Affirm Analytical Report

winter 2006 volume 5 issue 6

laser & light technology

Analytical Report Affirm

SKIN REJUVENATION SYSTEM By David Cauger, Contributing Editor

This is the last of my on-site product reviews for 2006. I have covered many difficult subjects in a way I hope connects to the aesthetic professional. Technology and the use of it improve with time. Mindful of this, I owe the readership of ATnT some clarifications and retractions. Of particular note, there are many product improvements. So my next report will be a retrospective look at several products and how they have improved. My only defense is that I usually cover the latest products where it is difficult, if not impossible, to receive impartial feedback from my network of cosmetic surgeons and dermatologists. With that being said, most of the Analytical reports are still a solid and unbiased source. I would like to thank the many people who have written me and with appreciative comments. I would like also to thank the Editor in Chief, Ms. Cindy Vandruff for allowing me an almost free rein to report

C

Cynosure, Westford, MA (NASDAQ):

debates over the concepts of fractional

CYNO has developed perhaps the

thermolyisis with some of the finest

most comprehensive skin rejuvenation

scientific and clinical people in the

system in the medical aesthetic market.

industry. This is a subject I have

The demand for non-surgical skin

objectives were to understand the

fast with only Botox™ and hair

optics, the power of each “microbeam,”

removal being more

popular. I will provide “skin rejuvenation”

and my reasoning for

year I hope to weed out the “bad apples.” At

why I think the Affirm™

least one analytical report will “name names”

is more sensible and

are best to avoid. I currently have no financial interest, nor do I receive compensation from Aesthetic Trends and Technologies

The demand for non-surgical skin rejuvenation procedures is growing fast with only Botox™ and hair removal being more popular.

a clear definition of

where the science leads me. 2007 will be the

and provide the readers with what products

been monitoring for two years. My

rejuvenation procedures is growing

comprehensive approach later in the

clinical rationale for use, and many

article.

other questions relating to clinical

I visited Cynosure’s headquarters in June 2006 for discussions and

outcomes verses traditional nonablative devices.

outside reimbursement for travel expenses. I currently own no stock in any laser company nor receive compensation for speaking

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engagements for the promotion of one light based product over another.

winter 2006 | www.aesthetictrends.com

Additionally, all of the above are

BRIEF BACKGROUND Around 2004 Drs. Rox Anderson

concept has become known as “distributed spot treatment” [DST]. The idea was based on an obvious observation: Small wounds heal faster

Absorption Coefficient (cm4)

introduced a new concept. This

non-prescription topical agents.

1,000

and Dieter Manstein working at Harvard’s Photomedicine Laboratories

augmented by both prescription and

10,000

than big wounds, and are less likely to

100

THE “FRACTIONAL” FACTS

10

Lasers have a variable “attraction”

1

or absorption to water as the chart

0.1 560-950 XPL 1440 1550

0.01

0.001

scar.

0.0001

Water

0.4

0.6 0.8 1

2

4

6 8 10

Wavelength (um) l

THE FRACTIONAL CONCEPT My humble opinion is that Drs.

Figure 1: Absorption characteristics by wavelength.

Anderson and Manstein looked at this

devices in both the ablative CO2 and non-ablative treatments. Both have many clinical indications and responses. First, let’s look at the much maligned CO2 laser.

The carbon dioxide laser (CO2) at

glance it may seem like a very small difference but is in fact a very, very large difference. It is interesting that the other 1550nm or 1540nm with a very high “attraction” to water. An “apple to

of the papillary dermis which

apples” comparison with the Affirm’s

(depending on the anatomical

1440nm dictates from Beer’s law

location) may be as deep as 100 to

that over 2-1⁄2 times less energy

250 microns or 1⁄4 of a millimeter

needs to be used to create the same

deep.

“microwound” as with a 1550nm or

leads to more dramatic and consistent improvement in both

10,900nm is still the gold standard

wrinkles and tissue laxity than

for patients of lighter skin types,

current non-ablative methods.

advanced photodamage, deeper

However, ablating the reticular

What has emerged is a new and better way to stimulate the immune system response versus bulk heating non-ablative devices.

