BB&T Contributing Editor
LAS VEGAS — The Aesthetics Show, sponsored by Medical Insight (Mission Viejo, California), was well matched to this city which promotes glamour and ageless appearance. But given the topic, the mix of attendees — about 750 — was somewhat surprising: about half aestheticians and support staff from hospitals, clinics and spas, the other half physicians.
This variety is the result of the interesting and critical range of medical specialists that perform aesthetic surgical procedures. This range recently has expanded beyond plastic surgeons and dermatologists to include gynecologists, ophthalmologists and primary care physicians.
They are frequently drawn to this field by the appeal of private pay patients — and thus not having to deal with the complexities of reimbursement — and the growing demand by an aging population for aesthetic procedures.
Here too is a wide variety of applications: hair removal, pigmented lesions and tattoo removal, facial rejuvenation, skin tightening, body contouring, smoothing of cellulite, and elimination of wrinkles. (See Table 5, next page, for numbers on commonly performed aesthetic procedures.)
The device end of this spectrum consists of a range of exhibitors and presentations focused on the use of lasers and intense pulsed light (IPL) for aesthetic procedures. Then add to this hi-tech range the many companies providing products in more conventional technologies, such as dermal fillers, breast implants and devices used for liposuction - this latter still not having developed its full hi-tech potential.
Lasers, fractional and otherwise
A growing emphasis at the conference was seen in “fractional” resurfacing. Fractional skin resurfacing uses a million points of light to treat damaged skin pixel by pixel, spot by spot; for a device to be defined as fractional, it must create microscopic spots less than 400 microns in diameter, which are barely visible to the naked eye.
• Reliant Technologies (Mountain View, California) pioneered the use of non-ablative fractional skin resurfacing to treat aging and sun-damaged skin, age spots and the smoothing of surgical scars and crepe-textured skin. Its Fraxel laser can be used anywhere on the body. The company has reported that a clinical trial is underway for use of the Fraxel laser to treat stretch marks.
The Fraxel laser creates an array of super-heated microscopic columns of thermal damage, called microscopic treatment zones (MTZ), with no need to cool the skin. Each MTZ is surrounded by uninjured tissue, permitting rapid healing and elimination of visible scarring. It offers the benefits of ablative skin resurfacing with minimal downtime.
Ablative fractional skin resurfacing products are sold by Alma Lasers (Buffalo Grove, Illinois and Caesarea, Israel), Lumenis (Santa Clara, California and Yokneam, Israel) and Syneron (Yokneam, Israel), and another is under development by Palomar Medical Technologies (Burlington, Massachusetts).
Alma Lasers is a two-year-old company that markets laser, light-based and radio frequency (RF) devices used for a range of aesthetic applications. It recently received FDA clearance for its Accent dual-mode RF system for wrinkle and rhytid removal and is in the process of getting approval for its use in body contouring and skin tightening. The company also sells 810 nm diode lasers.
Its Harmony laser is a modular system with 12 different handpieces for use in hair removal, skin rejuvenation, acne treatment, tattoo removal and for the treatment of vascular and pigmented lesions. The Soprano XL laser uses CW pulse technology for the homogeneous distribution of energy across the entire pulse. It is used for similar indications as the Harmony, including hair removal without a numbing agent. It has FDA clearance for use on all skin types.
Palomar markets the StarLux Platform that allows the attachment of several laser and pulsed light handpieces. The Lux 1540 and LuxDeepIR handpieces snap into its StarLux Platform and are used for non-ablative skin resurfacing, fractional skin tightening and soft tissue coagulation. They can also be used for leg vein treatment, permanent hair reduction, treatment of acne scars, and photofacials for pigmented and vascular lesions.
The pulsed-light handpieces use Palomar’s AccuSpectrum technology that emits light in the optimal bands of the spectrum to target specific chromophores and to filter out excess light to protect the skin. Palomar’s Q-YAG5 laser system is used for tattoo and pigmented lesion removal.
Cooltouch (Roseville, California) recently introduced its CoolLipo laser-assisted lipolysis treatment that photo-acoustically disrupts fat cells and causes collagen contraction and skin tightening, an effect not seen with standard liposuction. This minimally invasive procedure is performed by anesthetizing the treatment area into which a cannula, fitted with a laser fiber, is inserted. Treatment with light from a 1320 nm Nd:YAG laser liquefies the fat which is removed by a syringe or micro-cannula. The very short pulse length and high peak power allows fat to be ablated and liquefied with minimal side effects.
The company also featured at the show its CTEV 1320 nm laser for endovenous ablation of varicose veins, CT3Plus 1320 nm laser for acne, acne scars, and wrinkle treatments, and its Varia 1064 nm long-pulsed laser for hair removal from all skin types.
