CO2RE Intima*

FAQ

What are women talking about?
Regardless of age, women can experience changes in vaginal wellness or appearance that can affect quality of life in unexpected ways, leading to unpleasant symptoms.
What is CO2RE Intima?
CO2RE Intima is a new, in-office, non-surgical treatment that uses laser energy to treat the symptoms women may be experiencing. CO2RE Intima is a medical laser that delivers controlled CO2 energy to the vaginal or vulva tissue – so cells make more collagen – improving skin tone, texture and appearance.
Has the CO2RE Intima been clinically studied?
Recent results from a hospital-based trial, evaluating vaginal rejuvenation laser treatment on premenopausal women, shows positive results and a high patient satisfaction rating for cosmetic improvement and enhancement in sexual functioning1. A multi-site study is currently ongoing in the USA to evaluate the laser treatment on postmenopausal women, who are experiencing gynecologic wellness issues, and is being conducted by Dr. Martin Garcia, a board-certified Obstetrician/Gynecologist specialist in women’s gynecological health, endocrinology and infertility at Garcia OB/GYN Associates in Florida, Dr. Julene Samuels, a board-certified Plastic Surgeon and Associate Clinical Professor of Plastic Surgery at the University of Louisville in Kentucky and Dr. Lori Warrens, an Obstretrician/Gynecologist and Associate Professor of Gynecology at the University of Louisville in Kentucky.
What are CO2RE’s FDA clearances?
CO2RE is FDA cleared for more than 90 indications for use across an array of medical specialties including aesthetic surgery (dermatology and plastic surgery), and gynecology, among others. In the dermatology and plastic surgery specialties, CO2RE is indicated for, among other applications: “clinical literature demonstrates that skin resurfacing of wrinkles, rhytids and furrows with CO2 laser increases the amount of sub-epidermal collagen.”2 The full list of FDA clearances for CO2RE is available from your Syneron Candela sales representative.
What conditions does CO2RE Intima treat?
In the gynecology specialty, CO2RE performs laser incision, excision, ablation and/or vaporization of soft tissue, for treatment of condylomas, vulvar dystrophies, and benign lesions of external genitalia. It is used for treating the introitus and improving the appearance of the external genitalia, to reduce dyschromia and for remodeling of connective vaginal tissue.
What are the features that make CO2RE a smart investment?
The versatility of the CO2RE laser allows for a comprehensive rejuvenation technique from fractional to full resurfacing and a surgical mode for excision or incision of tissue. CO2RE is a versatile platform, which offers proven solutions for skin resurfacing, wrinkle and scar reduction, pigmentation, minor dermal incisions and excisions, and now vaginal treatments. CO2RE, which employs an RF-excited, digital super pulsed CO2 laser, gives physicians the ability to treat both superficial and deep skin layers simultaneously with precision control over the intensity, pattern and depth of ablation. The CO2RE Intima model expands your treatment options by expanding your practice to the emerging and growing women’s intimate wellness market. CO2 laser treatment has been well studied over many years for its effects on human tissue, and it remains the current gold-standard for tissue rejuvenation. The CO2RE laser is exceptionally versatile and comfortable to use in the treatment of a spectrum of genitourinary pathology involving the skin and soft tissues. The sterile, single-use handpieces assure women of the hygiene they expect of treatments in this intimate area.
Why is an RF-excited, digital super pulsed CO2 better than those which are DC-excited?
The RF-excited digital super pulsed CO2 laser of CO2RE delivers a smooth top hat pulse with better ablationcoagulation ratio for optimal results. DC-excited CO2 lasers deliver pulses with non-ablative emission tails, which can result in less optimum ablation-coagulation ratio and in patient discomfort.
Why are CO2 lasers better for intimate treatments of the vagina compared to Erbium YAG lasers?
As compared to Erbium YAG lasers, which cause tissue contraction as a normal part of the wound healing response, CO2 lasers stimulate collagen via heat induced collagen contraction and subsequent stimulation. There is an increased risk of scarring seen in wound contracture , following Erbium YAG treatment, compared to heat induced collagen formation. 3
What is the mechanism of action (MOA) of CO2 lasers for treating the vaginal canal?
