When a bone fractures, the body produces naturally developing electric fields surrounding and within the fractured bone segment to stimulate repair. This naturally developing internal electric fields room a crucial biological process necessary because that bone come grow and heal normally.
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The purpose in making use of a bone growth stimulator is to mimic the body’s very own natural developing signaling processes by the application of an external, electrical treatment signal for patients who might be at danger of healing.
The only electrical stimulation an equipment on the industry that is FDA approved for 24-hour use to treat nonunion fractures1
In one in vitro pre-clinical study, upregulation of many bone morphogenetic proteins (BMPs) was shown to take place with capacitive coupling (CC) stimulation in as tiny as 30 minutes the exposure through optimal upregulation arising at 24 hours 2,*
How the Works
The OrthoPak Stimulator device works by sending low level electric impulses directly to the nonunion fracture site via a pair of disposable electrodes. Two lightweight electrodes are placed on either side of the fracture nonunion site and also positioned 180 degrees apart from every other. The stimulator produces an electric treatment signal in the area between the electrodes, which help to mimic the body’s herbal healing process.
Click right here to download a copy that the patient brochures and also manuals i m sorry contain information and also answers to commonly asked questions.
The Biomet OrthoPak Non-invasive Bone expansion Stimulator system is design to provide 270 job of consistent therapeutic therapy for 24 hours per day. The recommended everyday therapeutic treatment is constant for 24 hours. An easy safety precautions should always be followed, including removal that the machine prior come showering, shower or swimming.
Healing outcomes might vary because of health, activity, risk determinants or various other medical problems the patient may have. Not all patients are candidates because that this medical device so it’s necessary to evaluate every patient before prescribing the device. Just a standard health treatment professional have the right to determine the proper treatment because that each patient.
Frequently asked Questions
How have the right to a patience be prescribed one OrthoPak Stimulator System?
A standard healthcare skilled must prescribe the OrthoPak Stimulator System. The OrthoPak is a non-invasive bone development stimulator shown for the therapy of an developed fracture nonunion acquired secondary to trauma, not included vertebrae and all level bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is taken into consideration to be developed when there room no visibly progressive signs that healing.
The patient has actually a pacemaker. Deserve to they it is in prescribed one OrthoPak Stimulator System?
The usage of a pacemaker or cardioverter need to be assessed top top an separation, personal, instance basis. Zimmer Biomet recommends the you speak v a standard healthcare skilled (HCP). This might require consultation v a cardiologist, who deserve to monitor her pacemaker with an electrocardiogram when the patience is wearing the OrthoPak Stimulator System.
can a patient use or be prescribed one OrthoPak Stimulator system while wearing a electronic came walking fracture boot, actors or wrist splint/brace?
Yes, the OrthoPak Stimulator System’s electrodes have the right to be worn comfortably in combination with a boot, wrist splint or brace. Use the electrodes straight to the skin, in ~ the fracture nonunion website with every electrode positioned 180 degrees apart from one another. Once the electrodes space positioned, you can wear the boot, wrist rail or brace together directed by your doctor.
Is the system MRI safe?
MRI scans and procedures must not be performed until the OrthoPak Stimulator System has actually been totally removed.
Is the system safe come use during pregnancy?
Use of the OrthoPak Stimulator System throughout pregnancy has actually not been evaluated; therefore it’s not recommended.
will certainly insurance sheathe the expense of the device?
Insurance coverage varies relying on your patient"s insurance money plan. The OrthoPak Stimulator device is normally recognized through Medicare, Medicaid, worker’s compensation and private and public wellness plans. Zimmer Biomet’s patient Advocacy group is accessible to help your patients and discuss any questions about insurance coverage, deductibles and potential out-of-pocket expenses. Patients may contact our patient Advocacy team at 1-888-236-3652.
Who have to the patient call if they have actually questions or need to order supplies?
Zimmer Biomet Customer care Representatives are prepared to price questions and can be reached at 1-800-526-2579, expansion 6000.
Representatives are accessible from 8:30 am to 5:00 pm (EST), Monday through Friday. At other times, please leaving a clear post for a return contact by the next company day.
The OrthoPak Stimulator device is basic to use, portable and also battery operated.
The maker is a small, light load non-invasive bone growth stimulator which permits patients come treat when going about their day-to-day routine.
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Compliance monitoring continuously tracks therapy progress.
Over 100,000 patients have actually been treated with the OrthoPak Stimulator System. 3
The OrthoPak Stimulator mechanism is FDA approved and also has an ext than 30 years of clinical use in boosting patients’ lives.1