When we last wrote about Ron Sacher and the TOPS (Total Posterior Spine System) facet arthroplasty system, we called Sacher one of the “Last Men Standing” in the heady lumbar disc replacement space.
That was in 2017.
Now, Sacher is breaking out from the crowd with the March 31, 2021 announcement that the TOPS system has received Breakthrough Device Designation from the FDA. That means the agency believes that TOPS has the potential to provide a “more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”
It also means a lot more FDA staff time and assistance as Sacher’s Israeli-based company, Premia Spine, prepares to submit its PMA (premarket application) application, AND guarantees national coverage from the Centers for Medicare & Medicaid Services (CMS) for the first four years after market clearance.
TOPS Breaking Through
The TOPS design is unique. 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. According to the company, TOPS is the first and only facet joint replacement system for the lumbar spine. The company expects to submit PMA application sometime in 2021 with the help of Janice Hogan of Hogan Lovells.
This breakthrough designation comes during the company’s second pivotal clinical trial under an investigational device exemption (IDE) from the FDA. In 2017 the company announced the current IDE study to take place in 30 institutions and enroll 330 subjects. Patients were to be randomized to either the TOPS System or lumbar fusion.
Sacher told us then his sense was that the FDA wanted to have spinal stenosis patients treated with non-instrumented surgery or maximum, a coflex. “For the more severe patients with degenerative spondylolisthesis and spinal stenosis—where there is a need for a more thorough decompression and segmental restabilization—an instrumented fusion is warranted. And that’s where we fit in.”
The first TOPS surgery was performed by Luiz Pimenta, M.D., in 2005 in Brazil. Pimenta presented the first TOPS outcomes at the Spine Arthroplasty Society Meeting in Berlin in 2007.
Lumbar Arthroplasty
Lumbar arthroplasty was once considered the most innovative and exciting development in spine surgery. The devices had demonstrated in thousands of patients in Europe an ability to relieve pain while preserving motion in the lumbar spine. The rush was on.
In 2003 DePuy Spine paid $325 million for Charité, while Synthes-Stratec (now owned by DePuy) paid $350 million to Spine Solutions for ProDisc. Then came Maverick (Medtronic) and Flexicore (SpineCore/Stryker).
Posterior and facet replacement devices like Total Facet Arthroplasty System (TFAS–Archus Orthopedics), ACADIA (Facet Solutions) and TOPS (Impliant) had amassed over $150 million to take on posterior pathologies such as facet arthrosis, spondylolisthesis and spinal stenosis with their motion preservation solutions. Sacher was one of the original executives at Impliant.
But insurers balked at paying and the market dried up.
Sacher, Impliant and Premia Spine
Impliant was founded in 1999.
Sacher, a graduate of Harvard (MBA and MPA) and Wharton (BSc), became CEO in 2001 and guided the company through the initiation of the original TOPS IDE 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.
Breakthrough Device Designation Program
To qualify for the FDA designation program, sponsors need to meet two criteria.
First, the device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
Second, the device meets at least one of the following: breakthrough technology, no approved or cleared alternatives exist, offers significant advantages over existing approved or cleared products, and device availability is in the best interest of patients.
You can learn more about the program in Sections II and IV of the Breakthrough Devices Program final guidance.
Sacher said the company is gratified “the FDA recognizes TOPS’s potential to advance the standard of care for patients with spinal stenosis and spondylolisthesis.”
Dom Coric, M.D., chief of neurosurgery at Carolinas Medical Center in Charlotte, North Carolina, and lead investigator in the U.S. pivotal trial added TOPS has the potential “to fill a void in our treatment armamentarium for spinal stenosis and spondylolisthesis. If the results of the pivotal study mirror those found in early clinical trials, TOPS could be a game changer for surgeons and their patients.”
While Ron Sacher and TOPS aren’t only still standing, they are now breaking through.