1540nm. More energy equals more depth equals more pain. So what exactly is going on here with these fractional technologies? When Fraxel (Reliant Technologies, (Mountain View, CA) first hit

dermis leads to numerous

the market, the claims were that

complications such as

fractional thermolyisis could only be

tissue necrosis, scarring

accomplished using a 1550nm fiber

and prolonged wound

laser, due to characteristics the device

healing, lasting many

had (low divergence spot). According

months.

to Reliant, by using this rather

In this age where

expensive fiber laser, you need the

rhytides, elastosis, etc. In the hands

a great majority of patients cannot

optical tracking technology and blue

of a skilled and experienced cosmetic

tolerate the “downtime” of the CO2

paste to make it work. Unfortunately

physician, the results can be truly

trends have shifted to the use of

for Reliant, it is not the only way or

remarkable and life altering for

non-ablative treatments to produce

even the better way to achieve the

patients. However, its proper use

new collagen, treat dynamic wrinkles

realistic results of this technology.

requires a high degree of skill and

with Botox® and address small

The idea of fractional thermolyisis

training.

vascular and pigmented lesions with

was to move closer to CO2 by avoiding

the intense pulsed light or lasers.

treatment limitations and side effects.

The art of CO2 procedures is to

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of fractional thermolyisis. At first

typically remove a great majority

This limited depth of treatment

THE GOLD STANDARD

important in one’s understanding

fractional devices use the Er:YAG at

concept as a paradigm shift from the bulk heating concepts of traditional

indicates (Fig. 1). This is very

winter 2006 | www.aesthetictrends.com

What has emerged is a new and better

Target Depth per Technology

way to stimulate the immune system response versus bulk heating non-

CAP Depth~100-300 lum

ablative devices. IPL Depth~500 lum

Fractional Depth~250-10000 um l

THEORETICAL JARGON One can theorize all they like; but if

Deep Heating/ Skin Tightening Depth~1000-3000 lum

collagen synthesis is not achieved near the epidermis in the upper papillary dermis, will the wrinkle smooth out? I doubt it. Deeper down, nobody really Not to Scale

understands the effect on superficial tissue of a treatment that penetrates several times deeper in the dermis than CO2.

for skin laxity applications in 2007.

heating in between these microbeams.

This is the reason for my rather bold

This combination of background heat

mechanisms are neatly divided

statement in the first paragraph of this

with high energy heat means that

into three phases: inflammation,

article.

fewer passes are required for treatment,

The known wound healing

proliferation, and remodeling. I think all of these phases are still relevant

This means the physician may then treat small “reds and browns,” small

There is a high degree of synergy potential with Affirm for any surgeon operating on the face.

This low level heat stimulates

non-dynamic rhytides,

fibroblasts in the upper papillary

and finally skin laxity

dermis where a clinical result

in select patients. This

will be noticed. I have not seen

upgrade path will be

documentation to support the

a very comprehensive

efficacies of this “background energy,”

tool to augment

but it certainly can only help.

Botox® and dermal

Therefore, 15% of the 10mm

with the creation of very small micro-

fillers as combination therapies with

spot is treated with approximately

wounds. However, it is my humble

the Affirm, and indeed, even enhance

1,000 microbeams of high energy

opinion they are not equal in relevance

the outcome of many cosmetic facial

and 85% of the tissue being treated

when using fractional technology

surgical procedures. In short, there

with “background” lower energy.

versus bulk heating technologies,

is a high degree of synergy potential

Fraxel is 20% of high energy and

whether ablative or non-ablative.

with Affirm for any surgeon operating

0% low energy. The Pixel device

on the face.

(Alma, Ft Lauderdale, FL) is not a serious fractional device as it lacks

AFFRIM: THE MOST COMPREHENSIVE At approximately 55ºC collagen “shrinkage” occurs. This is not the

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leading to faster treatment time.

