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march . april 2006 volume 5 issue 2

laser & light technology

This is my first Analytical Report for 2006. This year I will be reporting on some of the latest technologies and their clinical applications and efficacies. Reporting on truly innovative devices is what defines these analytical reports. There have been several calls to Aesthetic Trends asking for supporting clinical data. Unfortunately, most new devices do not have substantial clinical data. It is my hope that more peer reviewed data is published on all light-based aesthetic devices, not just the latest products. The pulsed dye laser (PDL) is a notable exception in terms of the quality and quantity of peer reviewed studies. However, there is still little data concerning the effects of the 8 micro pulse structure of the PDL. What we do have are basic rules which predict how photons will affect tissue based on classification, color, mass, depth, location, etc. It is not simply my opinion that 6 or 8 sub pulses will reduce purpura. It is a logical conclusion based on the historical peer reviewed data of the PDL and the thermal relaxation time of vessels. The many emails I receive reflect a need to obtain unbiased information. Physicians are not physicists. I advise Physicians to understand what they intend to treat, what are their expectations, and what are the estimated percentages of skin types in area they practice. With these questions answered, I may assist you, the physician more accurately. Be advised that I have no financial interest in Candela Corporation. In providing this information, I am open to telephone consultations for M.D.s only between the hours of 2:00 p.m. and 5:00 p.m. Eastern Time. I can be reached at the following number: 508.460.1128. You may also email me at [email protected]

Analytical Report

Aesthetica, Platinum & Perfecta

CANDELA CORPORATION'S NEW GENERATION PULSE DYE LASERS

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By David Cauger, Contributing Editor

usability. pyogenic granulomas, and

Candela Corporation (NASDAQ: CLZR) has made significant technical improvements to their Vbeam pulsed dye laser. These improvements are incorporated into three new products: Aesthetica, Platinum, and Perfecta. I visited Candela Headquarters on January 5, 2006, to examine the products and determine how the technical changes to these pulsed dye lasers may expand and enhance clinical applications as well as improve The pulsed dye laser (PDL) has been in use for over 20 years. Its traditional uses include port wine stains, superficial hemangiomas, and a variety of acquired vascular lesions and facial and leg veins, including cherry angiomas, telangectasias, poikiloderma of Civatte. Although

PDLs have a very high attraction to the melanin, in the past technical limitations made treating pigmented lesions problematic. That is, until now. There are two major technical advances in Candela's new pulsed dye

The era of the pulsed dye "laser photofacial" has now arrived.

lasers which allow its expanded use in the treatment of pigmented lesions. The era of the pulsed dye "laser photofacial" has now arrived. The general terms "photofacial" or "photo-rejuvenation" are used to describe light-based treatments performed primarily for superficial vascular and abnormal pigmentation in the upper layers of skin on the face. The terms are also used to describe the stimulation of collagen in the

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upper papillary dermis which may reduce fine wrinkles. Understand that patients have a wide variety of acquired or congenital vascular and pigmented abnormalities which are beyond the scope of this article. Specific treatment guidelines and parameters for many of these conditions are included both on-screen and in a written manual of these products.

HOW DO THESE TWO NEW TECHNOLOGIES WORK?

The two major technical advances work together to significantly reduce purpura and allow the isolation of the target chromophore melanin. The first technology is the pigmented lesion handpiece. Please note the absorption coefficient chart (above right). As you can see, the 595nm wavelength has a high "attraction" to both melanin and oxyhemoglobin. To solve this problem of competing chromophores, Candela developed a pigmented lesion handpiece that pushes blood away from target area, leaving only the melanin target as the laser fires. This handpiece pushes the blood away from target area, leaving only the melanin target as the laser fires. Typical settings for benign pigmented lesions would be a 7 or 10mm handpiece at 5-8 J/cm2 using the pigmented lesion handpiece with a 1.5 millisecond pulse duration. Higher fluences may be necessary based on patient response. The clinical endpoint is a darkening or color change of the lesion. The treatment may be as fast as or faster than some IPL's as the laser will fire at 1.5 times per second. IPL's have large spot sizes but are much slower at optimum settings.

