Sponsored by Cynosure, LLC
Expanding the capabilities of the TempSure RF platform with a totally novel approach to body contouring, FlexSure from Cynosure, LLC (Westford, Mass.) is the world’s first wrappable radiofrequency (RF) applicator, a truly landmark innovation designed to provide deep-tissue heating for a uniform deposition of energy safely, rapidly and consistently. Conforming to the topography of the treatment area, the flexible six-segment pad can wrap around limbs or flanks. Realtime feedback automatically prevents overtreatment to ensure safety, maximizing energy delivery to achieve dramatic results with virtually no pain, in a quick 15-minute treatment. Once applied, the device does the rest and staff can leave the room – an obvious benefit in the COVID-19 era.
“Simply put, FlexSure is an automated touchless applicator that expands the already versatile 300 W, 4 MHz TempSure platform,” said plastic and reconstructive surgeon Regina Fearmonti, MD, of Alon Aesthetics Plastic Surgery and SKIN (San Antonio, Texas).
Regina Fearmonti, MD Plastic & Reconstructive Surgeon
Raminder Saluja, MD Director
Bruce Katz, MD Director
“TempSure itself offers safe, consistent and reliable treatments,” she continued. The TempSure platform features Therapeutic Logic Control (TLC) to effectively manage RF delivery, and best-in-class temperature sensing with feedback-driven control to ensure the safe, predictable and consistent deposition of energy in each of the variety of applications.
“And as an extension of the TempSure device, FlexSure is safe for all Fitzpatrick skin types, safe for use even in sunny summer months, and there is no weight restriction,” Dr. Fearmonti continued. “We can treat almost all individuals with this technology, all patients can benefit year-round. As a medspa owner, that is maximum bang for my buck when it comes to purchasing a device.”
“Unlike other devices, this applicator conforms to the patient,” said ophthalmologist and fellowship-trained dermatologic cosmetic surgeon Raminder Saluja, MD, director of Saluja Cosmetic and Laser Center (Huntersville, N.C.). “With competitor devices, the applicator is rigid, so the tissue must conform to the applicator.”
FlexSure increases the utility of the already versatile TempSure platform, which features four other specialized applicators. TempSure Surgical RF for simultaneous cutting and coagulation focuses energy for cleaner incisions, reduced bleeding and bruising, and faster post-procedure healing. TempSure Envi features three handpieces for remodeling collagen to reduce the appearance of wrinkles and lines. The gentle TempSure Vitalia applicator for feminine wellness increases local circulation and decreases pain and muscle spasms, featuring dual thermistors coupled with impedance monitoring to prevent arcing. TempSure Firm is designed for even, thorough heating via continuous monopolar RF, making it an ideal cellulite treatment. Each has additional capabilities and treatment indications as well. FlexSure rounds out the spectrum of offerings.
“Another way of looking at FlexSure,” according to Bruce Katz, MD, director of JUVA Skin & Laser Center (New York, N.Y.), “is considering it to be the natural evolution of TempSure Firm.” However, the applicator for TempSure Firm is not ideal for many applications because of its size. The wrappable, six-segment FlexSure applicator can treat limbs, flanks and other areas that may not be suitable for TempSure Firm. “With FlexSure, you are not just treating a flat surface in one dimension, you can treat in three dimensions because it wraps around or follows the contours of the surface.
“And what you needed a technician with a handpiece to do with TempSure, you can do hands-free in only 15-minutes with FlexSure, because once the applicator is properly placed, the technician doesn’t have to move a handpiece or babysit the device so you can leave the patient alone,” Dr. Katz added. “This is totally safe to do.”
FlexSure is a novel solution to an old problem: maximum safe delivery of energy through deep-tissue heating to get the best result, every time. “RF technology was a boom to the industry because of its ability to penetrate and heat safely with minimal side effects, while maintaining dermal barrier function and avoiding damage to surrounding tissue as well as underlying musculature,” Dr. Saluja explained. “Its ability to heat tissue in bulk and increase local circulation make it ideal for body applications. All of these characteristics are well-documented in the literature. FlexSure allows for the optimum placement directly on the treatment area, conforming to the patient’s anatomy for consistent delivery that is eminently predictable and reproducible.”
