General Issues
What is the Transderm Ionto System?
The Transderm Ionto System is a powered drug delivery system that is indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections. In other words, it must be used by a doctor and only with approved substances.
How does the Transderm Ionto System work?
Mattioli Engineering's Transderm Ionto System allows for the transdermal delivery of ionic drug solutions into the body. Transdermal delivery enables active principles to enter the dermis without the need for injections or syringes. The Ultrapeel Transderm Ionto System combines traditional microdermabrasion with Dermoelectroporation, and is designed to provide the benefits of transdermal drug delivery treatments without the limiting side effects of other tradtional techniques.
The Transderm Ionto System uses microdermabrasion to exfoliate the stratum corneum to ensure reproducibility - along with Dermoelectroporation, which allows the principle to enter the dermis by means of low energy, electrical pulses to deliver the ionic drug solution into the body.
Dermoelectroporation, when combined with microdermabrasion, boosts the transdermal delivery rate to get a higher flow than normally obtained from a topical application (five times the topical application).
What is the Transderm Ionto System indicated for?
As the FDA clearance states, the Transderm Ionto System is a powered drug delivery system that is indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
What is Dermoelectroporation?
Dermoelectroporation is a new, patented, proprietary technology from Mattioli Engineering Research Labs. It is a non-invasive method of delivery drugs into the body. Dermoelectroporation creates "channels" in the skin to allow ionic drug solutions to penetrate due to controlled electroporation-like continuous reversed polarity electrical pulses, increasing the skins permeability and allowing for the transdermal delivery of drugs as would occur in traditional iontophoresis. This pulsed iontophoresis with safe, current-limited, pulsed "electroporation-like" waveforms, allows for the delivery of both micro- and macro-molecules without modifying the ionic drug solutions pH and avoiding any type of electrolysis reaction at the electrodes.
Dermoelectroporation technology has no effect on the ionic drug solution being delivered.
How will the Transderm Ionto System benefit my practice?
The Transderm Ionto System is enhancing practices all over the world. Due to the Dermoelectroporation technology, practices are increasing their profits while maintaining and retaining those patients afraid of injections.
What are the advantages of using the Transderm Ionto System Vs other systems?
Transderm Ionto System is the ONLY system FDA cleared for Medical applications and is cleared as an alternative to injections.
It has the capability to transdermally deliver both micro- and macro molecules.
There is no electrolysis of the ionic drug solution, which ensures that the substance is delivered as a whole.
There is no variation in the ionic drug solution pH, ensuring that there is no irritation for the patient.
This system promotes the transdermal delivery rate by means of microdermabrasion and Dermoelectroporation.
There is a reproducibility of the dose delivered due to the preliminary microdermabrasion.
The vibration feature on board minimized the perception of electrical pulses for the patient.
The Transderm Ionto System is non-invasive.
How deep will the ionic drug solutions deliver?
The Transderm Ionto System is recognized to be able to transdermally deliver ionic drug solutions to the muscle membranes.
Does the Ultrapeel Transderm Ionto System need any type of carrier product to be effective?
No, the Transderm Ionto System does not need any carriers to be effective. Due to the Dermoelectroporation technology, all you need is your ionic drug solution - that's it!
Does the Ultrapeel Transderm Ionto System need a charged ionic drug solution to be effective?
No, the Transderm Ionto System does not nee a charged ionic drug solution to work properly.
The Transderm Ionto is not:
An Ultrasound device
An aesthetic-purpose unit
A cosmetic device
A multi-device unit
A massager
A microcurrent device
What substances or active principles can be used with the Transderm Ionto System?
Iontophoresis devices are cleared for all approved Iontophoresis drugs. Therefore, you may choose the ionic drug solution that is best suited for the specific application based on the existing medical literature.
What kind of applications can the Transderm Ionto System be used for?
Doctors in the United States are using the Transderm Ionto System successfully in dealing with various applications, such as skin texture enhancement treatments, pre-laser treatments, cellulite treatments, localized fat deposits, any type of mesotherapy application, etc.
How much is the Transderm Ionto System?
Please contact Mattioli Engineerings US Sales and Marketing Manager.
Regulatory Issues
What is the difference between the various transdermal delivery devices available on the US market?
In the US, as a rule, regardless of individual technical characteristics and performances, when they talk about transdermal delivery, they mean medical devices.
Medical devices must have FDA clearance (or 510K number) to be able to be sold on the market.
I'm considering a new transdermal delivery machine. How do I know that it's a medical device?
The company you are purchasing your transdermal delivery machine must be able to provide you with a FDA clearance or 510K number. In the US, the FDA clearance or 510K number is required for transdermal delivery devices.