Absorption Coefficient Comparisons are bound to be made to IPL's, but one must remember the vast clinical applications of the long pulsed dye laser in treating vascular abnormalities. It must also be noted that a second pass of the facial area with a standard PDL handpiece is required to address superficial vascular conditions of the face. The second major technology innovation is high speed power supply switching which changes the way the total dose of laser light is delivered. In PDLs, each shot or pulse is made up of a series of "sub-pulses." Significant reductions in purpura were observed in many conditions when pulse dye lasers evolved from the microsecond pulse to the millisecond pulse. Just as important to consider is the structure of the pulse. Candela's classic Vbeam uses 4 sub-pulses of dissimilar distribution. Therefore, if the practitioner used 16 joules in a shot, the first sub-pulse could be at high energy, with the remaining 3 sub-pulses having less energy than the first. In short, these high energy "pulses" could contribute to purpura in some cases. This is true even with the long pulse durations of the classic Vbeam. In the new line of Vbeam products, 8 sub-pulses of even power are introduced. For example, if 16 joules are used, this would be comprised of 8 sub-pulses of 2 joules each. In this example the total energy

Compression Handpiece Concept

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Compression Handpiece and time are exactly the same as the classic Vbeam as mentioned above. However, the new pulse configuration delivers the dose in 8 low power sub-pulses of 2 joules each which are gentler to the targeted vessels. This is an important improvement in energy delivery for the dye laser which will reduce the occurrences of purpura, as the sub-pulses are more likely to be below the purpura threshold. The pulse sequence chart (right) illustrates this concept.

WHAT ARE THE DIFFERENCES BETWEEN THE THREE DEVICES?

Aesthetica ­ The device comes with the 7 and 10mm pigmented lesion handpieces. Also, it has a 7 and 10mm handpiece with integrated cryogen DCD cooling, as do all the Vbeam family of lasers. This is clearly the "laser photo-facial" design but may also be used on other areas of the body, especially the chest and hands. U.S. List Price: $69,900 with a 1 year warranty. Platinum ­ The Platinum is really the newest Vbeam for vascular applications and comes with the 3, 5, 7, 10, 12, and 3x10mm handpieces. This version does not feature the pigmented lesion handpieces. U.S. List Price $86,500 with a 2 year warranty. Perfecta ­ This combines all the handpieces of the Platinum with the 2 pigmented lesion handpieces of the Aesthetica. U.S. List Price $96,500 with a 3 year warranty.

Candela Vbeam II Pulse Sequence If your dye laser is old microsecond technology, or your lease is expiring, the Platinum makes sense. It makes even more sense if you already have an IPL with which you are satisfied. Perfecta ­ Perfecta is an ideal choice if you do not own an IPL and your dye laser is old microsecond technology, or your lease is expiring. This unit combines the treatment capabilities of both the Aesthetica and Platinum in a single unit. Understand that treating vascular malformations and other vascular conditions is for the properly trained physician. Dermatologists, vascular surgeons, and a few other specialties are typical users of the Pulsed Dye Laser. It is important to note that the effective depth of the 595nm

As of this writing Candela is offering U.S. customers the Perfecta at $69,900. The offer expires March 6, 2006. After that I am told the upgrade cost from Aesthetica to Perfecta would be $40,000, and an upgrade from Platinum to Perfecta would be $20,000.

WHICH PRODUCT IS RIGHT FOR MY PRACTICE?

Aesthetica ­ If you do not already own an intense pulsed light unit (IPL), then I would consider Aesthetica. The "photofacial" is perhaps the most popular light-based treatment in the aesthetic medicine. In many cases it will be less expensive to operate and at a price point of $69,900 is below that of many high end IPL's. Platinum ­ As mentioned earlier, the Platinum is the new Vbeam.

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wavelength of the pulsed dye laser limits its efficacy in vessels <.5mm deep. Therefore, the PDL is not considered a device for leg veins. Some superficial telangiectasias of the leg which are less than 500 microns can be resolved with the PDL. Sclerotherapy and the high-powered Nd:YAG are best at deeper vessels. Varicosities are best treated by vascular surgeons.

WHAT OTHER IMPROVEMENTS HAVE BEEN MADE WITH THIS TECHNOLOGY?

