Sponsored by Cynosure, Inc.
The groundbreaking PotenzaTM radiofrequency (RF) microneedling device from Cynosure, Inc. (Westford, Mass.), provides all the capabilities of monopolar and bipolar RF treatments in a single platform. With novel needle technology and other features unique to this device – the world’s first FDA-cleared four-mode RF microneedling system – it elevates expectations of what RF microneedling treatments can achieve, allowing researchers and physicians to further explore its therapeutic capabilities and better serve the growing skin revitalization market.
But first, COVID
With the COVID-19 crisis affecting the lives of millions around the globe, altering the landscape of the economy and causing a lot of uncertainty about the future, Cynosure is committed to continuing its operations and assisting its partners and customer base in any way it can.
A variety of initiatives have been launched, including an online educational platform, to provide continued support. Cynosure University features a library of resources available for access at any time. This includes information on best practices, clinical training and information, marketing tips, product demos and more. Webinars featuring industry experts are being added at a rate of two to three per week, available live or on-demand, with topics such as how to stay connected with patients during times of crisis, how to stay engaged with your staff, the art of body contouring and the clinical application of its devices for users of all skill levels.
“We at Cynosure recognize that this is a challenging time for everyone, and we know that COVID-19 is having significant personal and economic repercussions on our consumers and customers,” said Cynosure CEO Todd Tillemans.
“In these uncertain times, we are taking the opportunity to reevaluate what we are doing and how we do it, and to reconnect with consumers and affirm the trust we’ve worked so hard to obtain over the years,” Mr. Tillemans continued. “We are also grateful to be in a position to advance our customer support structure with Cynosure University, which is helping to inspire and educate our customers and to improve patient outcomes. While we are all operating in uncertain times, Cynosure is ready to support our customers to come out of this situation even stronger and more prepared for the future.”
A new normal
As physicians and practitioners begin to rebound and return to a degree of normalcy, they will find that the landscape of RF microneedling has dramatically changed for the better with the introduction of Potenza. This system provides unrivaled capability to treat all skin types anywhere on the body, and because it is not light-based it can be used any time of year.
But there is much more to the story than that, said Dianne Quibell, MD, medical director of MD TLC (Wellesley, Mass.) and assistant clinical professor of medicine at Harvard Medical School (Boston, Mass.). According to Dr. Quibell, Potenza combines all the capabilities of monopolar and bipolar RF, and then some.
“RF is not new to the marketplace, but what is new is the versatility associated with Potenza,” she explained. “You have monopolar and bipolar RF together in one device, at frequencies of 1 MHz and 2 MHz where most other devices only have 2 MHz available. The industry has moved away from monopolar RF somewhat, which in my opinion subsequently means we are missing out on some of the benefits of that technology. Potenza users will have both at their disposal, each with different capabilities. I’ve held off on adopting RF microneedling technology until now because I was waiting for this device.”
As with all RF microneedling devices, Potenza uses ultra-fine needles to deliver thermal energy which, combined with the microneedle injury, causes tissue coagulation and stimulates the body’s natural healing processes to generate new collagen and elastin.
“Broadly speaking, RF microneedling devices as a group are tools to help revitalize skin with various types of conditions,” said dermatologist David McDaniel, MD, of the McDaniel Laser & Cosmetic Center (Virginia Beach, Va.).
“The needle diameter, depth, RF frequency and energy parameters are key factors used in the various therapeutic treatment protocols. These vary by both the skin disorders being treated as well as the differences in the various devices,” he elaborated. “Potenza creates a controlled thermal effect which standardizes energy delivery, monitored by measuring impedance. The device is unique in that it offers four modes: two different frequencies (1 MHz and 2 MHz) in both monopolar and bipolar modes.”
RF is all about electric current, which flows from the positive to the negative. Monopolar RF provides one pole and requires a grounding pad, while bipolar RF delivers more concentrated, superficial treatment as energy passes between needles. Monopolar delivers energy in a more generalized, less intense fashion and to deeper levels of tissue. Higher frequency energy is more quickly absorbed by tissue. Energy absorption also depends on tissue type and water content.
“Depth of energy delivery is determined by factors such as the needle depth, the choice of monopolar or bipolar mode (or combinations of both modes), number of passes and energy parameters,” Dr. McDaniel noted. “These allow customization for a patient’s specific disorder as well as anatomic variation in skin thickness. There is also a fairly extensive selection of microneedle arrays to choose from, which are defined in the Potenza treatment protocols.” The software also provides up to 20 customizable presets allowing users to save and recall treatment parameters for different areas.