If the new product does not have a FDA clearance, what kind of machine am I dealing with?
All manufacturers of Transdermal delivery devices must have FDA clearance. If a manufacturer does not have that, the machine in question might be a micro-current device indicated for cosmetic and not medical applications.
What if I want to use it anyway in-spite of the missing FDA approval?
In the US, if a doctor wants to use a machine that has not been FDA approved, he/she assumes responsibility fur using a non medical, FDA cleared machine in a medical environment.
What does it mean to have a FDA cleared machine vs a non FDA cleared machine?
FDA clearance is extremely important, especially in terms of liability, guarantee of efficacy, and assurance of safety for both patients and doctors.
Medical Practice Issues
My patients do not want needles. Is Dermoelectroporation technology any help with this?
As the FDA clearance statement states, "The Transderm Ionto System is a powered drug delivery system that is indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections."
For what kind of applications can I use with the Transderm Ionto System?
US doctors using the Transderm Ionto System are successfully dealing with various applications such as collagen and hyaluronic acid transdermal delivery treatments, pre-laser treatments for both hair removal and resurfacing. Some others are using Ultrapeel Transderm Ionto System with cancer drugs or steriod delivery. Some others are using Ultrapeel Transderm Ionto System for mesotherapy applications, skin bio revitalization, pain management, cellulite reduction, etc.
I'm a physician. Why should I consider Transderm Ionto System?
Transderm Ionto System not only provides a non-invasive alternative to injections that may help in minimizing skin trauma and pain associated with needles, while also allowing clients afraid of injections to have the benefit of minimizing concern over possible infectious disease hazards associated with needles, but it also delivers macro-molecules (15K Dalton +) in a short period of time. This is not possible with other Iontophoresis systems.
I'm a physical therapist. Why should I consider the Transderm Ionto System?
The Transderm Ionto System provides an alternative to injections and is a cost-effective solution to improve patients conditions with a therapy program. CAUTION - Ultrapeel Transderm Ionto System must be prescribed by a physician to be used for specific treatments.
My interest is in something that is limited to physicians rather than a product that every aesthician can purchase.
The Transderm Ionto System is for medical purposes only. As the FDA clearance states, "The Transderm Ionto Sytem is a powered drug delivery system that is indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections." It may only be used by doctors.
Does Mattioli Engineering supply ionic drug solutions?
No. Mattioli Engineering does not supply or package ionic drug solutions with our machines. We can recommend compounding pharmacies that sell appropriate solutions.
I'm a medical doctor. Can I use any ionic drug solution as I may wish?
You may use the ionic drug solution you wish, on your own indication.
What kind of Lidocaine do doctors use for pre-laser treatment?
Some doctors are using a brand of 2% Lidocaine HCL 1:100,000 Epinephrine.
I would like to know specifically how your product compares with the other products being used in other countries (for example, Canada).
There are two types of devices on the market -
1.) Micro-current devices (less than 1mA) - A micro-current device is used in cosmetic applications that do not require a FDA clearance. These devices are not for medical use and cannot be used, following FDA and US regulations, in medical applications.
2.) Medical device (more than 1mA) - All devices must be FDA cleared to be used for medical applications by a physician.
At the present time, the Ultrapeel Transderm Ionto System is the only FDA cleared machine for transdermal delivery using new pulsed technology instead of DC current. It is recognized as a medical device for transdermal delivery of ionic drug solutions into the body.
The Canadian devices, for example, must have a US FDA clearance, otherwise they are a micro-current cosmetic device. If Canadians market the device as a medical device without FDA clearance, they are conducting illegal marketing according to US regulations. FDA clearance is important, especially in avoiding liability, assure efficacy of performance, and safety for both the patient and the doctor.
How large of a molecule can you deliver with the Ultrapeel Transderm Ionto System? Growth factors? Collagen? Do you have a list of cocktails that are known to be transported effectively?
The Ultrapeel Transderm Ionto System can deliver macromolecules (more than 15K Dalton). Doctors in the US are transdermally delivering: Hyaluronic Acid, Collagen, Heparin, Elastine, Amino Acids, Vitamins, etc.
Does the Ultrapeel Transderm Ionto System require a charged ion? How about compounds that are not ionic? Do you use a carrier to deliver products or do you provide them without carrier solution?
The Transderm Ionto System does not need charged compounds or carriers to successfully transdermally deliver the intended solution. Non ionic drug solutions are not indicated to be used with the Transderm Ionto System. The system itself delivers the ionic drug solution (water based) from the probe to the patient in a timely manner through the Precision Liquid Dispenser (PLD).
