| Q. |
What is the 3M™ Microchannel Skin System? |
| A. |
It is a pretreatment system designed to create microchannels in the skin prior to performing dermatological applications and procedures. |
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| Q. |
Is the 3M™ Microchannel Skin System reusable? |
| A. |
No, this is a disposable system for single-patient use only. Microneedle patches are supplied in strips of 5 sterile patches. Each patch can be used on the same patient up to eight times in one treatment session. |
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| Q. |
Is it painful? |
| A. |
The microneedles on the 3M™ Microchannel Skin System typically penetrate only the epidermis, the outermost layer of skin, to a depth of less than 100 microns, so patients will feel minimal discomfort. |
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| Q. |
Can I use the 3M™ Microchannel Skin System for repeat applications on the same spot on the skin? Will this result in scarring? |
| A. |
We have not tested repeat applications or scarring in human clinical testing. |
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| Q. |
Can you provide me with a copy of the clinical study data you have? |
| A. |
The clinical study results have been submitted to a leading dermatology journal for publication. Until it is accepted for publication we are unable to share this report. However, you can find a brief description of the trial at www.clinicaltrials.gov. In addition, if you have a specific question or concern, our clinical manager will be happy to review the data we have in house and respond to you. |
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| Q. |
Who can use the 3M™ Microchannel Skin System? |
| A. |
The 3M™ Microchannel Skin System is for use by professional medical or cosmetic dermatologists. Physicians may also recommend use of the 3M™ Microchannel Skin System at home. |
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| Q. |
What conditions, treatments or applications are appropriate for the use of the 3M™ Microchannel Skin System? |
| A. |
3M™ Microchannel Skin System is listed with US FDA as a 501(k) exempt Class I device, we are not authorized to state a specific drug or therapeutic application. 3M™ Microchannel Skin System is a medical pretreatment device for use prior to dermatological applications or procedures. As with most medical tools in your office, such as biopsy punches, needles or surgical instruments, there are many potential uses, and you will be in the best position to determine most appropriate applications.
Microneedles in general have been studied in many applications. You can learn more about these applications on the Publications page of our website, where we have listed a number of peer-reviewed journal articles.
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| Q. |
How do I use the 3M™ Microchannel Skin System? |
| A. |
The package insert provides complete instructions. A demonstration video is also available on the home page. After cleaning the area to be treated, snap the handle on to one patch – press gently in to the skin in a vertical up-and-down motion. When finished, squeeze the pins on the back of the patch to remove the patch from the handle and dispose of it. |
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| Q. |
Is this product FDA approved? |
| A. |
The 3M™ Microchannel Skin System is listed with the FDA as a 510(k) exempt Class I device (the lowest risk medical device category). |
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| Q. |
Are there any specific disposal requirements for the microneedle patches? |
| A. |
Follow your current office procedures for similar products, such as a biopsy punch. |
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| Q. |
Where can I find more information on the use of microneedles? |
| A. |
Go to the Publications page of this website. The page provides information on published journal articles on microneedles and their use in dermatology. |
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| Q. |
How do I clean the handles? |
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The handles are intended for single-patient use. Please do not autoclave the handles. |
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| Q. |
What are the microneedle specifications? |
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Each patch consists of 351 microneedles/cm2. Microneedles are 650 microns in length and are made of Class VI medical grade polymer. With gentle pressure the microneedles penetrate less than 100 microns into the skin. |
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| Q. |
There is some discoloration on the microneedle patch. It looks dirty. Should I be concerned? |
| A. |
No. The variation of color you observe is a property of the plastic and the process used to make the array. This kind of variation is normally seen with molded plastic parts. The microneedle patch is manufactured in a clean environment and is sterillzed prior to shipping. The discoloration is not a cause for concern. |
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| Q. |
Is 3M™ Microchannel Skin System available outside of the U.S.? |
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At this time, 3M™ Microchannel Skin System is available only in the U.S. |
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| Q. |
How do I request samples? |
| A. |
Samples are available to clincians practicing in the U.S. Sample requests can be submitted through the Contact Us page of this website, or by contacting Henry Schein, the exclusive U.S. distributor of the 3M™ Microchannel Skin System. |
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| Q. |
What is the estimated price for dermatology offices? |
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3M™ Microchannel Skin System is availabe in the U.S. exclusively through Henry Schein. It is very economically priced. Please contact your Henry Schein representative or log onto the Henry Schein website for pricing information. |
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| Q. |
Is there a reimbursement code for this product? |
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Due to its low cost as a medical supply item, no reimbursement code is needed. |
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| Q. |
How can I purchase this product? |
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The system is available for purchase in the U.S. exclusively through Henry Schein, the exclusive U.S. distributor. The product is available in an Office Pack (25 patches, 5 handles), Patient Pack (5 patches, 1 handle) or Handle Pack (5 handles).
To order the 3M™ Microchannel Skin System or to have a sales representative call your office, please contact Henry Schein.
If you have any questions regarding the 3M™ Microchannel Skin System, please contact the 3M Health Care Help Line at 1-800-228-3957.
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