Two FlexSure applicator sizes are available: 250 cm2 and 360 cm2. RF energy with FlexSure is not emitted through all six mini-applicator segments, or ‘applicator zones,’ simultaneously. Instead, high-energy RF emission oscillates in sequence between the six applicator zones in a manner that uniformly heats the tissue to a depth of 15 mm rapidly, and maintains the temperature safely above the approximate 40° C therapeutic threshold for the 15-minute treatment. “This is where the power of the device comes in handy,” Dr. Katz said. “With 300 W you have enough power to produce high energy from these six applicators.”
“In a way, the sequential activation of the applicator zones every two seconds around the grid pattern mimics the in- motion technique of a clinician using an RF handpiece,” Dr. Saluja observed. “The difference is that the latter will always be operator-dependent and less consistent. Having a fixed applicator like FlexSure eliminates that entirely, to provide the most uniform heating possible.”
The safety and comfort afforded by the feedback-driven temperature control also plays a key role ensuring optimum delivery of therapeutic energy. “With FlexSure we can provide as much energy as possible to raise and maintain tissue temperature, confident that we won’t cause injury or undue discomfort,” Dr. Fearmonti noted. “This means we get the best treatment every time; you can’t overtreat, you can’t undertreat. It is why RF can be comfortably delegated to your aestheticians and team members in most, if not all states.”
Additionally, emission can be adjusted for each applicator zone independently, according to Dr. Fearmonti, and can even be turned off completely. “Though the FlexSure applicator reduces operator dependence ensuring standardized treatments among providers, it also allows customization of each zone to patient comfort and needs. It offers Standard and Advanced modes.
“Advanced mode allows me to adjust each of the six applicator zones to a specific temperature based on patient comfort, needs, or underlying anatomy,” Dr. Fearmonti continued. “This makes each treatment reproducible over multiple sessions, yet completely customizable for the patient. It is ideal for the periumbilical donut, lower back, medial and lateral thighs, the hooded skin above the knees and arms.” FlexSure is not used directly over the umbilicus. “Other sensitive areas include the axilla and upper medial thigh. In those cases, I can tune down the energy for those applicators and tune other applicators up, ensuring an optimal treatment experience.”
“Scar tissue in the treatment area tends to heat up more rapidly than surrounding tissue,” Dr. Saluja noted, “which can cause an uncomfortable hot spot for the patient. We can minimize this by adjusting the emission for that particular applicator zone.
“FlexSure’s treatment capabilities do not render TempSure Firm obsolete,” she added. “For sensitive areas one would avoid with FlexSure, or maximizing surface area coverage in an area such as the anterior thighs, I rely on TempSure Firm which also features a massage component to the handpiece that is FDA cleared for the temporary reduction in the appearance of cellulite.”
As Dr. Fearmonti pointed out, one advantage to FlexSure is that anyone can benefit from treatment. “A running joke in the industry is that the ideal patient is the one who needs treatment the least,” she quipped.
The device is also valuable in combination with other modalities. “I use it as an adjunct in between SculpSure (Cynosure) treatments and after tumescent liposuction,” Dr. Fearmonti said. “With liposuction we will wait until the cannula insertion sites have closed and stopped draining, then use FlexSure to facilitate tissue contraction.”
Technically, FlexSure could be performed the same day on a SculpSure patient, though Dr. Fearmonti avoids this. “In my experience, the subcutaneous heat effect of SculpSure may linger and make the patient more sensitive to heat from a subsequent RF treatment like FlexSure in the same area directly afterward, the same day, but it isn’t unsafe and others may do that,” she stated. “What I really like to do is alternate between SculpSure and FlexSure or TempSure Firm every three weeks. This gives ample time for tissue recovery and gets the patient into my office more often, where I have additional opportunities to talk about their treatment goals and suggest additional options that might appeal to them.”
A significant benefit of hands-free operation allows practitioners to get more accomplished per unit of chair time, Dr. Saluja suggested. “While I have FlexSure treating the body safely and effectively, without intervention, other treatments such as facials or injectables can be performed simultaneously. Patients love this, especially now because they want to maximize what they get done in a single session and have fewer sessions, but for the physician it means more revenue in that session.” One key to making that concept a success is to work with patients on pricing of related packages. “The patient is making you more money by allowing you to treat more in one visit, and it is nice to pass some of this onto the patient. It also provides incentive for patients to accept the idea. So it’s a win-win.”
