ePrime FAQs

 

 

What is ePRIME™?

The ePRIME™ System from Syneron and Candela is a minimally invasive RF aesthetic device designed for the treatment of aging skin. It offers unmatched precision and control of energy to naturally produce new collagen, elastin and hyaluronic acid to predictably restore a youthful appearance.

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How does it work?

ePRIME inserts 5 pairs [multiple arrays] of 32º, electrically isolated, bi-polar RF needles 1-2 mm into the skin automatically from a single use cartridge attached to the ePRIME applicator handpiece.  Distinct, fractionated zones of thermal injury are created as RF energy is delivered into the deep reticular dermis for a specific period of time at predetermined temperature settings. Thermocouple wires inserted in each of the needles measures dermal temperature; thermal injury is assured as real-time temperature monitoring adjusts energy ten times a second to achieve target temperatures.  The resulting specific injury to dermal collagen causes the body’s naturally occurring cascade of healing responses, ultimately resulting in both neo-collagenensis and neo-elastogenesis.  Treatment variability is eliminated and the patient’s individual healing assured.

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What makes ePRIME different?

ePRIME is the first minimally invasive aesthetic device to precisely target and deliver RF energy directly into the deep dermis for dramatic tone, volumetric and elastic improvements of the skin.  Unlike other approaches that require multiple treatments due to uncertain energy delivery, you can be assured that ePrime will deliver the treatment temperature you specify in a single treatment.  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.

  • Real Time Dermal Temperature Monitoring for Precise Thermal Injury Control
  • Reduce Treatment Variability; Enhance Result Constancy between Patients
  • Improved Treatment Outcomes—Skin Tone and Laxity
  • Unique Treatment outcomes—Dermal Volume and Elasticity

With ePRIME, physicians can achieve more predictable results in a single treatment while providing a positive patient experience.  Here’s how:

  • Patient comfort – Unlike many other noninvasive treatments that cannot use local anesthetic because it interferes with the treatment, the ePRIME treatment can be performed with a local anesthetic.  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 delivered as with other technologies, and there is no need to deliver lower, less effective energy levels to avoid patient discomfort.
  • Results in a single, convenient treatment – Patients only need one treatment to rejuvenate their skin with ePRIME.  There is no need to schedule multiple office visits to repeat treatments in order to achieve results. That means greater convenience and profitability for the physician and less downtime for the patient.
  • Lasting results – The ePRIME treatment promotes the natural production of new collagen, new elastin and new hyaluronic acid over time to restore a youthful appearance.

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What is dermal heating and why is it so important? 

Experience have shown that achieving consistent clinical efficacy while maintaining patient comfort during treatment has long been a challenge for noninvasive RF systems.  Most users agree that existing RF, IR and other bulk heating approaches to address skin laxity produce variable results, with some patients experiencing significant improvement and others none at all.   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 and increased treatment constancy can reasonably be expected from this new technology.

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Can you describe the treatment in more detail?

Bipolar RF energy is delivered directly to the reticular dermis 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, physicians can–for the first time–select tissue temperature and treatment duration as clinical end-points vs. blindly applying a fixed dose of energy.  Energy delivery is precisely controlled based on real-time feedback from the sensors rather than subjective patient response.  As a result, treatments are customized for each patient based on their skin response, ensuring consistent clinical results. 

Layers of the skin

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What is the risk to the epidermis and/or dermal structures?

In addition to the integral cooling plate, the proximal of the needle shaft is sheathed in insulation to protect the top layer of skin during treatment.  Within the dermal layer of skin, bipolar RF energy takes the path of least resistance, bypassing and protecting key adnexal structures such as adipose tissue (fat cells), sweat glands, sebaceous glands, hair follicles. 

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Tell me more about the microneedles.

A sterile single-patient-use cartridge houses the microneedle 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 during treatment for optimal treatment control and effectiveness.  With ePRIME, physicians 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 customized for each patient based on their skin response, ensuring consistent clinical results.

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Tell me more about the “unique healing process.”

