Lutronic's Action II Petit Lady™ Receives CE Mark Clearance for the Treatment of Vaginal Relaxation Syndrome & Stress Urinary Incontinence
Lutronic, a global leader of lasers and therapeutic devices for aesthetic and medical applications, announced today that Action II Petit Lady™ has received CE mark clearance for treatment of vaginal relaxation syndrome (VRS) and stress urinary incontinence (SUI). VRS is a quite common medical condition described as a loss of the optimal vaginal structure and is usually associated with vaginal child delivery and natural aging. SUI refers to the involuntary loss of control of the bladder and it can occur following some normal activity, such as coughing, sneezing, running, heavy lifting or even just bending over.
Current VRS Treatments include surgical procedures and pharmacological therapies; the surgical options available require long recovery and like pharmacological options may cause unwanted side effects. Clinicians have been looking for a better minimally or non invasive solution that provides short downtimes and low risk of side effects.
Non-surgical and non-invasive treatment for vaginal rejuvenation
"Petit Lady is particularly recommended to menopausal patients, because the mechanism of laser remodeling not only rejuvenates the condition of the vagina but also enhances sexual gratification and better quality of life."
Lutronic worked with experienced clinicians to develop a new treatment that meets their patients’ needs. The Action II Petit Lady is a non-surgical, non-invasive and easy to perform laser treatment that enables gynecologists to effectively treat a wide range of vulva-vaginal symptoms and conditions and helps patients solve their most private problems.
“The Petit Lady approach is suggested for females who have vaginal relaxation syndrome but for whom a surgical procedure might not be appropriate because the symptoms are mild and the patient’s concern about pain and downtime. This laser procedure is suitable to be all pied in combination with vaginal muscle reconstruction to obtain a synergetic effect and to achieve better maintenance,” stated Hyung Keun Lee, MD, PhD., Chief director of RIZ Laser Cosmetic Vaginal Surgery Center which is the first clinic specializing in vaginoplasty in Asia. “Petit Lady is particularly recommended to menopausal patients, because the mechanism of laser remodeling not only rejuvenates the condition of the vagina but also enhances sexual gratification and better quality of life.”
This new CE approval enables the Action II Er:YAG laser system to expand its clinical applications and to build on the success of the original Action II device which primarily focused on aesthetic treatments; gaining CE approval for the treatment of scar revision, epidermal benign disorders and epidermal pigment lesions in December 2012.
“Action II Petit Lady is a device that provides a new dimension in Er:YAG laser technology applied to gynecological indications. It has 3 independent operating modes such as the multiple micropulsed mode, the long-pulsed mode up to 1000 ms and a unique Dual mode which allows a deeper secondary thermal effect and controlled heating of the delicate target tissues of the vaginal wall. These improved features also allow for swift wound healing and an excellent tissue tightening effect. The unique patent pending design of the intravaginal scopes provides a more efficient and comfortable procedure.” Stated Mr. S.H. Ko, Lutronic’s international sales director. "The market opportunity for Action II Petit Lady procedure in Europe is substantial and we're looking forward to expanding our presence in Europe,” he added.
Lutronic will initiate the commercial launch of Action II Petit Lady into the EU market through prestige retailers during the third quarter of 2014.
About Action II Petit Lady
The Lutronic Action II Petit Lady is a 360° solution for cosmetic gynecology. The treatment is gentle, simple and fast. The Action II Petit Lady 360° handpiece is specially designed for VRS. It delivers multiple micropulses to the vaginal mucosa to stimulate collagen remodelling and tighten the vaginal canal. The Action II Petit Lady 90º handpiece is intended for SUI, providing an enhanced thermal and shrinkage effect in the endopelvic fascia, ligaments, and mucosal tissue of the anterior vaginal canal.
The robust Action II Petit Lady has a long list of features that support both physician and patient needs.
● Non-invasive, non-surgical procedure
● No downtime and little to no risk of bleeding, pain, or scarring
● Multiple hand-pieces: Petit 360º handpiece, Petit 90º handpiece, & fractional handpiece
● Easy to manipulate articulated arm
● Dedicated GUI for Petit Lady mode
● Multiple modes & 2940 nm Er:YAG laser energy deliver
Previously released outside of the Europe, the Action II Petit Lady is clinically proven in Asia and the Middle East, and has enabled investigators and clinicians to perform many procedures. Action II Petit lady is clinical proven to be efficacious and safe in treating Asian patients; One of the studies, presented at the 34th ASLMS Annual Conference, showed that the unique delivery of the Action II’s Petit 2,940 nm Er:YAG laser energy provided a statistically significant improvement in vaginal relaxation without pain, safety issues, or side effects.
Lutronic, a leading innovator in advanced aesthetic and medical laser and related technology, was established over 15 years ago to bring intuitive, robust, versatile devices that are affordable and efficacious to the worldwide medical community. Committed to improving medicine, Lutronic partners with key opinion leaders to advance science and ensure the efficacy of its systems. All systems are versatile and offer multiple setting and treatment options for customized treatments, which optimize outcomes for a wide variety of conditions and treatments including melasma, tattoo removal, soft tissue incision, vascular lesions, hair removal, wrinkle reduction, skin resurfacing, body/facial contouring, chronic pain and more.
With a focus on physician needs and patient outcomes, Lutronic dedicates time and funding toward the development of devices that offer features and improvements not found in today’s market. Devoting more than 20% of revenues to R&D, Lutronic holds more than 130 current and pending patents worldwide. With more than 230 employees worldwide, Lutronic has offices in the US, Korea, China, Japan, and Europe, a worldwide network of distributors, and is ever expanding.
To learn more about Lutronic Corp, please visit: http://www.lutronic.com/
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