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SPINALPAK®

NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

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When spinal fusion patients present with specific medical conditions or co-morbidites that may compromise normal healing of their spinal fusion, an electrical bone growth stimulator may be prescribed like the Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System which is a proven, adjunctive solution to aid in their healing process.

 

The SpinalPak is an innovative, small, lightweight, easy-to-use, non-invasive, FDA approved spinal fusion stimulation device that helps aid in the healing of spinal fusions. It’s lightweight electrodes weigh less than an ounce, allowing for minimal weight around the fusion site, and provides patients with a unique solution that can be comfortably worn under a brace.

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The SpinalPak is powered by capacitive coupling (CC) electrical stimulation technology with proven pre-clinical results and an established clinical safety and efficacy profile. The SpinalPak has been safely and effectively helping people heal for 25 years.

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

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Capacitive Coupling Proven to Upregulate Multiple Bone Morphogenetic Proteins (BMPs) 1*

BMP Expression in Response to Capacitive Coupling Stimulation

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  • The upregulation of multiple 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. 1*

  • While the greatest expression of osteogenic BMPs was observed after 24 hours of CC stimulation, two to three times more upregulation was observed after just 30 minutes of CC stimulation and continued to increase in a dose dependent manner. 1*

Unique intracellular and extracelluar calcium ion activation 2*

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  1. CC Stimulates Voltage Gated Calcium Ion Channels to Allow Calcium Ions to Enter into Cell

  2. Calcium Ions Then Activate Calmodulin (Protein)

  3. Activated Calmodulin Leads to Increased Cell Proliferation

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

Statistically Significant Increase in Cellular Proliferation 2*

  • The capacitive coupling signal produced significant DNA production at each time point up to 24 hours 2*

  • CC produced significantly more DNA production than CMF and PEMF 2*

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

CAPACITIVE COUPLING IS THE ONLY NON-INVASIVE ELECTRICAL STIMULATION TECHNOLOGY RECOMMENDED BY NASS FOR HIGH-RISK PATIENTS UNDERGOING POSTEROLATERAL FUSIONS. 3

Proven, statistically significant clinical outcomes 4

†The patients in the “Degenerative Disc Disease Only” group were patients that were initially diagnosed with DDD and underwent a one-to two-level spinal fusion surgery. In this study, the DDD group only consisted of 52 patients in the SpinalPak treatment group and 54 patients in the placebo group.

 

The overall success rates both clinical and radiographic was 84.7% for active and 64.9% for placebo patients. (P=0.0043).

EBI Bone Growth Stimulation

The Industry leading pioneers

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EBI pioneered the bone growth stimulation market and has been proudly advancing their mission of helping people heal to restore their daily life for 45 years.

 

  • The original bone growth stimulation company

  • Backed by proven science and an established clinical history

  • The only company with three bone growth stimulation technologies

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