About ePrime Safety

ePrime Safety Proven in Clinical Studies

ePrime Safety FAQs

About ePrime Safety

ePrime is an energy-based dermal remodeling system that provides plastic surgeons and advanced aesthetic dermatologists a minimally invasive facial treatment for improved tone and volume.  The ePrime treatment creates fractionated zones of thermal injury specific to the reticular dermis without treatment impact to the epidermis, using a patented micro‐needle electrode array to precisely deliver its bipolar RF energy.ePrime ’s patented Intelligent Feedback System (IFS) continuously monitors dermal temperature as set by the practitioner.  Impedance is measured and the RF energy adjusted to achieve targeted temperatures.  Unlike other treatment approaches, ePrime  eliminates treatment variability and delivers predictable and consistent results in a single treatment.  ePrime delivers its tone and volumetric improvements of the skin typically with minimal clinical downtime and minimal risk of side effects, regardless of skin type.  Scientific studies have shown the ePrime treatment to uniquely promote the natural production of new collagen, new elastin and new hyaluronic acid. ePis the first technology  to demonstrate neo-elastogenesis following RF treatment of human skin.  With ePrime’s unmatched precision and real‐time temperature control, physicians can achieve more predictable clinical results for their patients seeking to reverse the signs of aging.

"The main risk of an energy based device which treats a patient's skin is burning, dyschromia and scarring.  The ePrime RF device is an extremely safe device which employs feedback control temperature so the risk of overheating a patients tissue is practically zero.  An additional safety feature is the ability of the operator to visualize correct needle deployment prior to energy activation.  In my experience with over 30,000 cartridge deployments (300,000 needles) on over 30 patients I have not encountered a burn or overtreatment of a patient's skin.  No dyschromia or scarring has been seen.  In comparison to light based energy systems, the ePrime is a significantly safer device for the operator and patient. Furthermore there are no ophthalmology risks for staff or patients."James Newman, MD, FACS

ePrime Safety Proven in Clinical Studies

In a recent study, 15 patients were treated with no adverse events or complications reported:
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.

In another study, 44 patients were treated with no adverse events or complications reported:
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.

In our sixth study pending publication in which 100 patients were treated by 11 treating physicians at 7 sites involving over 16,000 treatment applications, with over 80,000 thermal lesions created, and over 160,000 needle insertions in facial skin, there have been no adverse events or complications.

ePrime Safety FAQs

 
Q:  What is the downtime for patients after an ePrime treatment?

A:  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 can return to usual activities as soon as 24-48 hours, although individual healing times vary from patient to patient.  Typically, any minor redness, swelling or focal bruising as a result of the ePrime  treatment can be covered with makeup within 24-48  hours, although again, individual healing times vary from patient to patient..

Q:  Are the any side effects?

A: 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.

Q: What about bleeding?

A:  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.

Q. What about bruising?

A:  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.

Q: What about swelling?

A:  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 generate new dermal tissue, is taking place.  .  Patients can continue with their lifestyle regardless.

Q: What about burning/blistering?

A:  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