Over the last several years, physicians have been applying energy for skin tightening and other aesthetic corrections; yet, most devices still lack real-time feedback features that intelligently react to how much of that energy is reaching intended tissue targets. One manufacturer has dramatically raised the technology bar, giving physicians automated, intelligent guidance leading to better outcomes.
An innovative energy-based technology recently debuted in the form of two new medical devices from Lutronic Global (Billerica, Mass.) – the Genius™ and Clarity II™. At first glance, both systems appear to be upgrades to the Infini™ and first-generation Clarity devices, respectively. However, they have been completely redesigned with proprietary Intelligent Design for Intelligent Care™ technology, which was developed jointly by Lutronic’s U.S.- and Korea-based researchers.
According to Lee Pannell, the company’s chief operating officer, in developing these systems, “Not only did we study clinical ergonomics to provide lightweight handpieces and more intuitive user interfaces, but our new systems provide patented, real-time tissue sensing and intelligent tracking.”
Intelligent design
The FDA recently cleared the Genius radiofrequency (RF)-based microneedling platform, which addresses scars, skin texture, fine lines, wrinkles and laxity anywhere on the body by stimulating the regeneration of collagen and elastin.
This system incorporates “smart” features that provide additional feedback for physicians. These advancements include complex algorithms that thoroughly examine the patient’s skin hundreds of times per second, helping operators to deliver more consistent and efficacious energy during the treatment.
In addition, adjustable settings allow providers to optimize treatment based on age, skin type, amount of sun exposure, body area, tissue thickness and depth, and other variables. The system can also reproducibly increase dermal volume like never before.
The Clarity II was just unveiled at the March 2019 meeting of the American Society for Laser Medicine and Surgery (ASLMS). It has received Europe’s CE mark and South Korea MFDS clearance, and is currently pending FDA clearance.
This improved dual-wavelength platform combines 755 nm Alexandrite and long-pulsed 1064 nm Nd:YAG lasers on a single platform to address permanent hair reduction, pigmented and vascular lesions and other applications. The Clarity II comes with real-time temperature sensing, as well as proprietary Intelligent Tracking, which helps practitioners deliver faster, more consistent, efficacious treatment coverage while providing ongoing feedback regarding treatment endpoints.
“The company has stepped out of the box and did a great deal of histology research and clinical study,” stated Steven F. Weiner, MD, a facial plastic surgeon in Santa Rosa Beach, Fla., who also performed some of the Genius clinical trials for FDA clearance.
“They did not conform to what has been accepted as the norm in energy-based devices, but rather aspired to do better than that. With this fresh technology, increased safety was a primary concern, as well as overall efficacy,” he pointed out.
As detailed by Mr. Pannell, the new systems offer increased power, spot size, speed and other factors, while reducing pain and downtime. “That alone was no simple task to achieve,” he noted. “We went even further to provide the real-time information that can guide clinicians to deliver optimal outcomes. For instance, Lutronic Genius helps ensure that the amount of energy requested is being delivered accurately to the depth requested.”
Similarly, the Clarity II’s mechanisms guarantee that energy is delivered precisely at the requested coverage rate without too much heat. “These proprietary features can eliminate the need to perform test spots or take an ultra-conservative treatment approach,” Mr. Pannell added. “Other systems on the market cannot come anywhere close to this.”
Intelligent care
“Intelligent Care technology means practitioners can perform procedures more quickly and easily,” expressed Omar Ibrahimi, MD, PhD, a dermatologist and medical director at Connecticut Skin Institute (Stamford, Conn.).
“With the Genius, for instance, that means making sure each pulse is distributing the energy we want, and that the device is keeping track of the overall amount of energy delivered,” he continued. With the Clarity II, Intelligent Care means that the device is helping me deliver a more complete treatment in a way that is easier for me to perform while also achieving better results.”
Scott Gerrish, DO, medical director at Gerrish MedEsthetics (Vienna, Va.), welcomed the new Intelligent Care features when upgrading from the Infini to the Genius. “We had the Infini for about four years, and when the Genius became available we grabbed it. It is quite impressive. The main feature is the predictability of outcomes. The Intelligent Care technology gives you meaningful feedback as you’re using it and keeps you informed.
