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ENDYMED 3 DEEP® Study

At IML, we have performed a clinical study of the safety and effectiveness for treatment of patients affected by cellulite and flaccidity through the application of radiofrequency with the Endymed 3 Deep® device.

Endymed 3 Deep® delivers bipolar radiofrequency at 1 MHz, with an emission power of 1 to 60 watts in continuous transmission. Its handpiece is specially designed, it has three transmission electrodes and three receptor electrodes that generate electrical fields of the same polarity (multipolar radiofrequency) that confers greater penetrability than a typically bipolar delivery in which the penetrability is slightly less (1.5 mm in bipolar radiofrequency, 6 mm in multipolar radiofrequency with a 3Deep® handpiece). There is less flux on the surface and therefore superficial refrigeration is not necessary and the energy flows to the desired depth in a localised and contained way. The radiofrequency circulates between the transmission and receptor electrodes, confining all the density of delivery at a depth of 6 mm with no deeper transmission. Therefore, the density of local energy in the treatment area can be more efficient. The handpiece has a phase control system of the three transmissions which allow the penetration of heat at the desired skin depth without damaging the epidermis and with an impendence detector that allows delivery to adapt to the specific conditions of the treated skin. The continuous control of the dipole contact quality with the skin guarantees the homogeneity of radiofrequency entry, which avoids heat peaks due to excess concentration of density on small areas of contact between the electrodes and the skin. Impendence affects the diffusability of the radiofrequency in the tissues and not every body area or person has the same impendence in the treatment area. According to the impendence, the delivered radiofrequency energy needed to heat the tissue will vary, therefore the system adjusts automatically. Tissue heating is reached through the resistance given to the radiofrequency transmission (conductivity) based on Joule’s Law. Conductivity is conditioned by the frequency of RF delivery, the type of tissue and its density in water and its temperature. Therefore, it is of interest to optimise the ideal RF case by case.

ENDYMED 3 DEEP®

The handpiece controls its contact quality and its movement over the skin. Delivery is blocked if the movement is not fast enough and impendence is also monitored as well as the transmission time. There is no dependent technical variability if the technician respects the defined protocol.

For the study, a selection of 20 patients with flaccidity or cellulite (or both) on some body region was performed. Selection and inclusion criteria were applied (tables I and II).

Inclusion Criteria (Table I)

• Healthy men and women over 30
• Informed written consent was obtained
• Complete clinical follow-up commitment

Exclusion Criteria (Table II)

• Presence of arrhythmias or pacemakers
• Metal implants in the treatment area
• Recent intake of medication which could affect the skin’s response such as retinoic acid
• Patients having undergone invasive techniques in the treatment area in the last six months or to techniques such as laser hair removal
• Patients pending invasive techniques or laser hair removal over the period of the study
• Suspicion of a lesion on the area
• History of keloids or hypertrophic scars
• Pregnancy or breast-feeding
• Epilepsy or severe migraines
• Tattoos or body piercing in the area
• Infection, pain or abscess in the treatment area
• Eczema or dermatitis in the treatment area
• History of autoimmune alterations or diabetess
• Anticoagulant treatment
• History of coagulation disorders
• Subjects medicated without the adequate conditions to correctly follow the study
• Situations of extreme weakness
• Subjects with objections to the protocol
• Subjects participating in concurrent studies
• Medical criteria objection

The patients’ flaccidity and cellulite types were assessed using the Fitzpatrick scale on starting the treatment, after each session and three months after the final session given that the precise time needed to clinically observe the improvements of the new collagen formation requires a minimum of 3 to 6 months. Body contour measurements were taken for the area to be treated and the control area to remove the variable of potential weight changes that would also modify the control area. Pre and post treatment photographs were taken. In each session, the type of current cellulite was recorded, the scale of efficiency on the cellulite and the scale of efficiency on Tightening.

Cellulite degree table (Table III)

• Smooth skin, no depressions
• Discreet and limited depressions
• Presence of a moderate number of somewhat deeper depressions/li>
• Abundant number of depressions, some large over most of the skinl
• Cottage cheese appearance

Table of Cellulite effectiveness
(Table IV)

• No visual effect
• Subtle effect (less than 20%)
• Moderate effect (less than 50%)
• Significant (up to 80%)
• Broad (more than 80%)

Skin tightening efficiency (Table V)

• No visual effect
• Subtle effect (less than 20%)
• Moderate effect (less than 50%)
• Significant (up to 80%))
• Broad (more than 80%)

For the study, without the registration of technical-dependent variables, four nurses were specifically trained who performed the treatment protocol identically.

In each session, we divided the surface to be treated into grids with a standard surface of 10 x 10 cm2 or rectangles containing 100 cm2, depending on the shape of the area. The initial delivery intensity was selected, making sure it was tolerated by the patient but did not delay the temperature reaching pre-therapeutic level by more than 2 minutes. The delivery energy of the device oscillated in a range from 0 to 65 watts. Preheating typically started at levels around 35 w and was adjusted according to the time each area took to raise in temperature. Once the ideal power level was registered, this value was used for the next session’s preheating.

Pre-therapeutic passes were performed within the grid, with homogenous circular movements of varying diameter and exiting the passes 30% outside the grid to avoid under treated areas or cold spots within the grid. Furthermore, heat overlapping in some adjacent areas facilitates that all of the treated tissue act as a relative heat reservoir and the grids require less numbers of passes to reach the preheating as the session advanced. The treated surface is monitored to reach a minimum of 40 ºC on its surface, measured with an infrared detection laser thermometer. (CEM DT-880 Infrared Thermometer, B.)

The therapeutic session begins at this moment:

Eight, 30 second long passes are needed over the grid to assure a good deep heating. In the last passes, the patient feels quite hot but the increase in temperature is mild and the RF entry distributed on the skin with no temperature peaks that could interrupt treatment. The passes should be continuous to avoid that the grid cools down between passes.

The total energy of the therapeutic phase per grid and 30 second pass for currents selected between 35 and 40 w is 1050-1200 joules. After applying the 8 passes, the total delivered energy is 8400-9600 joules in each 100 cm2 grid. The total mean energy per cm2 is 84-96 joules.

The rest of the grids are treated in the same way.

In the cases in which the patients tolerate more than eight passes, the technician is instructed to increase the number of 30 second passes giving them more options to increase the treatment effect.

The area is warm and erythematous on ending the session and the localised heat sensation should be maintained for at least 30 minutes after the session to consider that it has been effective. This has been contrasted and proven with the results obtained from our second study.

According to our previous experience with RF (Accent®) treatments, we have considered that the minimum number of sessions should be eight. The first four would be weekly or bi-weekly and the final four proportionally spaced. There are areas where it may be of interest to set 12 sessions if there is a great deal of flaccidity.

Results are visible a few days after the first session. We have observed that results improve over time since neocollagenesis requires 3 to 6 months for the results to be manifest as improved skin quality.

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