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Science, Safety and Success Support the Rise of Dual-Modality Body Shaping Device

Article-Science, Safety and Success Support the Rise of Dual-Modality Body Shaping Device

Sponsored by Ultimate Contour Ultimate Contour from Ideal Curves LLC (Lehi, Utah) merges a uniquely delivered low-intensity, low-frequency focused ultrasound with radiofrequency (RF) to disrupt localized fat and smooth overlying tissue, giving aesthetic physicians the ability to deliver instantly visible results that bring patients back for more. This consumable-free device shifts the current standard for traditional body shaping devices to a new realm, providing substantial return on investment (ROI) as well as results.

Sponsored by Ultimate Contour

Ultimate Contour from Ideal Curves LLC (Lehi, Utah) merges a uniquely delivered low-intensity, low-frequency focused ultrasound with radiofrequency (RF) to disrupt localized fat and smooth overlying tissue, giving aesthetic physicians the ability to deliver instantly visible results that bring patients back for more. This consumable-free device shifts the current standard for traditional body shaping devices to a new realm, providing substantial return on investment (ROI) as well as results.

As the brainchild of John Meadors, DC, the idea for Ultimate Contour was planted in 2003 but did not germinate until 2013. After an exhaustive search for engineers with the vision to bring the idea to fruition, and rigorous FDA trials, Ultimate Contour was born.

“This is a great device for any dermatologist who wants to enter or build a presence in the body sculpting space,” said dermatologist Wendy Roberts, MD, who practices in Rancho Mirage, Calif. “Ultimate Contour is a great entry-level machine because the unit is small and on wheels, it is painless, easy and safe to use, and works well. It does what they say it will do. We haven’t seen major complications so far. The device is affordable, treatment is affordable for patients, you get noticeable results immediately and patients want more. If you have any kind of aesthetic practice, it is almost mandatory you have something for body shaping, and this is perfect for that.”

“To me, the most important thing about Ultimate Contour is that people are losing inches quickly and safely,” reported Michael Gold, MD, the founder and medical director of Gold Skin Care Center, Advanced Aesthetics Medical Spa, The Laser & Rejuvenation Center and Tennessee Clinical Research Center in Nashville, Tenn. “In an industry where you have to be careful about claims, this device is doing what they claim it does, safely. In my many years, I have seen technologies come and go because they simply didn’t live up to the hype. The bottom line is that Ultimate Contour works well and quickly, which is important in this space because these days patients want results fast.”

“The two unique aspects of this technology that I noticed outside of safety and efficacy, which will be very appealing to physicians, are the treatment comfort and lack of consumables,” explained Barry DiBernardo, MD, founder of New Jersey Plastic Surgery in Montclair, N.J. “Early technologies based mostly on ultrasound were not as comfortable, and Ultimate Contour is very comfortable in comparison. Secondly, we have no consumables, so we don’t need to pay a substantial cost every time we treat patients. The device itself is reasonably priced, but regardless, the cost of consumables on top of any capital outlay will cut deeply into your ROI, so lack of consumables is important for tracking practice profits.”

“This is another evolution of ultrasound for fat,” emphasized plastic surgeon Jason Pozner, MD, owner of Sanctuary Plastic Surgery (Boca Raton, Fla.). Dr. Pozner has been part of numerous FDA clinical trials, some with ultrasound modalities. “The early devices for tightening and fat reduction did produce results but were often associated with significant discomfort. Ultimate Contour does not have that discomfort, it is safe and seems to work well, and there are no disposables so the financial picture will be much more favorable. Also, we have not seen paradoxical hyperplasia or other adverse events that have been an issue for existing technologies for fat.”

Another physician with longtime involvement in the space is dermatologist and cosmetic laser surgeon Mark Taylor, MD, founder and medical director of Gateway Aesthetic Institute and Laser Center (Salt Lake City, Utah). “Early ultrasound devices were extremely painful; my staff really didn’t like using them because of the discomfort to patients, the cumbersome nature of the treatment and the mixed results. They absolutely love Ultimate Contour because the patients love it, and treatment is much easier to perform. I’ve owned every device ever made and the Ultimate Contour is the only device I highly recommend for body contouring,” he explained.

Coupling the strengths of its high-intensity ultrasound and RF modalities to disrupt fat and tighten skin, Ultimate Contour delivers a one-two punch against unwanted adiposity that is painless and without consumables. The low-frequency (40 KHz) ultrasound component – unique in the space – causes immediate lipolysis of underlying fat in the treatment area by sending disruptive vibrations that devastate the structural integrity of fat cells. Voids and pockets are created to further stress adipocytes to rupture. Resultant free-floating fatty acids and cellular debris are then eliminated via the body’s natural mechanisms. According to Dr. Taylor, the power and megahertz are what separate ultrasound devices. “Ultimate Contour’s unique combination of frequency and energy work together in the right way to shake the fat cells apart.”

