ePRIME equipemnt

ePrime is the first minimally invasive aesthetic device to precisely target and deliver measured Radiofrequency(RF) energy directly into the deep parts of the skin achieving a youthful rejuvenation via significant tone, laxity and volumetric improvements of the skin in a single treatment.


How does it work?

Diagram of how ePRIME works

The applicator handpiece on the ePRIME device inserts 5 pairs of very fine, electrically isolated, bi-polar Radiofrequency(RF) micro needles 1-2 mm into the skin automatically from a single use cartridge. Distinct, individual zones of thermal injury are created between each pair of the ePRIME needles as Radiofrequency(RF) energy is delivered into the deeper parts of the skin for a specific period of time at predetermined temperature settings. Specialised sensors inserted in each of the needles measures the skin temperature. Thermal injury is assured as real-time temperature monitoring adjusts energy ten times a second to achieve optimal target temperatures. The resulting specific injury to the deeper parts of the skin causes the body's naturally occurring cascade of healing responses to be initiated, ultimately resulting in both new collagen and new elastin production which helps increase the thickness of the skin, whilst also improving the elasticity and firmness of the skin . Due to the precision of the technology deployed, treatment variability is eliminated and the patient's individual healing is assured.

What are the micro needles?

ePRIME micro needles

A sterile, single-patient-use cartridge houses the ePRIME micro needle array of 5 pairs of 32 gauge electrodes—similar to those used to deliver neurotoxins (Botox). Sensors within the electrode tips continually measure tissue temperature and impedance (resistance) during treatment for optimal treatment control and effectiveness. With ePRIME, we can-for the first time-select tissue temperature and time-at-temperature as clinical end-points. Energy delivery is precisely controlled based on real-time feedback from the sensors rather than subjective patient response. As a result, treatments are automatically customized for each patient based on their skin response, ensuring consistent clinical results.

What happens if the micro needles are placed too deeply?

The ePRIME micro needles are designed not to (at a 20° angle, the target is 1-2 mm into the dermal layer of the skin) but admittedly, the thickness of skin does vary from patient to patient. Studies have shown even when the micro needles extend into the subcutis layer(layer beneath the skin), the RF energy from the ePRIME system will continue to follow the path of least resistance (lower impedance in skin vs. fat) and most of the energy will still ultimately be deposited into the deeper parts of the skin.

What happens if the micro needles are placed too superficially?

The ePRIME system is designed to recognize differences in impedance and will adjust the energy being delivered accordingly. Superficial insertion is associated with low tissue impedance. In such a case, the ePRIME system is design to detect this situation, and shut down the RF energy to protect the epidermal layer and prevent superficial heating / burning. If the needles are repeatedly extended into the air, for example, the ePRIME console will recognize infinite impedance and identify a cartridge failure and therefore cease the treatment.

Is the ePRIME treatment painful?

Because there is a need to use the micro needles to deploy the RF energy from the ePRIME system effectively, local anaesthesia is used so that the procedure can be performed painlessly. Of course there will be a stinging sensation whilst the local anaesthesia is administered throughout the face, although every attempt will be made to minimise this through careful technique. However, once the local anaesthesia has been injected no further pain will be felt when the ePRIME treatment is actually performed.

Who is the ideal candidate for the ePRIME procedure?

The ideal candidate for the ePRIME procedure is typically someone who has some mild to moderate degree of skin laxity that wants to improve his or her skin firmness and volume and perhaps is not fully ready clinically for a skin tightening procedure such as a face lift. Patients who have more advanced levels of skin laxity are best dealt with via face lift procedure. Nonetheless patients with more advanced and obvious laxity of the skin-but who have already ruled out an invasive surgical face lift may also benefit from the ePRIME procedure. However these patients will need to understand that the ePRIME procedure in these circumstances will never mimic or achieve the results obtained with a surgical face lift.

How should I set my expectations?

It's important for patients to understand that although the revolumising effects from the new collagen and elastin production in the skin from the ePRIME treatment will improve skin laxity and some lines and wrinkles, it is not as obvious an effect or a substitute for a surgical face lift. As a very rough rule of thumb and for comparative purposes, it probably delivers approximately 25% of the effects of a surgical face lift. Therefore patient must adjust their expectations accordingly. The aim is for an improvement in firmness and laxity of the skin but it does not give the exact similar lifting effects that a face lift does. All expectation and limitations, as well as your suitability will of course be discussed at the consultation with Mr. Karidis.