AFFIRM “CAP” TECHNOLOGY Combined Apex Pulse technology

nature of any fractional device. The

means that approximately 1,000

micro thermal columns of injury

high energy microbeams create

with any of these devices are fully

1,000 coagulated zones of 100-300

coagulated. However, I am told the

microns deep within each 10mm spot.

Affirm will be field upgradeable

Additionally, there is a lower level

winter 2006 | www.aesthetictrends.com

the power to go beyond depths of 60 microns -- something one can do with a microdermabrasion unit. The new Palomar fractional device uses 1540nm and, unlike the IR handpiece, can deliver some energy. So if you now own a StarLux, this may be a logical option if you are on a tight budget. At

of the 1550nm and 1540nm over time and devising an ingenious diffractive optical element. Quite frankly I have never seen anything so elegant and clever in this small industry as Cynosure’s “super micro lens.” More Unnecessary treated tissue

importantly, the Affirm understands the limits of the technology and so decided wisely to add an optional IPL that has enhanced epidermal cooling.

1440 nm Depth of penetration ~ 300 microns

1540 nm Depth of penetration ~ 800 microns

This, they call the Xenon Pulsed Light (XPL). In short, Affirm uses fractional technology but understands its limits as well as the dubious rationale of

last glance the StarLux was still a 400 watt device. A great IPL, but similar

creating wounds in the deeper dermis

technique. I had moderate erythema and went

to having a Ferrari with a Hyundai

on a facility tour with Dr. Ray Sierra,

engine. Noteworthy aesthetic lasers

Chief Technology Officer, for about 45

have 15,000 to 25,000 watts.

MY EXPERIENCE During my visit Cynosure was in the midst of clinical training, which allowed

3J/cm2. The upper end is 8 J/cm2.

visible or even wanted. Due to the characteristics of the

minutes. The following day I had slight

pulsed YAG laser, relatively high rep

erythema in the treated area, and by

rates (up to 2-Hz), large spot sizes

evening it was gone. I will report later

(10-mm), and an array delivery system

to the readers of ATnT as to the results

which can deliver a high density

following my 3rd treatment.

of treatment spots (so treatment is delivered in 1-2 passes rather than

me to experience a treatment. They decided to set the device at

where a clinical result may not be

5-10 passes as with Fraxel), treatment

WHY IS AFFIRM BETTER? The reality is I think the

I was feeling brave so I instructed to

developers of the Affirm had the

treat at 4.5 J/cm2. The treated area

advantage of looking at the downsides

was on the lower peri-ocular region

is much faster than with the Fraxel system. In the clinical trial reported by Robert Weiss at this year’s ASLMS

on both sides of the face. They used their 10mm spot, and in less than two minutes I was finished. No topical anesthesia was used. We did not even have a cool pack on hand as the procedure was surprisingly far more comfortable than competing treatments I have experienced. The user interface is simple. Only fluence and speed are adjustable for the CAPSM treatment, and the system includes a tutorial mode to allow operators to practice proper treatment

4—

Before (Left) and 6 Months After (Right) 3 Treatments Photos Courtesy of Dr. R. Weiss

winter 2006 | www.aesthetictrends.com

meeting, subjects were treated with

micro wound size, below the upper

only cold air for anesthesia, describing

intermediate zone of the dermis need

the discomfort as similar to laser

to be explained more thoroughly to

because there are so many variables.

hair removal. By comparison, topical

physicians with strong supporting

First, if you are a cosmetic surgeon who

anesthesia is the order of the day

evidence.

operates on the face and have no aesthetic

with the Fraxel device, often with air cooling for backup. When asked about this difference in discomfort, I was

WHAT IS BEST FOR MY PRACTICE? Here is where I get into trouble

light based devices, I would recommend

WHAT PATIENTS WANT

the Affirm. I would also recommend you

Patients seeking “skin

invest in a hair removal laser as well.

told the the combination of laser pulse

rejuvenation” or anti-aging treatment

If you have an IPL already, select

width and depth of treatment likely

desire resolution of rhytides, capillary

the Affirm without the XPL. If you find

account for the difference.

damage and pigmented lesions, not

patients are waiting for IPL treatments,

the promise of a mysterious new

then it is worth it to buy Affirm with XPL.