Potenza features two handpieces, the motor handpiece for needle array tips, and the AC handpiece for single-needle tips. There are nine tip options in all. “It may seem daunting to have so much versatility and so many different needle tips if you are a beginner, but during the clinical trials I became very grateful to have so many needle tip configurations available,” Dr. Quibell reported. “There are times where I want 16 or 25 needles, but sometimes I want the greater density seen with a 49-needle array.”
Traditional insulated needle arrays, as well as the Tiger Tip are each available at densities of 16, 25 and 49 needles. Square tips treat an 8x8 mm area. Insertion depth can be adjusted between 0.5 mm and 4.0 mm. “There are no non-insulated needles with Potenza. If I were going to use a non- insulated needle I’d opt for a fractional laser instead,” Dr. Quibell stated.
“As an industry we are familiar with the concept of ‘density’ from fractional laser therapy, and different needle arrays give you density choices, but it works a little differently with RF than lasers,” Dr. Quibell clarified. “Higher needle density at the same energy output means less heat per needle, which I’ve found to be extremely useful on abdominal skin, where we get skin tightening through soft tissue coagulation and deep dermal heating. I like the 25-needle array on something like the neck, which has thinner skin, and for more challenging cases, I’ll go for the 16-needle array. Many devices don’t have this kind of flexibility of needle density.”
According to Dr. Quibell, using higher density arrays at depth is a great way to avoid post-inflammatory hyperpigmentation (PIH), and the deeper settings available to Potenza users facilitate this. “Even with a color-blind device like RF microneedling you want to be sensitive to this because you can treat too closely to that key area associated with PIH,” she asserted. “With Potenza’s insulated needles going deeper into the skin, past the dermal-epidermal junction, you can avoid causing PIH. This allows me to treat anyone year-round, anywhere on the body, which is important to me because when you rely on lasers you have to be even more careful of solar exposure. In my region, in the summer months, business slows down because nobody wants to be treated with a laser if they can’t go outside and enjoy the summer weather. I expect to see this change in the coming years because I can offer a valid alternative.”
Unique to Potenza is the single-needle tip for precision treatment of individual blemishes in depths of 0.8 mm, 1.2 mm and 1.5 mm, Dr. Quibell expressed. With a single needle, it is operated only in monopolar mode.
“There is beauty in simplicity, and this is an intuitive choice that makes sense to a laser person like me,” Dr. Quibell began. “I used to rely on lasers to treat individual lesions, but Potenza offers me a valid alternative for blemishes. I have actually used this to resolve blemishes; you can almost feel the char happening beneath the skin and unless you are not aggressive enough in your settings, you will only need one treatment. I’ve been able to close these down very nicely with single needle RF; it is a one-and-done treatment for those where I’ve had limited success with lasers. This turns Potenza from a skin revitalizing unit into a precision instrument.”
Another key novelty is that the speed of needle insertion can be adjusted, according to dermatologist Robert Weiss, MD, medical director of the Maryland Laser, Skin, and Vein Institute (Hunt Valley, Md.). “This device is highly advanced and allows for more individualized treatment. Adjusting needle insertion speed, for example, is valuable for successfully treating skin in different areas. We’ve found through general microneedling research that more rapid insertion is beneficial for treating acne scars, but a gentler, medium speed insertion is better for revitalizing skin of the neck; as the needle is inserted it stretches the skin for a cleaner microwound, which is important because the character of neck skin is completely different from that of an acne scar, which requires a more aggressive motion to fully penetrate and get to the full depth of the scar.”
“The repetition rate of insertions using the various tip configurations is also adjustable,” he continued. “This can increase treatment speed when the user – if they are comfortable with it – can make passes moving the handpiece faster along the skin at a higher repetition rate. Or, it can be used to modulate the number of insertions in a treatment area at a static speed of movement.” The cyclic rate of needle insertions, or repetition rate, is adjustable between 0.5 and 3.0 seconds, at 0.1 second increments.