Can you describe the ePRIME treatment in more detail?

As mentioned previously, bipolar RF energy is delivered from the ePRIME system directly to the deeper dermis(deeper layer of the skin) using an innovative micro-needle electrode array that bypasses the epidermis (top layer of skin) and papillary dermis (upper 1/3 of dermal layer). Electrical impedance (resistance) is checked and sensors within the electrode tips continually measure tissue temperature and during treatment for optimal treatment control and effectiveness. With ePRIME, we can therefore–for the first time–select tissue temperature and treatment duration as clinical end-points vs. blindly applying a fixed dose of energy. Energy delivery from the ePRIME system is precisely controlled based on real-time feedback from the sensors rather than subjective patient response. As a result, treatments are automatically customized for each patient based on their skin response, ensuring consistent clinical results.

What is dermal heating and why is it so important?

Dermal heating is an important concept in rejuvenation. All skin tightening devices work via a similar mechanism. By delivering enough heat from the ePRIME system through RF or light based energy deep into the dermis, they create a "unique healing process" through both mechanical and biochemical effects that lead to an initial contraction of the collagen fibers followed by a well-documented wound response with dermal(deep skin) remodelling and ultimately new collagen formation. This will successfully deliver enough energy from the ePRIME system deep into the dermal tissues to cause an effect. However, the skin must also be sufficiently be cooled prior to, during and after the ePRIME treatment.

Experience has shown that achieving consistent clinical efficacy while maintaining patient comfort during the ePRIME treatment has long been a challenge for non-invasive RF systems. Most users agree that existing Radiofrequency, Infra red and other energy based systems bulk heating approaches to address skin laxity produce variable results, with some patients experiencing significant improvement and others none at all. The ePRIME treatments uniquely deliver more energy deeper into the skin than competitive, bulk heating and non-invasive fractional devices, which studies have shown result in greater dermal volume and improved skin elasticity. Since treatment variability is eliminated with ePRIME, improved treatment outcomes can reasonably be expected from this new technology.

Tell me more about the “unique healing process”.

ePRIME skin

As histological(tissue) studies have confirmed, ePRIME treatments result in a unique healing process that was the first to demonstrates, not only new collagen but also new elastin production, which helps to explain the observable improvement in not only skin tone and volume but also increased skin elasticity, extensibility and pliability. ePRIME treatment results can be described more in terms of dermal volumizing(skin thickening) and improvements in skin quality AND skin elasticity. The improvement in skin tone and laxity resulting from increased volume and marked elastin production is unique to ePRIME.

What makes ePRIME different?

Up until now with the existing energy based machines such as the ePRIME system, energy used to heat the skin to stimulate new collagen formation has been primarily surface deployed. The problem was that although a certain amount of energy was released onto the outer surface of the skin, it was never quite certain what precise amount of energy was actually getting into the deeper parts of the skin to stimulate the collagen production. By using the aforementioned fine needles however, ePRIME is the first minimally invasive aesthetic device to precisely target and deliver specific and precise RF energy directly into the deep dermis for significant tone, volumetric and elastic improvements of the skin. Unlike other approaches that require multiple treatments due to uncertain energy delivery, a practitioner can now be assured that ePRIME will deliver the treatment temperature they specify in a single treatment. Furthemore, ePRIME's patented Intelligent Feedback Systems (IFS) measures impedance and monitors temperature real time to constantly adjust power levels regardless of varying skin conditions or skin types.

Moreover, unlike many other non-invasive treatments that cannot use local anaesthetic because it interferes with the treatment, the ePRIME treatment can and must be performed with a local anaesthetic. This allows optimal treatment temperatures to be reached to achieve results while managing patient comfort. The patient's response to pain is not used to determine how much energy is to be delivered, as with other technologies, and there is no need to deliver lower, less effective energy levels to avoid patient discomfort. With ePRIME it is also possible to achieve more predictable results in a single treatment while providing a positive patient experience.

What is the risk to the epidermis (top layer of the skin) and/or dermal structures?

The design of the ePRIME system has been developed to minimise risk to other structures. In addition to the integral cooling plate, which cools the surface of the skin, the inner end of the needle shaft is sheathed in insulation to protect the top layer of skin during treatment. Furthermore, within the dermal layer of skin, bipolar RF energy takes the path of least resistance, bypassing and protecting other key structures such as adipose tissue (fat cells), sweat glands, sebaceous glands, hair follicles.

