only one is still on the market today—ProDisc L—and none are in clinical testing.
Until now.
TOPS
This year, March 2017 to be exact, the FDA gave one of the original lumbar arthroplasty designs, the new TOPS™ System, approval to start a new clinical study in the U.S.
Leading the charge is none other than the original executive behind Impliant’s TOPS, Ron Sacher and his company, Premia Spine, based in Herzeila, Israel..
It’ll be the second time TOPS has started a clinical study in the U.S.
This time 30 sites and some of the top spine surgeon/scientists in the country have signed on. This will almost certainly be one of the most watched studies in years.
The TOPS design is unique. As the images show, it is a vertebral implant with a polymer cushion to allow motion and shock absorption. The device also has four crossbars which flare out and anchor the implant to polyaxial pedicle screws.
Spine surgeons can implant TOPS by way of the traditional posterior approach.
The system is designed to deliver motion preservation, decompression, stability and pain relief for patients with a grade I degenerative spondylolisthesis and spinal stenosis.
Will TOPS succeed where so many others have failed?
For Ron Sacher the second time around may well be the charm. If so, his TOPS will join ProDisc and Aesculap’s activL as the only lumbar arthroplasty systems available in the U.S. and be one of the last two men standing from those halcyon motion preservation days.
Lumbar TDR’s Tortuous Path to Market
Incredibly, it’s been 57 years since the first artificial disc was implanted in 1960.
That was the Fernström steel ball, implanted using an anterior approach. Rumor has it President John F. Kennedy was a Fernström ball patient. Initial results were encouraging but longer term the ball often subsided into the subchondral bone.
Thirty-three years ago (1984) Schellnack and Büttner-Janz implanted the SB Charité using the anterior approach. The implant was a semi-constrained type of lumbar artificial disc (LAD) comprised of two metallic upper and lower plates and a sliding polyethylene core.
Over the years, three upgraded designs of the Charité were launched.
Twenty-seven years ago (1990) Marnay implanted ProDisc-L in France, which was a semi-constrained TDR with two metal plates and a non-mobile polyethylene core.
The ProDisc-II was launched in 1999 and is probably the most widely used artificial disc in the world. Many, many different designs and compositions of LAD have been launched but only three ever made it through the FDA gauntlet.
The three lumbar intervertebral disc prostheses approved by the FDA for surgical implantation within the spine for single-level disc replacement are:
- The Charité® Artificial Disc (pulled from the market by DePuy Spine, Inc.)
- The ProDisc®-L Lumbar (DePuy Synthes)
- activL® Artificial Disc (Aesculap Implant Systems, LLC, approved by the FDA in 2015).
Only ProDisc®-L and activL are available for sale in the U.S.
The TOPS Study
The first patient of the new study is likely to receive their very own TOPS in mid-June.
Investigators will be enrolling patients with grade I degenerative spondylolisthesis and spinal stenosis. They will be measuring ODI (Oswestry Disability Index), neurologic function, reoperation rates and function for TOPS versus lumbar fusion (i.e., an interbody cage plus screws and rods).
The plan is to recruit 330 patients in a 2:1 randomization protocol.
Premia will be working with 30 of the top spine centers in the United States. The study’s lead investigator is Domagoj Coric, M.D., Chief of Neurosurgery, Carolinas Medical Center.
Impliant’s Story
Impliant was founded in 1999.
Ron Sacher, a graduate of Harvard (MBA and MPA) and Wharton (BSc), became CEO in 2001 and guided the company through the motion preservation boom and the initiation of the original TOPS IDE [investigational device exemption] study. He left Impliant in 2007. In 2010, he was approached to take over the project when Impliant was closing its doors. He completed the purchase of Impliant’s assets in March 2011.
The first TOPS surgery occurred in 2005 in Brazil. It was performed by Luiz Pimenta, M.D., who presented the first TOPS outcomes at the Spine Arthroplasty Society Meeting in Berlin in 2007.
He reported that the TOPS patients experienced a 40-point improvement in the Oswestry Disability Index (57 to 17 at two-years), a 64-point improvement in Visual Analog Scale (84 to 20 at two-years), and a 36-point improvement in the Zurich Claudication Score (58 to 22 at two-years).
After Brazil, the TOPS device went to Europe. John Sutcliffe, MBChB, FRCS(Ed), FRCS (SN), at the London Spine Clinic in London, England, studied the TOPS device and presented at the 2012 International Society for the Advancement of Spine Surgery (ISASS) meeting in Barcelona on a dozen patients who all had a maximum post-op ODI of 12%. “I was impressed with the simplicity of the system. Implantation was very easy and straightforward,” he said at the time. Mr. Sutcliffe’s comments were echoed by Robert Hes, M.D., and Bart Conix, M.D., who together performed the TOPS surgeries at the Middelheim Hospital in Antwerp, Belgium. “It is a very elegant system,” they said.
The TOPS U.S. IDE study was launched in 2006. In 2007 the study was stopped when one of the TOPS devices failed. TOPS was redesigned and the IDE was restarted. The study was moving forward in 2008 through 2010 with good progress.
But Impliant was running out of money. As with Archus Orthopedics and Facet Solutions, the financial crisis had taken its toll on its investors and the early-stage, TDR-sized exits had disappeared. With no buyer in sight and in the middle of its FDA trial, Impliant shut its doors in the summer of 2010.
Premia Spine Buys Impliant’s Assets
After Impliant, Ron Sacher co-started and then sold two companies in the peripheral vascular space to Boston Scientific and Spectranetics.
But he never forgot Impliant and TOPS.
In March 2011 Ron founded Premia Spine Ltd in order to buy Impliant’s assets, including its IP, core technology and manufacturing plant.
In September 2011 Ron and a small group of high net-worth, private investors put up the capital and launched a redesign of the TOPS to make it significantly smaller and simpler to implant.
In 2012, following the redesign, TOPS, which has CE Mark, started selling in Europe.
In parallel with the European launch, Ron and his team at Premia completed a follow-up study on patients in the original U.S. IDE study.
The data, they saw, was outstanding. Six U.S. centers from the original IDE study received IRB (Institutional Review Board) approval to bring back their patients for follow-up. They applied the traditional composite patient success metric:
- ODI improvement of at least 15%
- Maintenance or improvement in neurological status
- No radiographic device failure
- No radiographic screw loosening
- Radiographic absence (TOPS) or presence (Control) of fusion
- Freedom from additional surgical intervention defined as revision, non-elective removal or supplemental fixation
In their 23 TOPS patients and 23 posterolateral fusion patients at two years and beyond, they found an 86% success rate in the TOPS arm of the study and a 64% success rate in the fusion arm.
TOPS Is Back In a New Payment World
So the new smaller TOPS has been relaunched, and TOPS has been used worldwide in over 1,000 surgeries.
But where does TOPS fit in this new era of bundling, pricing pressures and a very fluid healthcare environment?
The original promise of motion preservation was to improve long term outcomes for severe leg and back pain patients. Using the current healthcare lexicon that should translate into lower readmission rates, fewer follow up office visits and fewer pain meds.
TOPS, and all total disc replacement implants, need to, in effect, pay for themselves in the form of better outcomes and lower costs in the current cost containment environment.
No one knows this better than Ron and his team—which is why the new TOPS study will be one of the most watched spine studies in a long time. Stay tuned.
Unless otherwise indicated, images are courtesy of Premia Spine Ltd.