Cynosure (Westford, Massachusetts) markets the Smartlipo LaserBodySculpting workstation that is promoted as the industry’s first laser-assisted lipolysis system. It is designed to destroy fat cells and coagulate tissue for tissue tightening. It employs a 1064 nm Nd:YAG laser fiber that is introduced through a 1 mm cannula and delivers energy to subcutaneous fat cells, causing them to rupture and liquefy for removal by suctioning.
The laser also causes small blood vessels to coagulate immediately, resulting in less bleeding and trauma. Eclipse Medical (Dallas) has exclusive distribution rights to Smartlipo in the southern U.S.
Cynosure’s Affirm 1320 nm workstation was recently launched. It utilizes the company’s Combined Apex Pulse technology, a high density disposable lens array that redistributes laser energy in a combination of high and low level heat to stimulate and remodel collagen production throughout the treatment area. The Affirm is used for skin rejuvenation, treating wrinkles, acne scars, discoloration and tissue tightening as a result of collagen remodeling.
Focus Medical (Bethel, Connecticut) displayed its NaturaLase line of lasers including the NaturaLase QS, a Q-switched high pulse energy Nd:YAG laser, for hair removal, photo rejuvenation and removal of pigmented lesions and tattoos, NaturaLase Er, an erbium laser for skin resurfacing, and the NaturaLase LP long pulse Nd:YAG laser for wrinkle reduction and treatment of vascular lesions, leg and facial veins and hair removal.
NaturaLight is an IPL device for skin tightening, treatment of vascular and pigmented lesions, acne and hair removal.
EpiRay (Portola Valley, California) is working with Raydiance (Orlando, Florida), developer of an ultrashort pulse (USP) laser technology, for its use in removing tattoos.
USP lasers switch on and off at the incredibly high rate of once every femtosecond and can do their job without heating up surrounding tissue. Raydiance is also exploring the use of USP lasers for LASIK eye surgery since the heat caused by some lasers can cause harmful deformations in a patient’s cornea.
Byron, a business unit within Mentor (Santa Barbara, California), featured its products and accessories used for liposuction and body contouring. UltraSculpt is a recently developed lipoplasty device that uses ultrasonic energy to precisely target fatty deposits to gently liquefy fat and remove it from the surrounding tissue. The system provides the surgeon with the ability to select the ultrasound output mode and set pulse parameters to deliver precise vibration levels and offers accuracy that is not possible with conventional liposuction.
Recently, Mentor has partnered with Genzyme (Cambridge, Massachusetts) and Niadyne (Research Triangle Park, North Carolina) to develop a pipeline of science-based aesthetic products designed to rejuvenate every layer of the skin.
UltraShape (San Remon, California/Yokneam, Israel) markets Contour 1 which uses focused therapeutic ultrasound in a non-invasive treatment to selectively target and disrupt fat cells without damaging neighboring structures. It is an office-based procedure and requires no anesthesia or sedation. The majority of patients have reported no pain or discomfort and patients can immediately resume their daily activities. Maintenance treatments are not needed.
The system delivers measurable circumference and fat thickness reduction and incremental reductions with multiple treatments.
The Contour 1 system has been used in 30,000 procedures performed in over 250 clinics in 46 countries worldwide. The product is not yet approved in the U.S., but it received a medical device license from Health Canada in May 2007 for fat emulsification in aesthetic body contouring and is sold under an exclusive distribution agreement with Coherent-AMT (Cambridge, Ontario).
Also in May, UltraShape launched the Contour I version 2 system at the annual meeting of the European Academy of Dermatology and Venereology. The upgraded system features new software and a new illumination system to improve power management and performance of the tracking and guidance system.
Applisonix (Rehovot, Israel) is developing a product for hair removal that applies ultrasound energy directly to the hair which serves as an ultrasonic waveguide for channeling certain ultrasound energy to its root, where it is converted into thermal energy. As a result, the hair root’s temperature rapidly exceeds the level that generates long-term damage to the hair regrowth mechanisms.
Applisonix technology is expected to be significantly safer than laser/IPL because the energy is applied directly into the hair shaft and not irradiated over large skin surfaces. Unlike laser and IPL, Applisonix says that its technology is effective for everyone, regardless of hair color or skin tone.
The company recently reported completing the initial development phase of a clinical prototype for professional hair removal.
Sound Surgical Technologies (Louisville, Colorado) employs ultrasonic energy in its Vaser system. Small grooved probes are used to emulsify fat cells that are aspirated by massage for body contouring. The system allows for fragmentation of adipose tissues with minimal disruption to blood vessels and nerves, resulting in low to minimal pain and fast recovery.
