affirm analytical report

8/14/2019 Affirm Analytical Report

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C

winter 2006

volume 5

issue 6

laser & light technology

Analytical ReportAffirmSKIN REJUVENATION SYSTEM

By David Cauger, Contributing Editor

Cynosure, Westford, MA (NASDAQ):

CYNO has developed perhaps themost comprehensive skin rejuvenation

system in the medical aesthetic market.

The demand for non-surgical skin

rejuvenation procedures is growing

fast with only Botox and hair

removal being more

popular. I will provide

a clear definition of

skin rejuvenation

and my reasoning for

why I think the Affirmis more sensible and

comprehensive approach later in the

article.

I visited Cynosures headquarters

in June 2006 for discussions and

debates over the concepts of fractional

thermolyisis with some of the finestscientific and clinical people in the

industry. This is a subject I have

been monitoring for two years. My

objectives were to understand the

optics, the power of each microbeam,

clinical rationale for use, and many

other questions relating to clinical

outcomes verses traditional non-

ablative devices.

The demand for non-surgical skin rejuvenatiprocedures is growing fast with only Botoxand hair removal being more popular.

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

where the science leads me. 2007will be the

year I hope to weed out the bad apples. Atleast one analytical report will name names

and provide the readers with what products

are best to avoid.

I currently have no financial

interest, nor do I receive compensation

from Aesthetic Trends and Technologies

outside reimbursement for travel expenses. I

currently own no stock in any laser company

nor receive compensation for speaking

engagements for the promotion of one light

based product over another. winter 2006 | www.aesthetictrends.com


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winter 2006 | www.aesthetictrends.com

BRIEF BACKGROUND

Around 2004 Drs. Rox Anderson

and Dieter Manstein working at

Harvards Photomedicine Laboratories

introduced a new concept. This

concept has become known asdistributed spot treatment [DST].

The idea was based on an obvious

observation: Small wounds heal faster

than big wounds, and are less likely to

scar.

THE FRACTIONAL CONCEPT

My humble opinion is that Drs.

Anderson and Manstein looked at this

concept as a paradigm shift from the

bulk heating concepts of traditionaldevices in both the ablative CO

2

and non-ablative treatments. Both

have many clinical indications and

responses. First, lets look at the much

maligned CO2

laser.

THE GOLD STANDARD

The carbon dioxide laser (CO2) at

10,900nm is still the gold standard

for patients of lighter skin types,

advanced photodamage, deeper

rhytides, elastosis, etc. In the hands

of a skilled and experienced cosmetic

physician, the results can be truly

remarkable and life altering for

patients. However, its proper use

requires a high degree of skill and

training.

The art of CO2

procedures is to

typically remove a great majority

of the papillary dermis which

(depending on the anatomical

location) may be as deep as 100 to

250 microns or 14 of a millimeter

deep.

This limited depth of treatment

leads to more dramatic and

consistent improvement in both

wrinkles and tissue laxity than

current non-ablative methods.

However, ablating the reticular

dermis leads to numerous

complications such as

tissue necrosis, scarring

and prolonged wound

healing, lasting many

months.

In this age where

a great majority of patients cannot

tolerate the downtime of the CO2

trends have shifted to the use of

non-ablative treatments to produce

new collagen, treat dynamic wrinkles

with Botox and address small

vascular and pigmented lesions with

the intense pulsed light or lasers.

Additionally, all of the above are

augmented by both prescription and

non-prescription topical agents.

THE FRACTIONAL FACTS

Lasers have a variable attraction

or absorption to water as the chart

indicates (Fig. 1). This is very

important in ones understanding

of fractional thermolyisis. At first

glance it may seem like a very small

difference but is in fact a very, very

large difference.