"Over the past four years, while the Infini has been a RF microneedling workhorse in Dr. Gerrish’s practice, “Temperature controls and feedback were often guesswork for the operator. While these older devices would just deliver whatever energy you set, the Genius not only dials in your settings, it can also alter how that energy is delivered in terms of the tissue response. Now we know exactly what it is doing.”
Cindy McClure, APRN-BC, owner of Southern Cosmetic Laser (Lodson, S.C.) has been a longtime Infini user and recently upgraded to Genius. She also employs two other Lutronic aesthetic devices in her practice, the LaseMD thulium-based laser and the Q-switched Spectra™ system. “Genius and Clarity II are definitely advancing the technology,” she noted. “The Genius’s smooth mechanization is quite advanced compared with other devices. It is a very smooth performer and delivers relatively comfortable treatments with much less downtime.”
Physician response to both platforms has been very strong, noted Mr. Pannell. “Physicians are really enjoying the ability to tailor the patient experience, whether that is maximum results, minimal pain, minimal downtime or all of the above. Reactions to Clarity II, in particular, are astounding, perhaps because laser hair removal is considered to be such a commodity. However, the multifunctional Clarity II platform not only rapidly treats hair, it also addresses pigmentary and vascular conditions just as rapidly and with unprecedented safety.”
Drilling down into how Intelligent Care technology is implemented among these systems, Dr. Weiner explained, “What Lutronic’s engineers did was go back to the drawing board to determine any variables that could possibly affect the results, with the goal of maximizing those variables.”
For instance, in the Genius, improvements were made to the microneedle configuration regarding sharpness and diameter, Dr. Weiner elaborated. “It comes with coated (insulated) needles and we can go anywhere from .25 mm up to 3.5 mm deep, treating the coagulation zone under the skin, which ultimately helps with wrinkles and skin tightening, as well as acne scarring.”
Next, the device’s motor was reengineered. “Its power has been maximized, as well as its speed. I can reach deeper depths more easily,” Dr. Weiner continued. “Then they looked into how the RF energy was being delivered and found that placing too much energy too quickly actually led to a termination of the energy pulse.”
Impedance improvements
Another technical challenge for Lutronic’s engineers was figuring out how the Genius could measure the impedance of different skin types on the fly.
“The Genius employs real-time feedback mechanisms to determine the best way to optimize energy delivery to the dermis,” noted Dr. Gerrish. “This is important because not everybody’s skin is the same. In fact, in areas of face the skin is different within the individual.
“Genius measures the resistance of the skin, called impedance, and adjusts to deliver the requested energy depending on the person’s skin resistance,” Dr. Gerrish explained. “The system feeds that information to the operator, so we can push in the exact amount of energy that is needed. We can deliver that in anybody’s skin, regardless of their hydration, thickness, the amount of collagen or amount of scarring.”
Therefore, unlike other RF microneedling platforms, the Genius’ technology delivers energy much differently, Dr. Weiner remarked.
“This is an entirely different concept from what one sees in other devices. Sometimes competing devices don’t actually deliver all the energy, because some bounces off the skin,” Dr. Weiner elaborated. “Maybe the needles aren’t sharp enough or the motor is not strong enough, or the operator does not press hard enough.
“Also, other systems may not apply the concept of delivering too much energy in a shorter period of time,” Dr. Weiner continued. “Instead, the energy will actually just cut off because the impedance goes way up. There is no way to deliver energy when the impedance is so high, and the resistance of the tissue cannot propagate the energy when it is that high. With Genius, all of these aspects are now built into the underlying technology, so we don’t run into those problems.
”The handpiece has also been updated, stated Dr. Weiner. “One thing you’ll notice about the Genius versus the Infini is a handpiece that is a lot slicker, more ergonomic. The problem we had before was that the tip was hard to see with the previous large handpiece. This has been corrected with the Genius,” he said.
Interface upgrades
The devices’ user interfaces have been upgraded, as well, added Dr. Weiner. “When we start a Genius procedure we dial the millijoules per pin into the system that we want to deliver, and then we do a test spot. We see how effective we were in conveying the energy and what energy was actually delivered,” he stated.
“In almost every case it will be exactly as you calculate, meaning 49 pins times the per-pin energy and that will give you the total pulse energy,” he explained. “We aim for anywhere from 0.5 J per pulse up to 2 J per pulse, and maybe even slightly higher to get to deeper levels of tissue. Then, we will usually do two to three passes per patient, again adjusting the energy according to the indication we are treating, whether it is aging, acne scarring, contouring of the jawline or working in the submental area. Each of these different areas get treated a little bit differently."