CO2 lasers reach temperature thresholds for coagulation, contraction, denaturization and subsequent stimulation of collagen. Fibroblasts are found during the proliferation phase and subsequent histology reveals collagen remodeling and new deposition. Laxity is improved with generalized tissue rejuvenation over the entirety of the vaginal canal.
What is the mechanism of action (MOA) of CO2 lasers for treating vulvar and vaginal atrophy (VVA)?
A different mechanism is at play in the treatment of VVA, which is characterized by thinning of the epithelial lining of the vagina and lower GU tract. In this case, treatment targets the loss of elasticity and diminished vaginal lubrication.4 Zerbinati, et al.3 observed that CO2 laser was capable of inducing changes in the vaginal epithelium that nourish the vaginal wall and prevent infection-causing bacteria and yeasts from proliferating. Additionally, there is structural improvement in the connective tissue with new active fibroblasts, collagen and ground substance and the presence of typical blood capillaries representing healthy vascularization.4
I have read about other vaginal treatments; why is CO2RE Intima better or different?
CO2RE Intima is a module of the CO2RE device which treats all three areas of a women’s intimate needs (external, internal and introitus) and with sterile, single-use hand pieces, thereby assuring women of the results and hygiene they expect for treatments to their most intimate area. Additionally, CO2RE Intima utilizes a CO2 laser. CO2 lasers have been proven to remodel tissue with neoformation of collagen and elastic fibers in atrophic skin.5 CO2 technology also provides physicians with the ability to treat both superficial and deep skin layers simultaneously and with the precision control they need over the intensity, pattern and depth of ablation, which is very important for treatments to this intimate area.
Is the procedure safe? Are there risks to laser treatment, especially in the vaginal area?
The CO2RE device has FDA clearance for a range of gynecological and genitourinary indications. CO2RE Intima offers solutions for a range of intimate aesthetic procedures. Treatments are safe and effective with mild to no discomfort, and with little downtime.
How many treatments does it take?
Patients receive three in-office treatments that are spaced ~3 weeks apart.
When will patients see results?
Most CO2RE Intima patients feel and see improvement after the very first treatment, although the procedure calls for three treatments.
How long does treatment last?
After the third treatment, patients should expect to come back annually for a maintenance treatment.
Can CO2RE Intima be used for Vaginal Laxity? Vaginal Relaxation Syndrome?
Loss of vaginal sensation and tone can be a side effect of vaginal childbirth and aging. Over time, the vaginal wall and the entrance to the vaginal canal (Introitus), both which contain collagen fibers, can stretch and lose vaginal tissue tone and elasticity. The CO2RE Intima laser treatment results in a remodeling of these tissue fibers, thereby restoring flexibility and shape.
Can CO2RE Intima be used for modifying the appearance of the vaginal area?
The CO2RE Intima laser treatment can remodel labial and vulvar tissue fibers, restoring flexibility and shape. The treatment can also address dyschromia and skin pigmentation resulting in improved skin texture and tone.
For which women is the CO2RE Intima most suitable?
CO2RE Intima is designed for women who want to relieve the signs of childbearing and aging in their vaginal area. This includes post childbearing and peri and menopausal women, women who desire enhancement in sexual functioning and a better sexual experience, women who seek vaginal cosmetic improvement and women who want to feel more confident about their feminine health.
Citations
1 Clinical Study, HM Monteprincipe Hospital, Madrid, Spain, 2015 2 Direct quote from CO2RE FDA clearance. 3 Zerbinati N, Serati M, Origoni M, et al. Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatments. Lasers Med Sci (2015) 30:429-436. 4 MacBride MB, Rhodes DJ, Shuster LT. Vulvovaginal Atrophy. Mayo Clin Proc 2010;85:87-94 5 Salvatore, S, et al. Histological study on the effects of microablative fractional CO2 laser on atropic vaginal tissue: an ex vivo study. Menopause. 2015, Jan 20. (Epub ahead of print).
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