It is interesting that the other

fractional devices use the Er:YAG at

1550nm or 1540nm with a very high

attraction to water. An apple to

apples comparison with the Affirms

1440nm dictates from Beers law

that over 2-12 times less energy

needs to be used to create the same

microwound as with a 1550nm or

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

the market, the claims were that

fractional thermolyisis could only be

accomplished using a 1550nm fiber

laser, due to characteristics the device

had (low divergence spot). According

to Reliant, by using this rather

expensive fiber laser, you need the

optical tracking technology and blue

paste to make it work. Unfortunately

for Reliant, it is not the only way or

even the better way to achieve the

realistic results of this technology.

The idea of fractional thermolyisis

was to move closer to CO2

by avoiding

treatment limitations and side effects.

Figure 1: Absorption characteristics by wavelength.

AbsorptionCoefficient(cm4)

10,000

1,000

100

10

1

0.1

0.01

0.001

0.0001

Wavelength (um)l

0.4 0.6 0.8 1 2 4 6 8 10

560-950 XPL14401550

Water

What has emerged is a new and better way tostimulate the immune system response versusbulk heating non-ablative devices.


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What has emerged is a new and better

way to stimulate the immune system

response versus bulk heating non-

ablative devices.

THEORETICAL JARGONOne can theorize all they like; but if

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

understands the effect on superficial

tissue of a treatment that penetrates

several times deeper in the dermis

than CO2.

The known wound healing

mechanisms are neatly divided

into three phases: inflammation,

proliferation, and remodeling. I think

all of these phases are still relevant

with the creation of very small micro-

wounds. However, it is my humble

opinion they are not equal in relevance

when using fractional technology

versus bulk heating technologies,

whether ablative or non-ablative.

AFFRIM: THE MOST COMPREHENSIVE

At approximately 55C collagen

shrinkage occurs. This is not the

nature of any fractional device. The

micro thermal columns of injury

with any of these devices are fully

coagulated. However, I am told the

Affirm will be field upgradeable

for skin laxity applications in 2007.

This is the reason for my rather bold

statement in the first paragraph of this

article.

This means the physician may then

treat small reds and browns, small

non-dynamic rhytides,

and finally skin laxity

in select patients. This

upgrade path will be

a very comprehensive

tool to augment

Botox and dermal

fillers as combination therapies with

the Affirm, and indeed, even enhance

the outcome of many cosmetic facial

surgical procedures. In short, there

is a high degree of synergy potential

with Affirm for any surgeon operating

on the face.

AFFIRM CAP TECHNOLOGY

Combined Apex Pulse technology

means that approximately 1,000

high energy microbeams create

1,000 coagulated zones of 100-300

microns deep within each 10mm spot.

Additionally, there is a lower level

heating in between these microbeams.

This combination of background heat

with high energy heat means that

fewer passes are required for treatment,

leading to faster treatment time.

This low level heat stimulates

fibroblasts in the upper papillary

dermis where a clinical result

will be noticed. I have not seen

documentation to support the

efficacies of this background energy,

but it certainly can only help.

Therefore, 15% of the 10mm

spot is treated with approximately

1,000 microbeams of high energy

and 85% of the tissue being treated

with background lower energy.

Fraxel is 20% of high energy and

0% low energy. The Pixel device

(Alma, Ft Lauderdale, FL) is not a

serious fractional device as it lacks

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

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

Target Depth per Technology

Not to Scale

IPLDepth~500 uml

CAPDepth~100-300 uml

Fractional

Depth~250-10000 uml

Deep Heating/Skin TighteningDepth~1000-3000 uml



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last glance the StarLux was still a 400

watt device. A great IPL, but similarto having a Ferrari with a Hyundai

engine. Noteworthy aesthetic lasers

have 15,000 to 25,000 watts.

MY EXPERIENCE

During my visit Cynosure was in the

midst of clinical training, which allowed

me to experience a treatment. They

decided to set the device at

3J/cm2

. The upper end is 8 J/cm2

.

I was feeling brave so I instructed to

treat at 4.5 J/cm2. The treated area

was on the lower peri-ocular region

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

technique.