RF delivers uniform deep-tissue heating at the deeper, collagen-rich skin layers to induce collagen contraction as well as promote neocollagenesis and neoelastinogenesis. Treatment is likened to a gentle hot-stone massage and lasts 10 to 15 minutes per zone. Beyond the abdomen, the RF component is also commonly employed to tighten arms, thighs and knees; both modalities can be used individually, but maximum results require both ultrasound and RF components with repeated sessions. A typical course of Ultimate Contour therapy is four to six sessions at one-week intervals.

Typical treatment with Ultimate Contour begins with visualizing four abdominal quadrants, each its own treatment zone (roughly the size of a half sheet of paper, according to Dr. DiBernardo). Ultrasound lotion is applied for lubrication and contact purposes, which also contributes to optimal energy absorption.

The user applies the handpiece to the lotioned area and works across as energy is applied, requiring about 20 to 40 minutes per zone depending on total surface area, usually related to BMI. Redness is typical but not persistent past a few hours and most patients report no pain. There is no downtime associated with Ultimate Contour. “This device glides easily over the treatment area so you can do four reasonably-sized areas in a typical 40-minute session,” Dr. Taylor continued. After treatment with the ultrasound component, patients can immediately resume daily activities, including workouts.

Remarkably, patients notice immediate circumference reduction after a single session, up to a full inch. As the body recovers and its natural waste removal and metabolic processes do their work, the full result typically manifests over a period of six to eight weeks from the initial treatment. Remodeling and growth of collagen and elastin also take time; skin tightening and cellulite improvement will occur gradually over a period no less than four weeks.

Rapid results are a huge hit with the Beverly Hills crowd, according to Ava Shamban, MD, director of Ava MD (Beverly Hills, Calif.). “The typical patient in Beverly Hills is not high-BMI, but everybody must look perfect or has some high-profile event to attend. With Ultimate Contour, you get those on-the-table results plus what happens over the next several weeks, and patients are over the moon about it,” she expressed.

“When we are treating people, we have to be careful to explain how the results will look, and the timeline,” Dr. Gold explained. “It will take weeks and weeks to see the full result, and four to six treatments. This has been true for a long time. With Ultimate Contour, the full result still manifests over that length of time, but the instant results require no explanation. They encourage trust and compliance, especially when you consider that the treatment is comfortable, so the patient not only comes back to complete a course of treatment, they tell their friends – or better yet, their friends ask them what they have been doing.”

Science, Safety and Success Support the Rise of Dual-Modality Body Shaping Device“I was hesitant to adopt previous body shaping technologies,” Dr. Roberts shared. “With my pathology background, I thought that there may be inherent challenges associated with treatment, some of which did surface. I felt the opposite when Dr. Meadors showed me Ultimate Contour because it was safe and easy to operate, and, in my opinion, it delivered well beyond the promises, which is not as common in this business as we would like it to be. It is safe and it works, what more can you ask for?”

“I must admit I was skeptical at first,” Dr. Gold related, “and we don’t fully understand why it works so well, but their proprietary ultrasound and RF combination has obvious synergy because the results are real, and the patient satisfaction is real. I have told myself it simply should not work as well as it does, but I cannot argue with the results.”

Researchers such as Dr. DiBernardo have shed some light. “We treated ten patients in a preliminary analysis of the device,” Dr. DiBernardo began, “with four sessions at one-week intervals; treatment times ranging between about 30 to 50 minutes depending on the size of the areas treated. We used FLIR infrared imaging to monitor heat and saw no excess heat, which is probably a contributing factor to the high relative comfort of treatment. Also, any major adverse events were absent at this point.”

Dr. DiBernardo said that according to ex vivo histology work done by Christopher Robb, MD (Spring Hill, Tenn.), there was a remarkable effect on the fatty tissue in the treatment zone. “Dr. Robb referred to it as the fatty tissue being ‘shredded.’ They were physically broken apart. I believe that is why we are seeing an effect right away. Speculation is that the larger ultrasonic waves are creating a physical disruption to the fat cell wall and total destruction of the fat cell. If you think about the waveform at 40 KHz, you are creating physical damage to fat cells. For more insight, we treated another specimen and looked at it at five-, ten-, and 15-minute treatment points with concomitant scanning electron microscopy at 10,000x magnification; serial images showed increasingly broken cells, providing further physical evidence of what is happening at the cellular level. We hope to do further multi-center studies to gain more insight into this promising technology.”

