• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to footer
  • MANUFACTURERS
  • HEADHUNTERS
  • PRODUCT SECTIONS
  • COMPANIES

SPINEMarketGroup

Spine Industry News

  • HOME
  • 2025
  • 2024
  • BROCHURES
  • ARTICLES
  • VIDEOS

Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis

July 17, 2020 By SPINEMarketGroup

SAN CARLOS, Calif., July 16, 2020 /PRNewswire/ — Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in its U.S. IDE trial studying the use of LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis.  The trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression surgery.  The trial reached its target of 135 LimiFlex patients enrolled into the investigational arm of the trial in December 2019 and the control arm has achieved its target of 160 patients.  To date, a total of 168 study subjects have reached 12 months follow up.  The results of the LimiFlex trial will form the basis for a PMA application to the U.S. Food and Drug Administration (FDA), anticipated by the end of 2021. 

“As we reach this major milestone, our thanks go out to the fantastic partners who have joined us in the LimiFlex trial,” said Richard Treadwell, CEO of Empirical Spine. “We recognize and appreciate the hard work and dedication of the surgeon investigators and research coordinators, as well as the enthusiasm of the patients in participating in this investigation of a non-fusion alternative for degenerative spondylolisthesis.  We would also like to thank our review team at FDA for the collaborative process that has allowed us to complete study enrollment with minimal impacts to the PMA submission timing from COVID-19 disruptions.”

Co-primary investigator Rick Sasso, MD, of the Indiana Spine Group commented, “My experience with LimiFlex has been very positive.  The device may offer a minimally invasive way to stabilize the spine yet preserve motion.  Many patients are extremely interested in less invasive stabilization options that avoid the complications of fusion, so they are attracted to LimiFlex.” 

William Welch, MD of the University of Pennsylvania and co-principal investigator of the LimiFlex IDE study added “I am encouraged by the clinical outcomes and results we have seen so far in the study.  LimiFlex is an exciting new possibility for patients currently undergoing fusion for degenerative spondylolisthesis and would offer much faster recovery for patients, significant savings for payors and more surgical offerings for spine surgeons.” 

Traditional means of stabilizing the spine after decompression surgery involve lengthy, invasive procedures that use bone graft material, combined with instrumentation such as pedicle screws and rods, to fuse two or more vertebrae together.  The resulting constructs reduce spinal flexibility and magnify the forces experienced by adjacent levels, often leading to accelerated degeneration of the adjacent spinal segments.  While the acute clinical outcomes may be excellent, this accelerated degeneration can lead to longer term issues, sometimes requiring additional surgery.

Occasionally, patients with this instability diagnosis forego stabilization in favor of standalone decompression surgery, which carries a high risk of recurrence and reoperation due to progressive instability.

The LimiFlex was developed as a way of bridging this therapy gap by offering a minimally invasive way to stabilize the spine yet preserve motion.  The device aims to restore the spine’s natural biomechanics, along parameters such as stiffness, lordosis, and facet engagement.

The LimiFlex IDE trial is a prospective, multi-center, controlled clinical trial studying the safety and efficacy of the LimiFlex Paraspinous Tension Band compared to TLIF in patients suffering from degenerative spondylolisthesis and lumbar spinal stenosis.  The study endpoint is the rate of overall clinical success at 24 months. The goal is to show that patients can achieve fusion-equivalent results – without the fusion.

The device received the CE mark in 2009 and has been implanted with excellent results in over 2,000 European patients.

About LimiFlex

The LimiFlex Paraspinous Tension Band is a new, investigational device designed as an alternative to spinal fusion for patients receiving surgical decompression for grade 1 lumbar degenerative spondylolisthesis with spinal stenosis.  LimiFlex does not involve any screws or bone grafts, which eliminate the natural motion between spine segments.  Instead, LimiFlex is designed to stabilize the spine without fusing it, thereby preserving motion. The device works by supporting and enhancing the spine’s natural biomechanics with stabilizing yet flexible elements.  The LimiFlex device is placed following a standard decompression surgery, typically in less than 20 minutes.