I had moderate erythema and wenton a facility tour with Dr. Ray Sierra,

Chief Technology Officer, for about 45

minutes. The following day I had slight

erythema in the treated area, and by

evening it was gone. I will report later

to the readers of ATnT as to the results

following my 3rd treatment.

WHY IS AFFIRM BETTER?

The reality is I think thedevelopers of the Affirm had the

advantage of looking at the downsides

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

Cynosures super micro lens. More

importantly, the Affirm understands

the limits of the technology and so

decided wisely to add an optional IPL

that has enhanced epidermal cooling.

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

creating wounds in the deeper dermis

where a clinical result may not bevisible or even wanted.

Due to the characteristics of the

pulsed YAG laser, relatively high rep

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

(10-mm), and an array delivery system

which can deliver a high density

of treatment spots (so treatment is

delivered in 1-2 passes rather than

5-10 passes as with Fraxel), treatment

is much faster than with the Fraxel

system.In the clinical trial reported by

Robert Weiss at this years ASLMS

1440 nmDepth of penetration ~ 300 microns

1540 nmDepth of penetration ~ 800 microns

Unnecessarytreatedtissue

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


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meeting, subjects were treated with

only cold air for anesthesia, describing

the discomfort as similar to laser

hair removal. By comparison, topical

anesthesia is the order of the day

with the Fraxel device, often with air

cooling for backup. When asked about

this difference in discomfort, I was

told the the combination of laser pulse

width and depth of treatment likely

account for the difference.

Faster treatments, less painful,

easier to operate, less time in office,

outcomes that are just as good,

or better. These are the hallmark

characteristics of a true practice

building aesthetic tool.

HISTOLOGIC REALITY

If one examines the histology ofphotoaged, elastotic tissue, the depth

of elastosis is typically limited to 100 to

300 microns in depth.

The Affirms 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 wehave 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

micro wound size, below the upper

intermediate zone of the dermis need

to be explained more thoroughly to

physicians with strong supporting

evidence.

WHAT PATIENTS WANT

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. Theyalso want the

convenience

of speed and

certainly they do not want a lot of

pain. Here, the Affirm 1140-nm with

XPL wins the battle on all points.

WHAT IS BEST FOR MY PRACTICE?

Here is where I get into trouble

because there are so many variables.

First, if you are a cosmetic surgeon who

operates on the face and have no aesthetic

light based devices, I would recommendthe Affirm. I would also recommend you

invest in a hair removal laser as well.

If you have an IPL already, select

the Affirm without the XPL. If you find

patients are waiting for IPL treatments,

then it is worth it to buy Affirm with XPL.

It is a superior IPL, and the additional cost

is less than most low end IPLs. So in this

sense it is a bargain.

If you are a cosmetic surgeon, then

the Affirm is even more compelling. Thisis because the device will soon have a

field upgradeable component for skin

laxity. Sophisticated cosmetic surgeons

have learned to use the ThermaCool

(Thermage, Haywood, CA) and the Titan

(Cutera, Brisbane CA) to improve results

Patients seeking skin rejuvenation or anti-agingtreatment desire resolution of rhytides, capillary damage

and pigmented lesions, not the promise of a mysteriousnew rejuvenation they cannot see and nobody can prove.

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


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CONCLUDING REMARKS

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 thatcosts 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

offers a wide range of treatments that

create new possibilities of improved

results as well as positive patient

referrals.Please forward questions by email.

Please include the name of your

practice and a telephone number.

M.D. or licensed practioner authorized

by an M.D. Please be specific in your

questions and leave a convenient time

to call you if it is necessary.

Aesthetic Trends

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].

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.

Affirm 1440 Handpiece

of their procedures. Cynosure is well

aware of the depth and temperature

required; and although I cannot say for

sure, I am confident the upgrade willbe at least equal to the two skin laxity

devices on the market. The upgrade

will definitely be much less than buying

a single purpose ThermaCool, and most

likely will be less or equal to adding

Titan to your Cutera device, though I am

speculating at this time.

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