What areas of the face and body can be done with ePRIME?

ePRIME treatment

All the studies and initial trials that have been done for the ePRIME treatment have been on the face and neck regions. Nonetheless, and according to the manufacturer, there is no reason why other parts of the body such as the arms, abdominal or knee skin, might not benefit from the ePRIME treatment. It's just that no formal studies have been done yet to prove its effectiveness.

How long does the ePRIME treatment take?

The ePRIME treatment is a one-time procedure and to perform the treatment on the face and neck typically lasts approximately one hour, including pre-treatment anaesthesia delivery.

What can I expect in the immediate post treatment period?

After the ePRIME treatment, you could expect to see some surface damage to the skin, which looks like lines of pin pricks. Your face will be puffy and tender throughout the first day gradually becoming tingly and sore- ice packs however will help to ease this. You may experience some itchiness and pain along the jaw bone and around the front of the ear area. This can take a while to ease. Oral painkillers usually suffice to help this. Intermittent bruising and yellowing of the skin may occur throughout the forthcoming days also along with a hot sensation and itchiness. Bumpy uneven skin and tenderness in the lower areas of the face may also be evident and cause you discomfort.

In the first few days after the ePRIME treatment there may be small pimple like spots, which can be sore and itchy and look like chicken pox in the treated areas. The swelling can take some time to subside and is especially evident from the 3rd to the 7th day-when you smile you will particularly notice this as this manifests itself predominantly around the mouth area. Bruising can be kept to a minimum by taking arnica pre and post procedure however you may develop small bruises or a yellowish hue in your skin tone which you may wish to cover with make-up in the first few days after the ePRIME treatment.

Where is ePRIME usually performed?

ePRIME is a quick and simple procedure usually performed in a doctors office. A local anaesthetic is used to manage patient comfort, so patients can drive themselves home, if they wish, after the ePRIME treatment. There is also no long waiting period up front for topical anaesthetics to take effect. The system uses microneedles that are half the size of those used to deliver neurotoxins (Botox), so patients recover from the needle penetration almost immediately. After the ePRIME treatment, patients typically return to usual activities the next day. Any minor redness, swelling or focal bruising can usually be covered with makeup within 24 hours.

Are there any side effects following the ePRIME treatment?

The ePRIME treatment has an excellent safety record and the treatment is usually well tolerated by patients. The fractional (specifically targeted) treatment approach protects the tissue surrounding the treatment zones. Side effects are generally mild and include redness, superficial bruising and swelling.

What about bleeding?

Since we are subjecting the skin to multiple needle insertions, some bleeding is to be expected. However, any bleeding that occurs during the ePRIME treatment procedure itself should resolve by the time the procedure is completed. Post-treatment care typically includes the use of an anti-microbial ointment that will also help keep the treatment area moist and the use of cool compresses to minimize post-treatment swelling.

What about bruising?

Again, since we are subjecting the skin to multiple needle insertions, some bruising may occur. With that being said, most of the bruising observed after ePRIME treatments has been attributed to the anaesthetic needle delivery versus the actual needle insertions. Bruising associated with ePRIME treatments typically fade and disappear in 7-10 days.

What about the swelling?

Temporary oedema or swelling is almost always observed following an ePRIME treatment. The amount of swelling experienced depends on the individual patient. Most physicians consider the swelling an indication that the normal healing process, which is generating new dermal tissue, is starting to take place. Obvious swelling may last up to 10 days in some patients. After this time it is generally much less noticeable. Patients can continue with their lifestyle regardless.

What about burning/blistering?

Blistering has only been observed if the needles are not fully inserted into the skin. When the ePRIME needles are fully deployed, only the needle insulation should be visible to the practitioner and therefore will be certain that the needles are deployed properly. If an exposed needle is observed after needle insertion, the practitioner will retract the needles immediately without calling for energy delivery.

When will I see results and how long will they last?

Following the ePRIME treatment, most patients report seeing improvement 6-8 weeks post treatment. Because however new collagen requires time to fully develop, optimal results will not be observed for at least 3 months post-treatment.

As occurs of course with all anti-ageing treatments, time never stands still. As a result you will continue to age according to the laws of time and physics, and of course on your lifestyle and skin maintenance routine. However it would be safe to say that after receiving most successful treatments you will always look somewhat better than you would have looked had you never received any such treatment!

