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Radiofrequency device offers new delivery algorithm, faster treatments

Article-Radiofrequency device offers new delivery algorithm, faster treatments

Thermage FLX® is the latest iteration of the popular radiofrequency-based Thermage skin tightening system from Solta Medical, a division of Bausch Health (Bothell, Wash.). Representing a major upgrade over previous versions, the Thermage FLX offers increased patient comfort and larger treatment spot sizes that reduce procedure time. In addition, a new, optimized energy delivery algorithm automatically measures and adjusts the amount of RF-based heat being delivered to the treatment area.

“RF energy is definitely widely accepted now as one of the best treatments that we have for skin laxity and to perform skin tightening. Thermage FLX is just the next generation of this technology, which makes it a better, more efficient and certainly easier treatment to add to a practice,” said Anne Chapas, M.D.

Like its precursors, Thermage FLX non-invasively delivers heat energy deep within the dermis to tighten and remodel existing collagen, as well as stimulate neocollagenesis.

Having received FDA clearance in October 2017 for non-invasive smoothing of skin on the face, eyes and body, Thermage FLX is commonly used to lift brows and tighten forehead skin; as well as treat under the eyes, on the cheeks, mid-face, jaw line and the neck. Body contouring applications include tightening in the abdomen area and reducing the appearance of cellulite.

The difference from earlier versions is that Thermage FLX simply does it better, faster and more comfortably, according to Mary Lupo, M.D., a dermatologist and clinical professor of dermatology at Tulane University School of Medicine in New Orleans, La.

“It is indicated to address the full face and body, but it works tremendously around the periorbital area, including the eyelids,” she said. “It is the only FDA-cleared device out there for working inside the orbital rim. In addition, it works very well on the body. The new body treatment tip is just fabulous.”

While the system still includes the company’s proprietary Comfort Pulse TechnologyTM (CPT), which utilizes vibrating pulses in the handpiece to enhance patient comfort, the unit’s treatment tips have been redesigned to deliver more uniform distribution of RF energy. This leads to improved patient comfort as the heat is more evenly dispersed within the treatment area.

For Susan Van Dyke, M.D., a der- matologist in Mountain View, Calif., the Thermage FLX is a lot more of an improvement than she expected.

“One thing we noticed right away was the bigger treatment tip,” she noted. “At 4 cm in size, it really speeds up the treatments and makes it more pleasant for both the operator and the patient.”

Handpiece vibration, which in previous Thermage iterations would often fatigue operators, is much better with Thermage FLX, Dr. Van Dyke added.

“Instead of a jackhammer feeling, the new handpiece features more of a side-to-side vibration. The older model was a little harder on the hands, but the new hand- piece is much more ergonomic, easier to hold and a lot better for me during the procedure, as well as the patient.”

In Dr. Chapas’ experience, the combination of less vibration in the handpiece and a larger tip size has cut down on the treatment times without compromising efficacy.

“At first, I felt like the treatment should be taking longer, but with Thermage FLX it goes so quickly,” she began. “This is because I was used to the older system, where the tip was about the size of a postage stamp; now, it is about the size of a half dollar. It moves along quite quickly whether you are treating the face and neck, doing a stomach treatment, or addressing bony surfaces or the eyelids. This is just one of the core improvements to the system.”

Patient comfort levels are significantly better than any other skin tightening technology, noted Vic A. Narurkar M.D., F.A.A.D., a dermatologist and derma- tologic surgeon in San Francisco, Calif. “We don’t have to use any anesthesia with Thermage FLX. It is to the point where patients that have used other skin tight- ening devices and procedures to tighten the skin now only want to use Thermage.”

“We’ve come a long way from when a Thermage treatment was considered painful,” Dr. Chapas agreed.

“When applying the first version of Thermage, we used to give people narcotics. We would have to really be cheerleading people through the whole procedure,” she said. “The Thermage CPT version changed that and introduced better, safer treatment protocols. Patient discomfort is almost a non-issue with the new device.”

A significant highlight is the FLX’s patented AccuREPTM technology, which provides operators with per-pulse adjust- ments of RF delivery for enhanced treat- ment precision and predictability.

