Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System

Effective

  • In one clinical study, the SpinalPak stimulator demonstrated healing outcomes as high as 92.7% 1,*,≠
  • For lumbar spinal fusions, overall success rate (clinical and radiographic) was 84.7% in the Spinal Pak group vs. 64.9% in the placebo group (P=0.0043)1
    • In posterolateral fusions, the success rate was 89.1% in the SpinalPak group vs. 64.9% in the placebo group (P=0.006)1

Scientifically Proven

  • In one in vitro pre-clinical study, upregulation of multiple bone morphogenetic proteins (BMPs) was shown to occur with capacitive coupling (CC) stimulation in as little as 30 minutes of exposure with optimal upregulation occurring at 24 hours 2,**
  • In another pre-clinical study, capacitive coupling (CC) stimulation was shown to cause significantly higher levels of cellular proliferation than other electrical stimulation technologies, including combined magnetic fields (CMF) and pulsed electromagnetic fields (PEMF)3,**

An Established Product

  • Nearly 400,000 SpinalPak Stimulator Systems sold4
  • More than 30 years of proven clinical use5

Designed with Patients in Mind

  • Smallest and lightest electrical stimulation device on the market6
    • Lightweight electrodes weigh less than an ounce allowing for minimal weight around the fusion site, and can be comfortably worn under a brace
  • Compliance monitoring software – The SpinalPak stimulator contains embedded software that displays patient treatment data. This data may be downloaded to a health care professional’s computer for reviewing, storage or printout, via the use of the Patient Compliance Data Download Software7

Indications
The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System is a non-invasive spine fusion stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels - P850022/S017.

Usage
The SpinalPak Non-invasive Spine Fusion Stimulator System is designed to deliver 270 days of continuous therapeutic treatment for 24 hours per day. The recommended daily therapeutic treatment is continuous for 24 hours. Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician. Rx Only - Prescription Only - Single Patient Use Only - Do Not Reuse.

Contraindications
There are no known contraindications regarding the use of the Biomet SpinalPak Non-Invasive Spine Fusion Stimulator System.

For complete prescribing information including warnings and precautions, please refer to the Biomet SpinalPak Non-invasive Spine Fusion System Complete Manual and Package Insert or the Patient Manual PN1067795-00 or PN1067796-00 or call 1-800-526-2579 extension 6000.

Financial Disclaimer

In support of their research for or preparation of this work, one or more of the authors may have received remuneration from Zimmer Biomet.

  1. Goodwin CB, Brighton CT, Guyer RD, Johnson JR, Light KI, Yuan HA. A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions. Spine. 1999;24(13):1349-1356.
  2. Wang Z, Clark CC, Brighton CT. Up-regulation of bone morphogenetic proteins in cultured murine bone cells with use of specific electric fields. J Bone Joint Surg Am. 2006;88(5):1053-1065.
  3. Brighton CT, Wang W, Seldes R, Zhang G, Pollack SR. Signal transduction in electrically stimulated bone cells. J Bone Joint Surg Am. 2001;83-A (10):1514-1523.
  4. Data on File at Zimmer Biomet – ZBDATA1_20
  5. Data on File at Zimmer Biomet – P850022
  6. Data on file at Zimmer Biomet – P&R17341A 
  7. Compliance Data Download Software User Manual – PN 1067778-01

 

*Represents the clinical success rate for posterolateral fusion only. Radiological results P=0.0013 and clinical results P=0.008. P values between 0.05 and 0.10 show a trend toward statistical significance.

**Although not indicative of human clinical results, outcomes from pre-clinical research have been implicated in various models of bone repair.

≠The overall success rates (i.e., clinical and radiographic) for the SpinalPak Non-invasive Spinal Fusion Stimulator which led to PMA approval were 79% for the active group vs 61% for the placebo group. The difference in the rates of overall success (18%) was statistically significant (P=0.0018).

Legal Manufacturer:

EBI, LLC d/b/a Zimmer Biomet
Bone Healing Technologies
399 Jefferson Road
Parsippany, NJ 07054 USA


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For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counselling information, see the package insert and information on this website.