What is BIOSTIM® therapy?
BIOSTIM® therapy is a bone growth stimulation device which enhances fracture healing.
When BIOSTIM® therapy indicated?
If, after trauma a fracture does not show progression towards healing after more than 3 months, BIOSTIM® therapy can be adopted to trigger osteogenesis and to finalise the repair process.
How does BIOSTIM® therapy work?
BIOSTIM® therapy delivers a pulsed electromagnetic fields that induces at the fracture site an electric field that triggers bone healing.
The treatment efficacy depends on the physical parameters of the electromagnetic signal: 75 Hz, 1.3 ms pulse duration, 2 mT magnetic field.
In summary, BIOSTIM® therapy biophysical signal acts on the cell membrane favouring the release of calcium ions from the endoplasmic reticulum.
The localised increase in calcium triggers the bone repair process.
How to know if BIOSTIM® therapy is working properly?
The power button is pressed for approximately 2 seconds (until a confirmation "beep" is heard) the led display lights up with a steady green light and the word "IGEA" along the word "BIOSTIM" appears.
The generator then performs a test to detect the presence of the solenoid and automatically sets the correct parameters according to the applied solenoid.
After a few seconds the therapy commences:
- The green light will flash and the display will show the timing (hours and minutes) of the performed therapy. The counter is updated for each minute the therapy is being performed until the daily therapy time set at 8 hours is completed.
- Once the daily therapy time is reached, the system emits 3 beeps, stops dispensing therapy, and the green light becomes fixed.
Is BIOSTIM® therapy safe?
Its biological and electrical safety are widely documented.
Thousands of patients have successfully used BIOSTIM® therapy in the absence of negative side effects.
BIOSTIM® therapy is manufactured in compliance with the IEC 60601-1 standards, meets the requirements of directive 93/42/EEC and it is CE0051 marked.
What does BIOSTIM® therapy feel like and what effect does it have on daily activities?
The patient does not feel the presence of the electromagnetic field generated by BIOSTIM® therapy.
The treatment does not interfere with daily activities.
To guarantee the effectiveness of the therapy, the treatment parameters (in compliance with the CEI EN 60601-1-11 standard) are preset and can not be changed, even accidentally, by the patient.
Does the BIOSTIM® therapy coil (applied part) work through clothes?
Yes, in fact it is not advisable to put the applied part (coil) in direct contact with the skin.
We would advise placing the applied part (coil) on top of clothing or dressing.
How long does daily treatment last?
Daily treatment with BIOSTIM® therapy must be at least 6-8 hours (not necessarily consecutive) and can be done during night hours.
The attending physician will specify the total duration of the therapy in accordance to the pathology being treated.
Should BIOSTIM® therapy be used at the same time every day?
No, treatment can be carried out at any time of the day.
Daily treatment may be split into several shorter sessions, provided they are at least 2 hours per session.
What happens if I miss a treatment session?
It is advised to recommence the treatment program as soon as possible.
How long does healing take with BIOSTIM® therapy?
Treatment length depends on the severity of and length of time since fracture.
The doctor prescribes the duration of the therapy based on his experience and on the results of clinical trials.
Before discontinuing therapy, even if there are clear signs of improvement, it is always necessary to firstly consult your doctor.
The constant daily use of BIOSTIM® therapy and the continuity of treatment until recovery is essential to promote the healing process.
Can BIOSTIM® therapy be used by patients with a pace-maker?
Yes, however coils should be positioned at least 50 cm away from pace-maker.
In this situation, Cardiologist advice is recommended.
Can BIOSTIM® therapy be used during pregnancy?
The effects of BIOSTIM® therapy pulsed electromagnetic fields during pregnancy have not been investigated and, therefore, Physician advice is recommended.
Does BIOSTIM® therapy need special care or specific maintenance?
BIOSTIM® therapy is prepared and shipped to patients ready for use. No intervention or maintenance is required.
To guarantee the reliability of performance, BIOSTIM® therapy should be subjected to ordinary maintenance procedures and a control of the operating parameters (to be performed by the IGEA Service Centre) every 24 months of use (Guide IEC 62-122).
Does BIOSTIM® therapy have contraindications or side effects?
BIOSTIM® therapy has no contraindications or side effects.
The experience gained in treating over 300,000 patients guarantees the safety of all IGEA therapies.
I am a cancer patient, can I use BIOSTIM® therapy?
In patients with oncological diseases the use of BIOSTIM® therapy is not contraindicated.
However, we would advise you to consult your doctor.