How do ePRIME results differ from other technologies?

As already mentioned, the ePRIME treatment triggers a surge of growth activity within the dermis to significantly increase skin thickness and volume. While patients are excited to see improvement in their skin tone within several weeks, the production of collagen continues typically for up to 6 months or more. Patients therefore can expect a lasting, natural, more youthful appearance from ePRIME.

It is important to remember however that apart from surgery, no other treatment approach actually "tightens" the skin. All light-and energy-based technologies can only induce an injury to the skin, which should initiate a healing response that ultimately leads to an improvement in skin laxity. What separates ePRIME apart from all of these other skin tightening technologies is our ability to consistently deliver a fractionated(specifically focused) zone of known thermal injury specific to the deep dermis, where the potential for new collagen and elastin production has been demonstrated. The only variable left in the skin rejuvenation equation with ePRIME is the patient's healing response—some patients will just respond differently than others, regardless of the technology. With all other light- and energy-based approaches, the treatment technology itself remains a variable in the this equation. Since ePRIME eliminates treatment variability, clinical outcomes must be based solely upon individual healing responses.

What clinical studies have been completed for the ePRIME?

Five peer reviewed studies have been published on ePRIME with a sixth study expected to be published in 2011—

  • Bipolar fractional radiofrequency treatment induces neoelastogenesis and neocollagenesis (Lasers Surg Med; 41:1‐9, 2009), Hantash BM, Ubeid AA, Chang H, Kafi R, Renton B.
  • Pilot clinical study of a novel minimally invasive bipolar microneedle radiofrequency device (Lasers Surg Med; 41:87‐95, 2009), Hantash BM, Renton B, Berkowitz L, Stridde BC, Newman J.
  • A Predictive Model of Minimally Invasive Bipolar Fractional Radiofrequency Skin Treatment (Lasers in Surgery and Medicine 41:473–478, 2009), Dany Berube, PhD,* Bradley Renton, PhD, and Basil M. Hantash, MD, PhD
  • Blinded, randomized quantitative grading comparison of minimally-invasive fractional radiofrequency and surgical facelift for the treatment of skin laxity (ARCH DERMATOL/VOL 146 (NO. 4), APR 2010), Macrene Alexiades-Armenakas, M.D., Ph.D. , David Rosenberg, M.D., Bradley Renton, Ph.D., Jeffrey Dover, M.D., Kenneth Arndt, M.D.
  • Elastometry and Clinical Results Post-Bipolar Radiofrequency Treatment of Skin (Dermatologic Surgery 2010;36:877–884), Andrea Willey, M.D., Suzanne Kilmer, M.D., James Newman, M.D., Bradley Renton, Basil Hantash, PhD., Suhas Krishna, MS, Scott McGill, Dany Breube, PhD.

Does ePRIME have United States FDA 510 (k) clearance?

ePRIME has two FDA indications for use-- in dermatologic and general surgical procedures for electrocoagulation and hemostasis and for the ePRIME treatment of wrinkles.

It also has CE approved marking.

Are ePRIME patients satisfied?

As with many treatment modalities there are always variables that can affect ultimate result and therefore satisfaction rates. No treatment modality consistently gets 100% satisfaction rates. However in multiple clinical studies, ePRIME satisfaction rates are usually above 90%. In a recent survey from a clinical study of 100 patients across seven sites, 92% of patients indicated they were satisfied or very satisfied with the ePRIME treatment results.

Can you guarantee results with the ePRIME treatment?

In a word No. There are very few certainties in life and unfortunately medical treatments are not one of these. It's important to remember that whilst ePRIME is separated from all other skin rejuvenation technologies by its ability to consistently deliver a specific zone of thermal injury to the deeper skin layers, enabling the well documented and recognised potential for new collagen and elastin production, the only variable left in the skin rejuvenation equation therefore is the patients healing response-some patients will just respond differently than others, regardless of the technology. Unfortunately therefore we cannot guarantee individual patients healing capabilities nor is there any way we can predict this from the outset.

What ePRIME is guaranteeing however, is the ability to deliver a specific and well-monitored thermal injury to the deeper skin layers that has been shown to result in a unique healing response including new collagen and elastin formation. Unlike other tissue dermal heating approaches, we can however promise that the thermal injury that other technologies are attempting to achieve will definitely be achieved with ePRIME.

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