When the current public health crisis has passed, growth of the vibrant skin revitalization market will recommence and RF microneedling is among the most popular methods of rejuvenating the appearance and staving off the visible signs of aging skin, and with good reason. “The appeal of RF microneedling is that it is simple, combining relatively benign puncture wounds with application of heat at depth for a trouble-free skin revitalization treatment,” said dermatologist Emil Tanghetti, MD, who practices in Sacramento, Calif.
“We get surface treatment of the skin with bipolar modes, and deeper effects with monopolar that will manifest over time. With varying degrees of topical anesthesia, we can treat more or less aggressively, depending on the condition and the patient’s tolerance for downtime,” Dr. Tanghetti asserted. “Recovery and down-time are minimal with RF microneedling, which patients always look for in a treatment. And a series of three to four hassle- free treatments is easy to work into one’s busy lifestyle; you can go back to work that day or the next. It also lends itself well to combination with other modalities, including lasers and IPL, for thorough treatment and better overall results. This is a great device for exploring new possibilities.
“With expanded capabilities and so many treatment parameters to adjust, we can more thoroughly explore what can be done with RF microneedling – a very valuable asset to the medical aesthetic community,” he continued.
“Histology has shown some of its effects on tissue, but isn’t all-revealing because we have been testing more around the lower-level settings,” Dr. Tanghetti pointed out. “The thermal effect is not always easily discernable, but this isn’t a bad thing because it does not take much to cause the desired therapeutic effect, which is always preferable. There is also the effect of the epidermal injury to be considered.”
Dr. Tanghetti reflected on the study of PicoSure® (Cynosure). “We discovered that the purely epidermal wounding alone caused a notable therapeutic effect, thus it is a key part of skin revitalization.”
Perhaps the most novel and exciting feature of Potenza is Tiger Tip technology, which treats tissue at multiple depths simultaneously using semi-insulated tips; each is insulated at the tip and in bands leaving two non-insulated portions along the shaft.
“Normally you might do two passes at different depths to treat the full thickness of the tissue. Most of us in the industry agree that we achieve a better outcome by treating multiple levels of tissue, particularly for skin revitalization. The more we can effectively stimulate the healing response at different depths of the dermis, the better. Potenza treats at two levels which theoretically eliminates the need for a second pass, so you can achieve these better results in less time with fewer passes overall,” said Dr. Weiss.
The true potential of Tiger Tip technology has yet to be revealed, stated Dr. Tanghetti. “Because we have been focused on lower-level settings where histology is not as useful of a measuring tool, it should not be our only guide. The before-and-after photos are the big show, especially at lower settings which have the advantage of being less aggressive, but still very effective for many indications. We’re still collecting a lot of data and I’m very optimistic about what we are finding as we dig deeper.”
“We are still exploring what can be done with the 2 MHz setting, but early data shows more heat is being applied,” Dr. Weiss confirmed. “Based on my experience and education, as more data is collected using higher energies I think we’ll see benefits for treating scars, for example, where more heat applied over the same period of time may yield better and more rapid improvement. Again, this is theoretical, we’re still gathering data.”
The Potenza potential
The Potenza’s unique value proposition is combining the ability to treat using existing knowledge about RF microneedling, with the opportunity to delve deeper into the capabilities of RF technology.
“The Potenza device offers flexibility to customize treatments using present protocols, and with four modes it enables versatility for the future evolution of RF microneedling therapies that are yet to be defined,” said Dr. McDaniel.
“There is a lot of interesting research being conducted around the world with the various brands of RF microneedling devices. I personally would like to see more understanding of the histopathology and the cell signaling that is produced short- and long-term by the various devices and treatment protocols,” he continued. “My research team is currently working on an IRB clinical study which involves skin biopsies that I hope will give us greater insight into how the Potenza device can be taken to the next level of therapeutic customization, and perhaps lead to additional clinical applications.”
“With Potenza, it is nice to know we have a device from a credible company with a reliable, growing body of science behind it,” Dr. Tanghetti added. “We’ve seen the first generation of RF microneedling devices, this is the next iteration and allows us to learn from the lessons of the past and explore new avenues of treatment in the future.”
“I want to be first to market in my area if the technology is sound, but when you are an early adopter you may find yourself buying the wrong device,” Dr. Quibell said. “I’ve been that doctor before, and sometimes the answer isn’t a software upgrade, it is an entirely separate device. Potenza is everything RF microneedling is supposed to be, in a single device, and we’ve only scratched the surface of what it can do.”