“AccuREP is truly groundbreaking technology,” Dr. Narurkar remarked. “It autosenses the temperature, so every pulse is an active pulse. In effect, you get real- time feedback from the skin to the device.”

In general, non-invasive skin tightening can be very unpredictable and results can vary, expressed Suzanne Kilmer, M.D., a dermatologist in Sacramento, Calif., and clinical professor at the University of California, Davis.

“With AccuREP, the treatment can be more uniform among patients and more effective for each body area, which is a step towards more predictable outcomes.”

“Thermage has always provided a very natural skin tightening effect, but with Thermage FLX, the predictability of results has really increased, and you also see more dramatic results no matter where you treat – face, head, neck, eyes or body,” said Dr. Narurkar.

As reported by Dr. Van Dyke, “Previously you would have to tune the device once, maybe on the forehead, but the impedance on the forehead may be nothing like the impedance on the cheek or some other area, and we would have to stop and recalibrate every time we went to a new area.”

With Thermage FLX’s real-time impedance measurement, “The treatment literally starts as soon as you place the handpiece on the patient,” said Dr. Chapas. “There is no need to tune the system and the hand- piece like we used to. It is constantly reca- librating automatically to keep delivering uniform energy to each area, so there is less interruption with this system.”

“The precise impedance tuning is something that we wanted to introduce nearly 20 years ago, but just didn’t have the technical know-how at the time,” expressed Michael S. Kaminer, M.D., a cosmetic surgeon in Chestnut Hill, Mass., who has used Thermage since 2000. “Thermage FLX is simply better than the previous generation CPT platform.”

“I was initially skeptical as to whether FLX would be a good addition to our practice. However, I have been pleasantly surprised by the positive responses we have received from the many patients we have treated,” he added.

According to Dr. Kilmer, the unit’s cooling system also works to ensure patient well-being throughout the procedure. “It helps with comfort and consistently cools the skin before, during and post-pulse,” she explained. “The new cryogen canisters are also supposed to be less harmful to the environment. On the downside, they tend to need to be changed around every treatment and a half.” 

With all the improved features, physicians noted that results are overall better with Thermage FLX.

“Outcomes seem to be better on the face, with more tightening for the average patient, and more patients are seeing very noticeable improvements,” Dr. Kaminer emphasized.

“My sense is that results per patient have improved, and we obtain better outcomes on a higher percentage of patients,” Dr. Kaminer shared. “In our practice that percentage exceeds 98%. We are also seeing better results on the arms, abdomen and legs with the 900-pulse tip.”

Dr. Van Dyke has observed, “some really amazing results on post-baby tummies. We also use Thermage FLX as a standalone on the buttocks and have been doing a lot of cellulite reduction proce- dures that we combine with Thermage FLX. A lot of patients come in for cellulite treatments and have skin laxity on their anterior thighs as well, which is another area where we like to use Thermage.”

Combining Thermage FLX with other modalities is quite common, noted Dr. Narurkar. “Thermage works synergisti- cally with other procedures. I often combine it with injectables, as well as Fraxel and Clear + Brilliant. The combination of Thermage and Clear + Brilliant produces enhanced results that look like what you might get from BOTOX.”

Patients are thrilled with Thermage FLX treatments, Dr. Narurkar pointed out.

“Patient satisfaction is at a very high level,” he asserted. “Universally, they see results right away and that the best results come at around two to three months later, or even a little bit sooner than that.

“We are up to one year tracking our Thermage patients, as well, to determine the long-term results, and they still look good,” Dr. Narurkar continued. “There are a lot of RF devices out there and copycat systems that require multiple treatments. Thermage FLX requires just a single session.”

People see around 10% of the result right away, post-treatment, confirmed Dr. Chapas. “So, initially and right after the procedure patients comment on the encour- aging results,” she noted. “The remaining 90% of the result will take approximately three to four months to be visible.”

Dr. Chapas said strong word-of-mouth keeps people coming in, too. “Patients are hearing about it from other patients and their friends.”

Dr. Kaminer’s patients have been extremely happy with Thermage proce- dures for many years. “Having said that, satisfaction has definitely increased with the FLX platform,” he stated.

“New patients are pleased that they achieved both tightening and prevention of skin laxity and other indications. Existing patients who’ve had Thermage with previous-generation technology often com- ment that they observed more tightening and saw results sooner with FLX, compared to prior treatments,” he explained.