Faster treatments, less painful,

Patients seeking “skin rejuvenation” or anti-aging treatment desire resolution of rhytides, capillary damage and pigmented lesions, not the promise of a mysterious new rejuvenation they cannot see and nobody can prove.

rejuvenation

It is a superior IPL, and the additional cost

they cannot

is less than most low end IPL’s. So in this

see and

sense it is a bargain.

nobody can

If you are a cosmetic surgeon, then

prove. They

the Affirm is even more compelling. This

also want the

is because the device will soon have a

convenience

field upgradeable component for skin

of speed and

laxity. Sophisticated cosmetic surgeons

easier to operate, less time in office,

certainly they do not want a lot of

have learned to use the ThermaCool

outcomes that are just as good,

pain. Here, the Affirm 1140-nm with

(Thermage, Haywood, CA) and the Titan

or better. These are the hallmark

XPL wins the battle on all points.

(Cutera, Brisbane CA) to improve results

characteristics of a true practice building aesthetic tool.

HISTOLOGIC REALITY If one examines the histology of photoaged, elastotic tissue, the depth of elastosis is typically limited to 100 to 300 microns in depth. The Affirm’s depth of penetration of 100-300 microns specifically targets the photo-aged tissue. In fact, if elastosis extends beyond 500 micron range it is classified as a disease. This again begs the argument: why is deeper better? Since we have a very limited understanding of the fibroblast and skin cells, why go so deep? What is the purpose? The benefits of high temperatures applied by coherent light, even of the

5—

Before (Left) and One Month After (Right) 3 Wrinkle Reduction Treatments. Photos Courtesy of Dr. Bruce Katz.

winter 2006 | www.aesthetictrends.com

CONCLUDING REMARKS

Affirm 1440 Handpiece

In the world of technology being first is quite often “not best.” This is because competitors can learn from your mistakes and perhaps devise a new and better approach, one that costs less and has many advantages. Patient competition is growing. At the same time patients are becoming more sophisticated. If you are still relying on your CO2 to augment your procedures, I suggest you keep your CO2 but invest in a technology that of their procedures. Cynosure is well

offers a wide range of treatments that

aware of the depth and temperature

create new possibilities of improved

required; and although I cannot say for

results as well as positive patient

sure, I am confident the upgrade will

referrals.

be at least equal to the two skin laxity

Please forward questions by email.

devices on the market. The upgrade

Please include the name of your

will definitely be much less than buying

practice and a telephone number.

a single purpose ThermaCool, and most

M.D. or licensed practioner authorized

likely will be less or equal to adding

by an M.D. Please be specific in your

Titan to your Cutera device, though I am

questions and leave a convenient time

speculating at this time.

to call you if it is necessary.

Aesthetic Trends’

REFERENCES: 1. Fitzpatrick, R.E., Tope, W.D., Goldman, M.P., et al. Pulsed carbon dioxide laser: a comparative clinical and histological study of cutaneous resurfacing in a porcine model. Arch Dermatol. 1996: 132:469-471 2. Falabella, A.F., Falanga, V., The Biology of Skin, pp 281-294, 2001 Parthenon Publishing Group Inc. 2001 3. Trautinger, F. Heat Shock Proteins in the photobiology of human skin. Journal of Photochemistry and Photobiology B: 63 (2001) 70-77.

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winter 2006 | www.aesthetictrends.com

Contributing Editor David M. Cauger is President of Boston Aesthetics, LLC, a company that specializes in the development and implementation of strategies for increased cosmetic practice success. In providing this information, Mr. Cauger is open to telephone consultations for M.D.s only between the hours of 2:00 p.m. and 5:00 p.m. Eastern Time. He can be reached at the following number: 508.460.1128 or email him at [email protected].