About Empirical Spine

Empirical Spine, Inc.,  is a privately held company developing advanced solutions for the surgical treatment of spinal disorders.  The company is currently running a pivotal IDE trial in the US on its motion-preserving Paraspinous Tension Band, LimiFlex.  LimiFlex is a minimally invasive implant that is designed to stabilize the spine after decompression surgery yet preserve motion.

Caution: The LimiFlex Paraspinous Tension Band is an investigational device in the United States and is limited by law to investigational use.

SOURCE Empirical Spine

(Visited 2 times, 1 visits today)

Filed Under: NEWS Tagged With: 2020, NEWS

Primary Sidebar

PLATINUM SPONSORS

GOLD SPONSORS

MOST POPULAR POSTS

  • BROCHURES
  • Just Reflective, Not Disappointed: Globus Medical’s…
  • What’s Happening with Globus Medical? Why Has the…
  • (UPDATED 2025): 6 Artificial Cervical Discs You’ll…
  • (UPDATED 2024): +8 Lumbar Artificial Discs to Know…
  • Stryker’s Spine Business Sale: A Smart Move or a…
  • Globus Medical to Execute $500 Million Share Buyback…
  • Globus Medical extends versatility of Advanced…
  • The Crown Is Still Medtronic’s… For Now!
  • Eminent Spine’s 3D Printed Titanium Pedicle Screw…
  • Dispute Over Spinal Implant Royalties Between…
  • M6 Discontinued: What Are the Alternatives for a…
  • Orthofix Discontinues M6-C™ and M6-L™ Artificial…
  • Alphatec Today: Where It Stands and Where It’s Heading?
  • (Updated!) 15 Expandable PLIF Cages to Know…!
  • (UPDATED 2024): +108 Stand-Alone Cervical Cages to Know..!
  • Stryker’s Spine Exit: What It Means for…
  • Why Didn’t Globus Medical’s Stock Rise After…
  • Globus Medical Reports First Quarter 2025 Results
  • Viscogliosi Brothers Completes Acquisition of U.S.…
  • LAST 10 VIDEOS PUBLISHED

    1. Biedermann Motech: MOSS 100 (Short)
    2. POWEHI MEDICAL AG: KUDOS™ Modular
    3. POWEHI MEDICAL AG: TANTO® Screw
    4. Syntropiq: Taurus TLIF (Short)
    5. LEM Surgical: Dynamis Surgical Robot
    6. Aegis Spine:PathLoc-TA
    7. NGMedical: MOVE®-C Artificial Disc
    8. B.Braun Aesculap: Ennovate® Cervical MIS
    9. Spineart: PERLA® TL Deformity Solutions
    10. NGMedical: MOVE®-C

    Recent Comments

    • Peter on A New Player in Spinal Care, POWEHI Medical!
    • Sandy on Just Reflective, Not Disappointed: Globus Medical’s Bittersweet Q1 2025
    • SPINEMarketGroup on M6 Discontinued: What Are the Alternatives for a Cervical Artificial Disc?
    • Sergio López-Fombona on M6 Discontinued: What Are the Alternatives for a Cervical Artificial Disc?
    • Drew on Has Globus Already Surpassed Medtronic in the Spine Market? Can J&J Find Its Way Back to the Top?
    • Ahmed Hassan El-Naggary on Has Globus Already Surpassed Medtronic in the Spine Market? Can J&J Find Its Way Back to the Top?
    • Email
    • Twitter
    • YouTube

    Subscribe to Our Newsletter!

    Check your inbox or spam folder to confirm your subscription.

    Footer

    • Email
    • Twitter
    • YouTube

    Contact us:

    [email protected] [email protected]

    PRIVATE POLICY

    • Legal Advice
    • Embed Link
    • VIDEOS

    Copyright © 2025 · SPINEMarketGroup

    Manage Cookie Consent
    To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
    Functional Always active
    The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
    Preferences
    The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
    Statistics
    The technical storage or access that is used exclusively for statistical purposes. The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
    Marketing
    The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.
    Manage options Manage services Manage {vendor_count} vendors Read more about these purposes
    View preferences
    {title} {title} {title}