As histological studies have confirmed, ePRIME treatments result in a unique healing process that was the first to demonstrates neo-collagenesis and neo-elastogenesis, 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 and improvements in skin quality AND skin elasticity.  The improvement in skin tone and laxity resulting from increased volum and amrked elastin production IS unique to ePRIME

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How long does it take to perform a ePRIME treatment?

The ePRIME treatment is one-time procedure typically lasting 30-45 minutes, including pre-treatment anesthesia delivery.

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What is the downtime for patients? 

ePRIME is a quick and simple procedure performed in a physician’s office.  A local anesthetic is used to manage patient comfort, so patients can drive themselves home after the treatment.  There is also no long waiting period up front for topical anesthetics 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 treatment, patients typically return to usual activities the next day.  Any minor redness, swelling or focal bruising can be covered with makeup within 24 hours. 

  • The ePRIME treatment is one time procedure typically lasting 45-minutes.
  • Local anesthetic can be used, so patients can drive home afterward. 
  • The microneedles are half the size of those used to deliver neurotoxins (Botox), so patients recover from needle sticks in a few hours.
  • Patients typically return to usual activities the next day; any minor redness, swelling or bruising can be covered with makeup within 24 hours. 

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Are there any side effects?

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

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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 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 edema.

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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 anesthetic needle delivery versus ePRIME needle insertions.  Bruising associated with ePRIME treatments typically fade and disappear in 7-10 days.

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What about swelling?

Temporary edema 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 taking place.   Patients can continue with their lifestyle regardless.

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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.  If an exposed needle is observed after needle insertion, the practitioner should retract the needles immediately without calling for energy delivery.

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What is the patient cost for the ePRIME procedure?

We anticipate physicians will charge about $3000-$5,000 for the procedure, depending where they are geographically located. 

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

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

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How do results differ from other technologies?

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 can expect a lasting, natural, more youthful appearance from ePRIME.

It is important to remember that other than surgery, no other “skin tightening” 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 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 tightening 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 skin tightening equation.   Since ePRIME eliminates treatment variability, clinical outcomes must be based solely upon individual healing responses.

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Are ePRIME patients satisfied?

In multiple clinical studies, ePRIME satisfaction rates nearly always approximate 100%a survey from a clinical study of 100 patients across seven sites, 92% of patients indicated they were satisfied or very satisfied with the treatment results. 

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What clinical studies have been completed for this product?

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.

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Does ePRIME have FDA 510(k) clearance?

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

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What happens if the needles are placed too deeply?

They 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 needles extend into the subcutis layer, the RF energy 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 deep dermis.

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What happens if the 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 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.

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Are there disposables involved and what are their costs?

Because this is a needle insertion technology, single patient use cartridges have been designed to ensure needle sterility.  The ePRIME cartridges list price is $350/cartridge US.

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How long do the cartridges last?

The needles are designed to complete a full facial treatment (both sides of the face and submentally).

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How long do the needles stay sharp?

Individual needles in the 10 needle are specially beveled to maintain their insertion sharpness and maximize patient comfort.  Studies have show that ePRIME needles “dull” with each insertion up to 5 insertions and then maintain their relative sharpness for up to 500 insertions. 

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Are you guaranteeing results?

No, we are guaranteeing to deliver a thermal injury to the reticular dermis that has been shown to result in a unique healing response including  neocollagenesis and neoelastoegenesis.  We cannot guarantee an individuals patient’s healing capabilities.  But, unlike other tissue tightening approaches, we can promise that the thermal injury that other technologies are attempting to achieve will be achieved with ePRIME. 

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Syneron® manufactures and sells ablative and non-ablative medical aesthetic devices that use the patented elos technology with applications for treatment of wrinkles, skin, age spots, cellulite, acne, rosacea, hair removal, leg veins, spider veins, and much more.  elos technology combines radio frequency and light energies, and is sold to dermatologists, plastic surgeons, family practitioners and other physicians, aestheticians, and medical spa professionals around the world.