CO2RE Intima

Vajinal Rejuvenation

candelamedical.com

• CO2RE is a slimly profiled, compact laser, which has an RF-excited Coherent GEM 30A laser tube optically coupled to a 2-axis scanner and a beam relay incorporated into an articulated arm that allows for easy manipulation of the delivery end relative to the treated tissue region.
• For treatment of both the vaginal canal and external regions, the Deep Mode is used for deeper tissue remodeling:  consists of 3 to 64 micro-beams each of which has a diameter of 150 micrometers (microns).  Each of the micro-beams can be set to deliver 30-70mJ of energy, which correlates to fluences of 170-396.  The exact ablation and coagulation depth depends upon the local water content in the tissue being treated.  Typical values for mucosal tissue penetration, in the treatment fluence range administered by a single pulse, are from 500-700 micrometers.
• There is an in-board scanner inside the device so that the handpieces are light, easily maneuverable and not obstructed by a bulky scanner.  This may be an advantage of the CO2RE over other Fractional CO2 devices (Mona Lisa Touch).

Women seeking overall functional & cosmetic improvement in their vaginal area:

• • to Relieve the signs of Childbirth and Aging
  • to Restore and return to their pre-menopausal and pre- childbirth vaginal health
  • to Enhance sexual functioning for a better sexual experience, and
  • To gain more Confidence about their feminine well- being

Women’s Vaginal Health Conditions:

Changes in genitourinary anatomy and physiology can adversely affect female sexual health and quality of life over a woman’s lifetime.

1. Vulvovaginal Atrophy (VVA)

Thinning, drying and inflammation from loss of estrogen

Associated with Stress Urinary Incontinence (SUI)

2. Vaginal Relaxation Syndrome (VRS)

Vaginal looseness – both introitus and canal – typically resulting from childbirth

3. Aged Vaginal Appearance

Pigmentation, dystrophy, vulvar laxity

CO₂RE Multi-Application Platform

• Proven Precision Focused Platform
• RF-excited CO₂ controlled delivery for uniform treatment with no pulse to pulse variation
• Wavelength of choice for ablation and coagulation
• CO₂ lasers have been shown to remodel tissue with formation of new collagen and elastin fibers in atrophic skin*

Clinical Overview

• CO₂ lasers have been shown to remodel tissue with formation of new collagen and elastin fibers in atrophic skin*
• CO₂ thermal properties stimulate healing responses that enhance moisture levels in the vaginal canal and restore flexibility, tone and shape
• CO₂RE Intima treats the internal vagina, external vulva and introitus areas, with superior hygiene of single-use disposable handpieces

Mechanism of Action of CO2 – Scientifically Proven, Validated

• CO2 lasers reach all various temp thresholds necessary for optimal ablation and coagulation of tissue, and both mechanisms are impt in rejuvenation and tissue remodeling (= collagen remodeling or contraction AND new collagen formation = big adv over RF and Erbium)

Ablation occurs when water is instantly heated >100 degC and vaporization of tissue occurs.  This effect improves epidermal texture and pigmentation, and zones of coagulation beyond the ablation zones are produced, where temps that induce partial collagen denaturation (65-67degC) and subsequent remodeling occur

Ablation is necessary to treat dyschromia. . Neocollagenesis (>RF) occurs and is long-lasting.  Making the CO2 fractional ensures that there is low risk and rapid healing, by preserving surrounding normal zones of tissue around the energy-affected thermal zones…in vaginal tissues, there is no downtime, and no appreciated edema or exudate (fractional energy does not elicit a surface tissue response similar to a burn)

Vaginal histology reveals increased vascularity/fibroblasts/new collagen/and dermal remodeling which improves elasticity (VRS), and tissue structure around the anterior vaginal wall under the mid-portion of the urethra (SUI)

For patients with VVA, the vaginal epithelium thins due to loss of estrogen.  CO2 laser treatments restore elasticity and better lubrication by returning the tissues to a more acidic normal pH through liberation of glycogen and acidic mucins of the epithelium, thus alleviating dryness, itching, dysuria, and recurrent infection through a rebalancing of the lactobacilli content that keeps pathogenic bacteria and yeast at bay.  The vaginal tissue becomes better vascularized, and natural lubrication and hydration is restored.

CO2RE can treat multiple levels of tissue simultaneously to treat dyschromia and to remodel tissue, and can ablate, coagulate and stimulate tissues by its heat, so it is a comprehensive vaginal treatment.  The operator can move from the surgical mode, that can be used to incise/excise lesions, to a fully ablative or fractional mode.

Unparallelled ability to treat both superficial and deep skin layers simultaneously with precision control over the intensity, pattern and depth of ablation without changing handpieces.

Loesch MM, Goldman MP, Fitzpatrick RE, Miles CA, Bernstein E (1996 – 2014).

Prior Studies of CO2 Effects on Vaginal Tissue

• Gaspar A, et al, 2011:  Fractional CO2 improved vaginal tissue in all layers, bx showed improvement in all 3 layers of tissue versus only the epithelium with estrogen
• Salvatore, et al, 2015:  Bx proven remodeling of vaginal connective tissue by demonstrating increased content of collagen, elastin and fibroblasts
• Zerbinati, et al, 2015:  Demonstrated new collagen and extracellular matrix in vaginal mucosa after a single treatment with fractional CO2 at 30 and 60 days post-Rx
• Salvatore, Perino, et al, 2015:  Reported improved symptomatology and high patient satisfaction with fractional CO2 laser for vaginal dryness, burning, itching, dyspareunia, sexual function and quality of life, utilizing Vaginal Health Index Scale, Vaginal Atrophy Scale and a 5-point Likert Scale…over 100 patients, over 90% satisfaction rate