Both veteran and new-to-practice physicians can creatively and profitably harness the capabilities of TempSure with FlexSure, Dr. Saluja pointed out. “Established physicians will find additional utility in adding FlexSure, and TempSure, to take their body contouring outcomes to the next level in an adjunctive role. And because it is so safe and easy to use, new practitioners can utilize all these capabilities to increase the diversity of their armamentarium confidently, as they learn to maximize chair time and profits while taking on new staff.”
The 2020 intervention of COVID-19 has had a massive impact on life in general, let alone the practice of medicine. Social distancing and masks aren’t enough when you have a practitioner hovering over the patient for any length of time; dental hygienists, for example, make their living doing just that, with open-mouthed patients, thus their risk of contracting COVID-19 is among the highest in the medical industry.
And within cities, where the bulk of aesthetic practices are based, the risk of a COVID-19 spike is high. “Patients are extremely sensitive to this,” said Dr. Fearmonti, “and they’re watching us. We’ve always been transparent about washing and sanitizing behaviors, we open things in front of them, and medical practice sterilization procedures have been honed over many decades, but nowadays this is even more important. It impacts patient confidence and the patient experience.”
All this makes the introduction of new technologies a dicey proposition – unless the treatment is inherently optimized for use in such circumstances, such as with FlexSure.
“Once the setup is complete, staff members need not be present. Patients can keep their masks on if they like. And instead of having an aesthetician or doctor hovering over you for 30 to 60 minutes, you have only as much contact as is required to begin therapy and once the 15-minute treatment is complete, to remove the applicator,” said Dr. Saluja.
In this simple process, the practitioner peels a protective covering from the body-side of the applicator and presses it into place, where it will stick securely throughout the session. “After that you just press start.” Early in the COVID-19 crisis, Dr. Saluja was able to continue IRB trials with the device because it was inherently easy to manage the patient load and minimize risk of infection.
For Dr. Fearmonti, whose Texas-based practice reopened mid-May, there hasn’t been much slowdown, so being able to keep up the pace has been essential in the face of standing guidelines for safety. “We can’t have patients waiting so we are constantly turning treatment rooms around, sanitizing and minimizing unnecessary contact. The additional protocols involved with many aesthetic offerings, such as topical anesthesia, make things problematic. With FlexSure, staff members can bring the patient in and get them going with minimal hassle, then leave them alone safely. When they are done, they leave, and we can quickly turn the room over for the next patient. This has been a highlight of our busy practice.”
“Remember that patient safety is always a top priority, reliable results always bring patients back and the demand for non-invasive body contouring is at an all-time high,” Dr. Saluja emphasized. “Despite COVID-19 we expect this demand to go up, but even with hassle-free, non-invasive solutions the industry is still results-driven. FlexSure, with the TempSure platform, is not only versatile and easy to use, it can provide those results and enhance your other body contouring treatments because tissue contraction is an important aspect of body shaping outcomes. Novel, powerful, safe and effective body shaping technologies like FlexSure are the thing to have, especially if you want to involve ancillary staff.”
Where is FlexSure going next? “Physicians are going to experiment to find out just where they can put the FlexSure applicator, for one thing,” Dr. Saluja speculated. “Also, I’m curious to find out if we can safely use more than one applicator at a time in a single session, which would be a real benefit.
“Having an extremely reliable device with multiple uses makes sense for an aesthetic practitioner or spa owner in these challenging economic times,” Dr. Fearmonti said. “That’s what initially drew me to the TempSure platform. I also believe disposable applicators and hands-free treatments are the direction we are moving in to ensure the safest environment for our patients and staff.”
Editor’s Note: This article is sponsored by Cynosure, LLC. Cynosure, LLC owns exclusive rights to photography. Use of photography without written permission of Cynosure is prohibited. Cynosure is a registered trademark of Cynosure, LLC. FlexSure is a trademark of Cynosure, LLC. The FlexSure applicators provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. Like all medical procedures, not all patients are suitable for the treatment. A qualified practitioner is solely responsible for evaluating each subject’s suitability to undergo treatment and for informing those being treated about any risks associated with the treatment, pre-and postoperative care, and any other relevant information. Individual results may vary and are not guaranteed. The FlexSure RF applicators are available in the United Stated and Canada only. Dr. Fearmonti is a paid consultant of Cynosure, LLC. Dr. Saluja is a paid consultant of Cynosure, LLC. Dr. Katz is a paid consultant of Cynosure, LLC.