Can I deliver gels or cosmetic creams with the Transderm Ionto System?
Non ionic drug solutions are not indicated to be used with the Transderm Ionto System. For instance, creams or gels, due to their own enhancers and carriers, can penetrate too deep and can irritate the patient.
Does the Ultrapeel microdermabrasion improve the transport? Do I need to perform a superficial or deep microdermabrasion treatment to receive the best results?
Ultrapeel microdermabrasion promotes transdermal delivery by exfoliating the skin to allow for better penetration of the ionic drug solution. It is always best to perform a microdermabrasion treatment that is more powerful than a superficial treatment.
Is the Ultrapeel Transderm Ionto System contraindicated for patients with a cardiac pacemaker or defibrillator?
According to FDA guidelines, the use of any electrotherapy device with a pacemaker or defibrillator is containdicated.
Can the Ultrapeel Transderm Ionto System be used safely with a patient who is pregnant?
The safety of any iontophoresis device with this patient population has not been established in literature - to date. So, in this particular condition, it is not encouraged.
Should I be concerned when using the Transderm Ionto System device around machinery or other implantable medical devices?
Some machinery or implantable medical devices may interfere with the operation of the Transderm Ionto System. Examples include equipment that generates high frequency or high electromagnetic radiation, patient monitoring equipment, and extermal defibrillators.
Will the Transderm Ionto System cause irritations or allergies on patients being treated?
From experience to date, the Transderm Ionto System does not cause allergies or irritation.
We recommend for doctors to not transdermally deliver ionic solutions over the eye to avoid possible problems with the retina.
Will my patients skin be read after a Transderm Ionto System treatment?
Small areas of redness may appear during the treatment, but these areas will disappear within a few minutes. Mattioli Engineering suggests that you not exert a lot of pressure while using the machine.
Can I use the Transderm Ionto System as a device for pain control?
Doctors are using the Transderm Ionto System for pain management applications.
Is there particular headprobe placement that is more effective on delivering solutions?
At this time, there is no particular placement for the headprobe. Mattioli Engineering recommends that you perform slow, circular movements without strong pressure, which allows for the users to receive the best treatment in minimal time.
How long does a treatment last? How frequently do I have to repeat the session?
It depends on the treatment - there is no general rule. Everything is physician dependent.
What should I do if the red LED lights up on the Transderm Ionto System head probe?
The red LED light indicates that the operator is not making sufficient contact with the patient's skin. Please reposition the probe to ensure good contact on the skin.
What do I do if I need to disconnect the probe from the patient during the middle of a treatment?
First, decrease the current to "0" to prevent an uncomfortable treatment for the patient. Then you can turn off the vibration feature and move the head probe away from the skin.
Do the delivery caps contain latex?
No. All Transderm Ionto System drug delivery caps, accessories and products are latex free.
Are the drug delivery caps reusable?
No, they are disposable and must be replaced between each treatment.
What should I do if the drug delivery cap is not sticking properly to the Transderm Ionto System probe?
If the drug delivery cap is not sticking well to the probe, it must be replaced with a new cap. Please make sure that the electrodes on the probe are clean and have been throroughly dried.
Can I use rubbing alchohol to clean the head probe?
New findings show that rubbing alcohol does not adversely affect the electrode life and can be used in cleaning the electrodes on the head probe.
What should be done if the treatment area is extremely hairy?
Excess body hair should be trimmed, not shaved, prior to the treatment. Shaving can cause irritation.
How do I determine the best dosage and number of treatments for a patient?
The dosage and number of treatments per patient depends on the desired outcome and response of each patient considering the ionic drug solution in use. The total number of treatments varies depending on the patient's response, the medication being administered, ad the severity of the condition.
What is the disposable cost per treatment for transdermal delivery?
The disposable cost per treatment is approximately $3 - $6 (maximum retail price on microdermabrasion) + $8.60 (maximum retail price on a single drug dispensing cap).
Technology Issues
What technology does the Transderm Ionto System use?
The Transderm Ionto System uses Dermoelectroporation technology. Dermoelectroporatoin uses pulsed iontophoresis (low currents from 1mA to 5mA) with electroporation-like pulsed waveforms (similar to those of electroporation, but completely different in time duration, value and electrical characteristics).
What is Dermoelectroporation?
Dermoelectroporation is a patented, proprietary technology from Mattioli Engineering that utilizes the skins waterbased "channels" to allow ionic drug solutions to penetrate due to controlled electroporation-like continuous reversed polarity electrical pulses.