As-yet-unpublished FDA trials seem to agree. An investigation led by Thomas Sutton, MD (Lincoln, Neb.), treated about 50 patients for three sessions over a nine-day period; patients lost an average of 3.12 inches. A trial by Kirk Moore, MD (Midvale, Utah) revealed an average 2.0 inches lost by patients (N=50) after three once-per-week treatments, measured at 12 weeks out.

Ultimate Contour is also FDA cleared for the temporary reduction of the appearance of cellulite. Among many contributing factors to cellulite are body-fat percentage, skin thickness and quality, age, and that old culprit, genetics. “Cellulite is multifactorial, and, as everyone knows, we do not have a cure for it. However, we can treat it successfully with Ultimate Contour,” said Dr. Gold. “The keys are compliance, which you get in spades with Ultimate Contour, and maintenance, which is especially important with cellulite.” While not a permanent solution, the effects of treatment – localized fat reduction, skin tightening, improvements in elasticity and thickness, and enhanced local microcirculation – can dramatically affect the appearance of cellulite with time. “But again, the synergy between the proprietary ultrasound and RF of Ultimate Contour gives those immediate results. Theoretically, you get fat disruption from the ultrasound and some improvement in skin tightening and quality from the RF, which also helps the appearance of cellulite,” Dr. Gold added.

Adopting the device is a breeze. “As far as medical aesthetic devices go, this is one of the easiest to use, as well as very easy to teach and implement into your practice,” Dr. Pozner emphasized, “so you can delegate this treatment to staff. It depends on state and local regulations, but ultrasound devices are not as heavily regulated in most places as laser- or light-based therapies because those require much more training to use safely. Staff acceptance is quite high due to ease of use and time of the procedure.”

With any body shaping technology, ideal candidates are fairly slim and healthy, simply looking for something to help them achieve what they have not been able to from their efforts at the gym or the dinner table. However, Ultimate Contour’s low-frequency ultrasound is FDA cleared for abdominal circumference reduction in candidates with a BMI of 25 or greater, so somewhat heavier patients can benefit. “Ideal patients would be the low-hanging fruit – people with specific bulges or troublesome areas they want reduced, which have proven resistant to diet and exercise,” Dr. Pozner indicated. “It is also a valid post-liposuction adjunct to push those results to the next level.”

Dr. Taylor agreed. “Good candidates have localized pooches of fat that they just cannot get rid of at the gym or in the kitchen, and they just need a little shaping, typically around the abdomen, the love handles, perhaps the axilla or saddlebags,” he explained. “You can treat higher-BMI patients, but you have to manage expectations and get results that you are both going to be happy with, so one must be very careful treating heavier patients. That is true for any treatment, including liposuction, which is capable of treating individuals with a larger BMI.”

According to Dr. Shamban, safety and ease-of-use are key in an aesthetic climate more inclusive than ever to what are referred to as non-core physicians (not dermatologists or plastic surgeons). “As the aesthetic industry embraces the non-core physician, we are looking at two realities: the benefit of how they expand the industry, and the potential harm they can cause if patients are unsatisfied – or worse, get hurt. Claims of ‘easy to do’ can promote complacency. This device bypasses all that. Ultimate Contour is easy to use safely and will give you great results consistently with basic training. I mean, I just had my arms treated, and they look like they are airbrushed. Also, no consumables means that pricing is not complicated; it can be based entirely on what your regional market will bear above your simple overhead.”

As with all aesthetic contouring devices, Ultimate Contour is not a weight-loss solution meant to replace diet, exercise and other aspects of a healthy lifestyle. However, according to Dr. Roberts, it is the perfect stepping stone to lifestyle improvements because the results are so motivating.

“As a physician, I want to positively impact the health and wellbeing of my patients as much as possible, so I always suggest changes in lifestyle components such as diet and exercise. We can get results with Ultimate Contour without lifestyle changes, but as with any body contouring treatment, a closer-to-optimal lifestyle leads to closer-to-optimal outcomes that last longer,” Dr. Roberts expressed. “The immediate and longer-term results are so motivating, we would be missing an opportunity if we didn’t share that information with patients. Maintenance treatments are always important as well, of course, but Ultimate Contour motivated me to push harder with my own diet, hydration and exercise, and I am always eager to share the good news with my patients. I offer body composition scales and nutritional programs to support any patient who wants more, and with Ultimate Contour it is that much easier.”

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