Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System
Overview
About the Device
Physicians may prescribe a bone growth stimulator to increase the probability of achieving a successful spinal fusion. The Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System is a class III, FDA-approved, non-surgical, electrical bone growth stimulation device designed as an adjunctive therapy to support healing following spinal fusion surgery. Powered by Capacitive Coupling (CC) technology, the SpinalPak® stimulator delivers targeted therapeutic treatment directly to the fusion site, stimulating the body’s natural bone healing process while reducing the risk of a failed fusion.
Patients recovering from spinal fusion surgery can benefit from the SpinalPak® stimulator’s convenient home-based treatment, promoting effective post-operative spinal fusion healing outcomes.
Features & Benefits
Small, non-surgical device encourages patients to treat discreetly on the go
Lightweight and versatile design optimizes patient comfort and wearability
Soft-Touch® electrodes optimize precise stimulation, penetrating evenly across the treatment site
Powered by pre-clinically proven Capacitive Coupling technology
Clinically proven improved clinical outcomes
How the SpinalPak® Stimulator Works
The SpinalPak® stimulator delivers safe and clinically proven capacitive coupling stimulation through a pair of Soft-Touch® electrodes. The Soft-Touch® electrodes are placed four to six inches apart; approximately 2-3 inches on each side of the fusion site. The area surrounding the electrodes is stimulated inducing the body’s natural healing mechanisms to safely and effectively promote bone growth at the targeted fusion site.
How to Use the SpinalPak® Stimulator
The SpinalPak® stimulator is simple to set up and easy to use.
Clinical Effectiveness & FDA Approval
The SpinalPak® stimulator is supported by pre-clinical research and published clinical studies demonstrating its safety and effectiveness in improving spinal fusion outcomes.
The SpinalPak® stimulator has demonstrated an overall (clinical and radiographic) success rate of 85%.1
Device Specifications
Technology: Capacitive Coupling (CC)
Original FDA Approval Date: 1999
Signal: 60kHz sinusoidal wave
Delivery Method: Soft-Touch® electrodes
Device Weight: 3.15 oz.
Is the SpinalPak® Stimulator Right for You?
The SpinalPak® Stimulator is ideal for patients recovering from spinal fusion surgery.
The device requires a prescription and is designed for patients that could benefit from non-surgical adjunctive treatment to support spinal fusion healing.
Frequently Asked Questions
INDICATION
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® stimulator 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 – Not for Re-Sale or Re-Distribution – Do Not Reuse.
CONTRAINDICATIONS
There are no known contraindications regarding the use of the SpinalPak® stimulator.
WARNINGS
The concomitant use of the device and a pacemaker or cardioverter must be assessed on an individual basis, such as with an electrocardiogram, prior to use. The patient should be referred to a cardiologist for monitoring of pacemaker function while wearing the active SpinalPak® stimulator. If there are any observable adverse changes in the pacemaker rhythm or output, the device should not be used.
The safety and effectiveness of the SpinalPak® stimulator in pregnant women have not been studied, and the effects of the device on the mother or the developing fetus are unknown. A patient who is either pregnant or is intending to become pregnant should be referred to her doctor prior to treatment with the device.
PRECAUTIONS
The SpinalPak® stimulator has not been studied in individuals with the following conditions: spondylitis, infection, Paget’s disease, cancer, diabetes mellitus, renal disease, trauma of the lumbar spine and osteoporosis: therefore, the safety and effectiveness of the device in these individuals is unknown.
PATIENTS
If you have additional questions regarding your doctor’s instructions in using this device, or you are experiencing any type of adverse reaction with the use of this device, contact your doctor immediately. For further product information, refer to the Patient Manual PN1067796-00 or contact EBI® Customer Care at 800-526-2579.
References:
- 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.