On-board Computer & Touchscreen Interface Utilizing the Windows CE operating system all three lasers have intuitive interfaces which allow the operator to select the type of treatment. After treatment type and Screen 1 - Selection of Treatment and Location location are selected, pre-set operating parameters then appear. The clinician may then choose to manually override these settings by touching up or down arrows. There are visual guides as well as treatment tips which appear as settings are adjusted. In essence, the systems have "built-in" trainers that make suggestions. I am sure this will evolve into a full- featured "expert system" as more clinical data is accumulated and programmed. Selection of Treatment and Location (Screen 1 - above left) is the first treatment window interface, and Selection of Treatment Parameters (Screen 2 - left) is the second window interface for selection of treatment parameters. USB Port Software upgrades can be made by simply plugging in a memory stick. The screen easily guides your Screen 2 ­ Selection of Treatment Parameters upgrade. Upgrades may include information such as treatment

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USB Port parameters, protocols or actually modifying the system operation: no service technician required! New Handpiece The newly designed ergonomic handpiece is much more comfortable than previous Candela handpieces. In addition, the distance gauges automatically detect the spot size for automatic calibration which is a great help. I tried connecting and disconnecting the distance guage myself and can say that it is a great improvement over the previous sliders. It is much easier to change and clean. External Water Reservoir This new external design simplifies installation, makes maintenance easier to reduce or avoid service calls, and generally removes all the headaches which surround internal water tanks. The unit will even tell you when it needs water! dye laser will appreciate this improvement. Treatment Summary The Treatment Summary Screen (Screen 3 - below) will allow you to review the last several treatments performed. This may be upgraded in the future to include patient treatment history; but since most MDs keep paper files, it may be redundant. In any event, it is sometimes helpful to review the treatment last performed for your charts. External Dye Pack External Water Reservoir

New Handpiece New External Dye Kits The new design allows the authorized staff to easily change dye packs. I really did not believe this until I tried it myself. On the first try I changed it out with only 2 minutes of training. The dye kits last 25% longer than the classic Vbeam while operating at 30% more energy. Anyone who has owned a pulsed Screen 3 - Treatment Summary

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3 Meter Fiber The longer 3 meter fiber cable has a support arm which keeps the fiber from dragging on the floor (where it may be damaged or a trip hazard) and reduces operator fatigue by supporting the weight of the cable. Password Lock-out This feature allows the unit to be password protected. The benefit is increased security from unauthorized personnel or patients from accessing the laser by using the traditional key method.

CONCLUDING COMMENTS

The pulsed dye laser is, perhaps, the most investigated aesthetic laser for superficial vascular abnormalities. Prior to the technical improvements of millisecond pulse durations, improved power delivery and epidermal cooling, transient edema, and purpura were common side effects. Historically, smaller spot sizes and lower fluences reduced these side effects but also decreased clinical efficacy. Other side effects include transient hypopigmentation or hyperpigmentation, particularly in

dark-skinned or tanned patients. The chances of these side effects are significantly reduced with the 8 micro-pulse structure of Candela's new Vbeam family of products. This fact, combined with precise cryogen cooling and updated protocols, should reduce even further these unwanted side effects. Technical advances in the pulsed dye laser will undoubtedly result in better clinical results and reduced side effects in treating vascular abnormalities. This, combined with the compression handpiece to treat pigmented lesions, makes Candela's new pulsed dye lasers a compelling choice for a medical aesthetic practice.

CLINICAL RESULTS

REFERENCES

Hand before (left) and After (right ) 1 Treatment, 10 J/cm2, 1.5 msec Photos courtesy of Jerome Garden, M.D. 1. Keller, G. S., Lee, P.K., Lacomb, V.G., Watson, J.P., Lasers in Aesthetic Surgery, pp 151-170, 2001 Theime Medical Publishers. 2. Alster, T.S., Manual of Cutaneous Laser Techniques, pp 33-51, 53, 70 2000 Lippincott Williams & Female Face Before (left) and 1 month After (right) 1 Treatment, 10 J/cm2, 1.5 ms, 7mm spot Photos courtesy of Taro Kono, M.D. Wilkins.

Female Face Before (left) and 6 weeks After (right) 3 treatments, 8 ­ 10 J/cm2, 10 msec Photos courtesy of Eric Bernstein, M.D.

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]

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