(Redwood City, CA – July 22, 2016) Recently cleared by the FDA for use in the U.S., the New INTRAcel from Jeisys Medical, Inc. (Seoul, South Korea), is a revolutionary skin rejuvenation system that appears to be a panacea for a wide-range of aesthetic concerns. Achieving outcomes that surpass other medical aesthetic devices, the INTRAcel has become an important player internationally in this highly competitive aesthetic market.
Although Perigee Medical is introducing INTRAcel in the U.S. today after recent clearance by the FDA, microneedle treatment has been in practice globally for more than a decade, according to Michael H. Gold, M.D., director of Gold Skin Care Center and Tennessee Clinical Research Center (Nashville, Tennessee, U.S.). “We’ve seen worldwide use of the rolling microneedle therapies for some time, and outside the U.S. there are a few competitors to INTRAcel. Jeisys is a leader in the field of microneedle technology. As a technological approach to RF delivery, microneedling is a great way to enhance skin volume through neocollagenesis, and treat scars and wrinkles aggressively with minimal downtime and high satisfaction.”
Using patented controlled Fractionated Radiofrequency Microneedle™ (FRM) technology, INTRAcel’s insulated microneedles quickly penetrate the target area without thermally damaging the epidermis. Once the microneedles enter the skin, a pulse of radiofrequency (RF) energy is emitted into the target tissue at preselected precise depths within the skin. Fractional thermolysis, applied at variable energies and different depths, can be very effective in the treatment of acne, acne scars, wrinkles, fine lines and large pores, as well as a minimally-invasive face-lifting effect.
RF microneedle technology was invented by Jeisys, and INTRAcel is the first RF microneedle system to be introduced and is the only system protected by a U.S. patent which covers insulated microneedle technology. The patent ensure users of INTRAcel in the U.S. will have a continual supply of microneedle components.
The New INTRAcel is the only system equipped with four distinctive functions: invasive bi-polar RF microneedle modality, a monopolar RF modality, as well as non-invasive SRR (Superficial RF Rejuvenation) treatments for sublative therapy, and non-RF modality. These modalities can be used alone or combined in a unique, Three or Four Layer Therapy (TLT) approach. While bi-polar RF causes a coagulative necrosis zone at a precise depth the dermis, monopolar RF creates a wider denaturation zone. The SRR mode is then used far soft peeling of the epidermis, completing the TLT approach. The non-RF T-mode can be used in conjunction with topical treatments.
The New INTRAcel is the only insulated microneedle system to offer mono-polar RF. This instantly creates a broader more effective heated zone for certain applications avoiding the painful long pulses required from other microneedle systems that rely on long pulse times to spread heat into wider zones. Other, similar devices use non-insulated needles, large angled needles or insulated needles with o single bipolor system. INTRAcel has insulated needles that emit both monopolor and bi-polar RF energy from a single system.
“For scarring and photo-aging, such as superficial wrinkling and skin laxity, one can use the monopolar and bipolar frequencies alone; however, you get an enhanced tightening and firming when combining both of these modalities,” said Nick Lowe, M.D., consultant dermatologist (London, England), and professor of dermatology at UCLA (Los Angeles, Colifornia, U.S.).
“I believe that INTRAcel is probably the safest of the RF needle-driven systems,” Dr. Lowe advised. “You have good control over depth and importantly you have insulated needles with monopolar and bi-po· lar functions. Compared to other devices on the market, INTRAcel stands alone.”
The New INTRAcel has also added on impedance checking function that helps return energy back to the target area and maximize the energy output value. The impedance checking function automatically calculates the output value and applies it to each shot. This function has solved the current difficulty of RF machines, further increasing INTRAcel’s safety and efficacy.
In Dr. Gold’s opinion, the impedance monitoring function is essential when using the FRM monopolar mode. “The feedback mechanism automatically calculates the output value and applies it to each shot. The difference in delivery between monopolar RF and bi-polar RF make this necessary to maximize safe and effective intradermal monopolar RF delivery,” he advised. “No single treatment is going to apply to all patients,” Dr. Gold continued, “so in the foreseeable future a versatile platform device like the All New INTRAcel is going to have a significant impact on what we do in aesthetic medicine.” He added “As safe as these devices are, any device of this kind requires proper training and knowledgeable, cautious use by skilled professionals.”
“Needing only topical anesthesia, with no oozing and very little, if any bleeding, no hematoma or major edema after the procedure, and the 49 needle tip, the entire office visit is very brief compared to many other therapies,” said Klaus Fritz, M.D., director of the Dermatology and Laser Centers (Landau, Germany) and lecturer at Universität Bern (Switzerland) and Universität Osnabrück (Germany). “This makes FRM with INTRAcel a true lunchtime procedure, a distinct advantage when dealing with busy professionals, which aesthetic practitioners often do.”
Dr. Fritz explained that with INTRAcel, RF energy creates controlled heat injury at each treatment site, denaturing collagen without noticeable damage to the epidermis. “The needles are even smaller in diameter than the 32 gauge needle used for neurotoxin injection, so the impact to the epidermis is negligible at most,” he said. “Although the U.S. Food & Drug Administration (FDA) would technically refer to this as an invasive procedure, it is largely non-invasive because barrier function is virtually preserved. Fractional ablative lasers, for example, must damage the skin and it takes a few days for barrier repair to take place, depending on the size of the ablation area.”
While the INTRAcel device was originally developed to treat acne scars, it may also be successfully used for skin tightening in rejuvenation treatments and for striae on the body, stated dermatologist Marge Uibu, M.D., chief physician at Ihoakatemia (Helsinki, Finland). “I believe INTRAcel represents a new standard for rejuvenation and acne scarring for all skin types, with little downtime,” she said. “One great advantage with INTRAcel is that the result is very natural looking. You see great improvement but the skin does not look treated. I have used INTRAcel to treat the full face, neck and décolleté in one session because of the adjustable needle depth and energy level. I have also
Perigee Medical offers products from worldwide leaders and pioneers in the laser and medical device industry. Products include laser sources, RF technology, ultrasound and innovative laser systems and energy sources for a wide range of medical applications. Perigee Medical management team has focused on aesthetic and surgical devices since 1990.