Dr. Kilmer has had a similar expe- rience, “Multiple patients who have been treated with both the old and new Thermage systems have said that with the FLX platform they see the effects sooner, and feel they see better results overall.”

Patient selection goes a long way towards achieving good outcomes, Dr. Kaminer added. “This is an essential element of patient satisfaction with Thermage FLX,” he emphasized.

“Satisfaction exceeds 98% when patients areproperlyselectedandeducatedastothe extent of improvement they might see, as well as the preventive benefit we routinely see when Thermage is performed every two years,” Dr. Kaminer added.

The news about Thermage FLX gets even better when it comes to return on investment (ROI), Dr. Narurkar claimed. “ROI is excellent. We are very busy with this device and do one or two cases per day, and I’m guesstimating 250 treat- ments so far in just one year,” he said.

Dr. Chapas put a fine point on the sub- ject, stating, “Thermage FLX is one of those devices that literally anybody can benefit from, and we are reaching a wide range of people from their mid-30s to the early 60s,” she reported.

“The treatment is not just for someone that is concerned about their face and neck,” she continued. “We do a lot of eyelid and abdomen treatments, as well. Many of my consults are with people that have concerns about other body areas. We use it all over the body. The FLX system offers much faster procedures that we can offertomorepatients.”

In Dr. Van Dyke’s practice, ROI has improved significantly due to the ability to treat larger areas quicker.

“My consumable cost is better and I’m treating a larger area faster. As a result, my time or my P.A.’s time is reduced. If the time spent on treatments is even 30% faster, then that is a real improvement.”

“As a physician, what you want first is a device that is safe,” Dr. Lupo underscored. “Second, the device needs to deliver an effective treatment; and third, you want a device that will give you decent ROI. That’s the order of importance for me, and I tell people that despite the advantageous ROI, the business of medicine foremost is to take good care of your patients.”

Thermage FLX is a great investment, echoed Dr. Kilmer.

“We do treatments regularly in our office,” she stated. “Patients will usually get treated annually, and sometimes twice per year. The FLX procedure takes less time, and Solta has outstanding customer service. Whenever there is an issue with the device, they address it in a very timely manner. The company is on top of it, which makes it easy for us.”

Solta has a track record of good service and providing solid clinical research on their systems, which is valuable, noted Dr. Lupo.

“I like the research that is behind the Thermage FLX,” she opined. “The company is doing their due diligence. This is not always the case with device manufac- turers. Some of them just do not put in the time to research and validate their devices.

They kind of throw it in the practitioner’s hands, leaving it up to us to figure out how to use the devices, and sometimes there are no guidelines or guidance.”

In the RF-based skin tightening arena, Thermage is the gold standard, Dr. Lupo added.

“If you are going to do one treatment that is going to make a big difference, then you do Thermage. It is backed by a company that is principled and does business in a responsible way. I admire the company’s work ethic and have observed its integrity, in general, and the science being employed.”

Dr. Van Dyke acknowledged that with Thermage FLX, Solta has been proactive and responsive to the needs of physicians.

“I was part of the advisory board several years ago, when the company’s developers were conceptualizing what features or advancements would make the Thermage system even better,” she recalled.

“This was before Solta was acquired by Valeant Pharmaceuticals. However, even after the acquisition the company con- tinued to absorb the recommendations of myself and others. And I’m pleased to report that they listened to some of the input that we gave them and have incorporated those features into the system in a really good way.

“Faster treatment time was important to us, and increased patient comfort was also essential,” Dr. Van Dyke continued. “For instance, the cryogen system that was added to the platform has been working very nicely and provides that increased comfort and speed. People wear down if they are under a treatment for 90 minutes. With Thermage FLX, you can do a whole face in less than an hour. I call that really responsive.”

“The system is better overall,” Dr. Kaminer concluded. “The handpiece now has a faster and better vibration for more comfort, and the precise energy delivery and tuning per pulse is huge.

“Plus, it is new technology, which our patients absolutely love,” he added. “For my staff and I, it is reliable with an easy- to-use interface that also offers comfortable ergonomics. Thermage FLX contains many important upgrades in the technology compared with prior generations.”