The software provides an easy-to-read feedback system during the procedure. “If the pulse you are giving is successful, then you see a green light. If you see a yellow light, the system is warning the operator that something is amiss. They could be moving the handpiece too quickly, or not being perpendicular to the skin or not pressing firmly enough,” Dr. Weiner shared. “Or, perhaps the tissue itself is too dehydrated or sun damaged to be able to accept the amount of energy that you want to send. You adjust according to that feedback,” reported Dr. Weiner.
The Clarity II operates via very similar parameters, Dr. Weiner conveyed. “As with the earlier Clarity system, the Clarity II operates on two wavelengths, but the delivery mechanism is completely changed. The new system uses a rolling mechanism to deliver the energy, so instead of doing pulses you roll the applicator along the skin and deliver pulses as you go.
”In addition, the Clarity II allows operators to adjust the rolling action to overlap. “Theoretically, you can go from 15% to 50%, for instance, and if you go within the prescribed speed range, you will get precise coverage every time. If you’re moving the applicator too fast, then the machine tells you that you need to slow down,” Dr. Weiner stated.
During treatment, the feedback system monitors skin temperature to the correct levels for all skin types, which is especially critical in darker skin where excessive heating raises the risk of inflammatory hyperpigmentation.
“As it turns out, because of all the changes to the underlying technology, the delivery of energy is actually more comfortable for patients, especially where RF microneedling is concerned,” Dr. Weiner revealed. “I don’t want to fool people into thinking that there is no discomfort at all when getting a Genius treatment. Patient discomfort is directly associated with the energy delivery. For patients that can tolerate a little bit of discomfort, you give more energy per pulse. For patients that cannot tolerate as much, sometimes you give more pulses, each with less energy.”
Increased patient satisfaction
Patient satisfaction has been high, noted Dr. Ibrahimi. “With the addition of Intelligent Care to the Genius, my patients have commented how much more comfortable the treatments are, while at the same time saying they feel the results are better. While the Clarity II is not yet FDA cleared, the test subjects I have treated all remarked how much they prefer this device to previous methods of hair removal.”
Dr. Gerrish noted that while using the Infini gave good clinical results, “Patients said the treatment could hurt. We had to numb everybody with injections of lidocaine, which was a barrier for some patients. Just the numbing injections could create bruises, which ultimately created more downtime.”
According to Dr. Gerrish, “The benefits of the Genius are the redesigned needles and the way the system delivers the energy. Now, patients have said the comfort level is much better. We use just a topical to numb the dermis. That was the really exciting part for us. It opened up the door for so many patients who were hesitant to get numbed with anything more than a topical.”
Increased patient approval levels relate back to the ergonomic improvements and advanced technological prowess developed in both the Genius and Clarity II, noted Mr. Pannell.
“Our research not only leads us to study the science of tissue interaction, but we really take to heart the physician’s experience and the patients’ outcomes,” he expressed.
Inspiring objectives
“While other companies simply set up distribution agreements for existing technology, Lutronic has gone the other direction,” Mr. Pannell stated. “In fact, one-third of our team is involved in our R&D efforts. These people are innovative, smart and enthusiastic to provide novel, completely-out-of-the-box products and solutions,” he said.
Ms. McClure has been impressed with how Lutronic not only offers top aesthetic solutions but also treats the provider well. “I’m really impressed with them,” she opined.
“When we have chosen any of Lutronic's devices, they have really gone out of their way to make sure that we have every customer support needed, be it technology related, marketing or clinical support,” she elaborated.
“I’ve dealt with quite a few companies and Lutronic definitely stands out as one of the best. Their devices have all been good, but the real success is the company itself. We can adopt the best device in the world, but if I don’t have the manufacturer’s support behind me, then it’s not something I want to promote.”
In Dr. Ibrahimi’s opinion, “Lutronic is ahead of the curve in recognizing that things like Intelligent Care can help me deliver better and safer treatments to my patients. When a device makes me look better to my patients, then I am going to be a fan of that device.”
Both the Genius and Clarity II are “Heads and tails above anything else on the market,” Dr. Weiner concluded. “I told the company that once the Genius was FDA-approved everything else would become obsolete, because it is now really difficult for the competition to say that they match up to what is available in both of these systems."