Until last year, the Vaser system was sold only to plastic surgeons, but it is now also being marketed to general surgeons and gynecologists.
LipoSonix (Bothell, Washington) is developing an external body sculpting device by precisely focusing high-intensity ultrasound energy to cause thermocoagulation of adipose tissue. A custom designed ultrasound transducer delivers energy across the skin surface at a relatively low intensity, but brings this energy to a sharp focus in the subcutaneous fat. At the skin surface, the intensity of the ultrasound energy is low enough so that no damage occurs.
Once adipocytes have been disrupted, chemotactic signals activate the body’s inflammatory response mechanisms. Macrophage cells are attracted to the area to engulf and transport the lipids and cell debris. This results in an overall reduction in local adipose tissue volume.
Aesthera (Pleasanton, California) makes light-based aesthetic treatment systems based on photo-pneumatic technology (PPx). It featured at the meeting its FDA-cleared and newly marketed Isolaz equipment for painless and permanent hair removal, deep pore-cleansing acne treatment, removal of pigmented and vascular lesions, and skin rejuvenation of all skin types. It uses pneumatic energy (vacuum) and laser light to destroy bacteria that cause mild to moderate acne and acne vulgaris
Raja Medical (West Palm Beach, Florida) exhibited sapphire photoabrasion products. The Sapphire 3 and Sapphire Abrastim 200 systems combine lymphatic drainage and a vitamin exfoliation in a skin rejuvenation process. Named after the sapphire granules in its tip, the suction-free abrasion technique vibrates while it slowly passes across the skin surface to painlessly ablate the outer surface layers of the skin, resulting in improved skin texture, tone and appearance.
The lymphatic system is used to detoxify and regenerate new tissue and cells for maintaining a healthy immune system. It has no pump and depends on muscle contractions and deep breathing to drain properly. Sapphire 3 photoabrasion treats the skin with red monochromatic light to expedite the replacement of older or damaged skin. It also stimulates fibroblasts in connective tissue which produces collagen and promotes skin elasticity and firmness. A blue LED light is used for treating bacteria that cause acne.
An estimated 80% of women over age 20 have cellulite. The smoothing of cellulite has attracted a growing number of companies offering light-based solutions. Following is a sampling of other offerings at the aesthetics meeting.
Syneron (Yokneam, Israel) claims that VelaSmooth is the first medical device clinically proven to be an effective treatment of cellulite. It combines bipolar radiofrequency, infrared light and negative pressure.
SmoothShapes (Merrimack, New Hampshire) has developed the SmoothShapes 100 cellulite reduction system. It is a combination therapy that uses lasers at predetermined wavelengths in the visible and infrared spectra with vacuum massage to treat cellulite. It is indicated for the temporary reduction in the appearance of cellulite, as well as for the relief of minor muscle aches and pain, relief of muscle spasms, and temporary improvement of local blood circulation.
A multi-client clinical study on SmoothShapes 100 concluded that 81% of patients experienced significant volumetric reduction in subcutaneous fat. According to the company, 85% of women will develop cellulite as some point in their life.
DermaSweep (Rocklin, California) markets DermaSweep MD for multi-level skin resurfacing. It uses a wand with a nylon-tipped bristle to remove the stratum corneum and to prepare the epidermis to receive one of five different solutions that are infused into the skin (EpiInfused microdermabrasion).
Applications include the reduction of early aging lines, treatment of hyperpigmentation, photodamage, acne, and surgical scars. This process is more aggressive than microdermabrasion.
The DermaSweep Mini is a portable micro-resurfacing system. It is designed as both a stand-alone treatment and as an adjunct therapy for other modalities such as intense pulsed light (IPL) therapy or photodynamic therapy (PDT).
Evera Medical (Foster City, California) markets to plastic surgeons the VeraFil augmentation implant. It is a saline-filled silicone/ePTFE implant cleared for use in the periorbital region. The company plans to obtain 510(k) clearance for additional facial applications of the VeraFil device. Its FulFil soft tissue implant has CE Mark approval for soft tissue augmentation anywhere on the face. The products aim to create a natural look and feeling that is permanent but can be reversed.
Consumer aesthetics grows
The consumer aesthetic device market is viewed as a growth area.
Several home-use dermabrasion devices have been introduced in recent years. Palomar Medical Technology (Burlington, Massachusetts) has previously entered into collaborative relationships with Procter & Gamble (Cincinnati) for a home-use light-based hair removal device, and with Johnson & Johnson (New Brunswick, New Jersey) to develop home-use, light-based devices for skin rejuvenation, acne and cellulite.
Xthetix (Mesa, Arizona) is a startup company that is developing a handheld and battery operated device for treating and preventing acne and will be followed by products for skin rejuvenation and for treating inflammatory skin conditions.