New implant is alternative to spinal fusion

Israel’s Premia Spine has a transformative solution for spinal stenosis inspired by the success of total hip and total knee replacement.

One of the most common causes of back pain is spinal stenosis of the lower back – a narrowing of the spinal canal that causes pressure on the spinal cord and nerve roots. Fixing the problem usually involves spinal fusion, an operation to permanently join two or more vertebrae bones so there is no movement between them.

It’s hardly an ideal solution.

The Israeli company Premia Spine is offering a unique and – it believes – better option. Its trademarked TOPS (Total Posterior Solution) System aims to revolutionize the spinal implant market in the same way that total hip and total knee replacement systems made hip and knee fusions a thing of the past.

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“We believe patients suffering from spinal stenosis can also get joint replacement rather than fusion,” CEO Ron Sacher tells ISRAEL21c. “We’ve developed an implant that recreates all functions of the posterior spinal column, where there are important joints, ligaments and bony structures that provide control over twisting, bending and flexing.”

TOPS allows the surgeon to remove diseased parts of the spine and then stabilize it with an artificial joint that restores the function of a normal posterior spinal column.

The titanium-sandwiched implant not only gives patients normal, pain-free mobility, but it also protects adjacent levels of the spine from similar degeneration – a common unwanted side effect of fusion surgery.

Already having earned the European Union’s CE Mark, TOPS is available to patients in Austria, Germany, the UK, Turkey and Israel. This year, the company’s European marketing efforts will expand, says Sacher.

In addition, Premia Spine will assume sponsorship of a US Food & Drug Administration study that has been collecting data on patients who had the device implanted experimentally as many as five years ago.

Improved results

The TOPS implant allows for full range of normal back motion.
The TOPS implant allows for full range of normal back motion.

The TOPS System originated at the Israeli orthopedic device company Impliant, which Sacher joined as CEO in 2001. Two years later, the firm hired design engineer Uri Arnin, whose groundbreaking ApiFix device for correcting curvature of the spine is now in clinical trials.

“At that time, we decided to transition from classic orthopedics to spinal implants,” says Sacher, who holds two Ivy League business degrees.

After ascertaining that the most frequent spinal disease in people over 40 is spinal stenosis, he relates, “We saw a need for better clinical outcomes than fusion surgery, and thought that our experience and knowledge could be leveraged to make significant improvements.”

Impliant invested more than $50 million in perfecting the TOPS implant, its instrumentation, and the surgical technique.

Though Sacher left Impliant in 2007 to co-found another medical device company he later sold to Boston Scientific, in 2011 he acquired the TOPS System’s 16 worldwide patents, and restarted the company as Premia Spine. It’s still based in Ramat Poleg, near Netanya.

He explains that the TOPS System is intended for adult patients with disease affecting the three segments of the lower, or lumbar, region of the spine when non-surgical treatments have failed to provide relief. “The device comes in different sizes to cover the range of anatomies that exist,” Sacher adds.

For patients whose stage of disease is so severe that they cannot be helped by TOPS alone, Premia Spine also manufactures and sells a trademarked fixation system to be used in fusion surgery, which can be “topped off” with a TOPS implant.

“Usually spinal disease starts at the base of the lower back and works its way up, so you can have a more diseased state at one level and a less diseased state adjacently. TOPS can be placed above the fusion to serve as a transitional segment to protect the spine levels above it,” says Sacher.

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About Abigail Klein Leichman

Abigail Klein Leichman is a writer and associate editor at ISRAEL21c. Prior to moving to Israel in 2007, she was a specialty writer and copy editor at a daily newspaper in New Jersey and has freelanced for a variety of newspapers and periodicals since 1984.
  • juliusmc

    is it available in Asia, in the Philippines in particular? how much would be the cost?

    • Amy Friedkin

      It is best to contact Premia Spine directly… they have a special section for Patients and a contact form on their website.

      Good luck!

  • venom911

    Instead of different sizes, why don’t they just print the exact size for the patient? Yes they do titanium printing. They did it for a jaw bone

  • Pam Whaley Denham

    I need this! My back has ‘natually’ fused and somehow has broken in one place. I am NOT a surgical candidate as I have osteoporosis and degenertive disc disease. I’ve had my neck fused in 1990 and did not have the hardware removed. My problem lies in my lumbar region and no one wants to touch me. I am 60 yrs. old and an active person.this problem has put me on pain killing meds which after so many years, have no real effect on the agonizing pain.I also am a small person,5′ and 110 lbs. before this , I practiced martial arts and exercised regularly.Now, well ,as you can surmise, this cannot happen and I’ve become depressed. My Dr. (family care) is wonderful, and I truly love him for all his understanding and compassion, which is hard to find in a DR these days! Any feedback?

  • Lubicz Stephane

    Who in the US has experience with this device?

    • Vika Marina-Williams

      Nobody. Not FDA cleared.

  • Sandra Wepking Spinniken

    This is so exciting !

  • Mike Doyle

    There are many therapies but the reason why people chose prefer the alternative therapies is because of the reduced side effects and after treatment pain.

  • Arjen van Geffen

    Sounds promising. Will this work for thoracic kyphosis as well?

  • Corinna Murfet

    Is this available in Australia .?

  • Vika Marina-Williams

    consult ur doctors…

  • jesskazen

    please get this to the US

  • siorasurgicals

    This is good news for health industry but check the success ratio.

    • Joe Shock

      What is the success ratio then. Sounds like you might know? or Joe Shock, Holcombe, WI. on Facebook. Having fusion surgery the 14th of April.

  • Joe Shock

    Kurtis Dafford is a surgeon doing this procedure at Beth Israel Deaconee Hospital in Pllymouth, Massachusette.