Fotona’nın jinekolojik lazerlerle ilgili açıklaması
FotonaSmooth® and the FDA Safety Communication regarding “feminine rejuvenation” to other companies
Fotona is a pioneer in minimally invasive procedures in gynecology with its patented FotonaSmooth® Er:YAG laser technology enabling non-ablative thermal resurfacing treatments of vaginal tissues. The goal of the FotonaSmooth® laser thermotherapy is to produce vaginal collagen hyperthermia followed by collagen remodeling and new collagen synthesis, resulting in overall regeneration of aged or stressed vaginal tissues. It is important to stress that the Fotona procedure is non-ablative and therefore minimally invasive to the vaginal wall.
Fotona has demonstrated safety and efficacy. During the past decade, Fotona has initiated a very large number of clinical studies in order to test and confirm the safety and efficacy of the FotonaSmooth® thermotherapy. These studies have already resulted in over 4o scientific papers published in some of the most respected international scientific journals confirming the safety and efficacy of FotonaSmooth® procedures. The quality and results of the published studies were such that they enabled Fotona to obtain permission to market and promote its laser systems in the European Union (EU) for the following indications: stress urinary incontinence (IncontiLase®), vaginal laxity – vaginal relaxation syndrome (IntimaLase®), genitourinary syndrome of menopause (RenovaLase®) and pelvic organ prolapse (ProlapLase®). Fotona has also started its activities to obtain the clearance by the US FDA, however since this process was started later than in the EU, it has not been completed yet. Until then, Fotona has not marketed it’s its CE approved gynecological treatments in the US.
In the meantime, the published excellent results obtained with FotonaSmooth® have attracted significant attention of the medical device industry. Very quickly, a large number of very different technologies have been introduced claiming to produce results similar to FotonaSmooth®, in most cases without any significant clinical evidence to back such claims. Many of these technologies have been aggressively promoted also in the US in spite of not having been cleared by the FDA. This practice finally resulted in the recent FDA’s warning to seven Fotona’s competitors for inappropriate marketing of their devices for “vaginal rejuvenation”.
We understand the FDA’s Safety Communication as a warning to medical device manufacturers not to promote their devices for gynecological procedures in the U.S. prior to obtaining an appropriate clearance. Fotona has been fully compliant with this FDA’s requirement, and does not, and has not marketed the subject procedures in the U.S.. However, we are confident that clinical data obtained with FotonaSmooth® will provide sufficient support and evidence for the US FDA to issue a clearance to Fotona’s devices for non-ablative vaginal laser resurfacing procedures.
We would also like to point out that in our opinion the patented FotonaSmooth® technology holds a very unique position within the group of competing technologies. As opposed to competing laser technologies, the FotonaSmooth® dual tissue regeneration is completely non-ablative, and involves not only the additional superficial heat-shocking mechanism of tissue regeneration, but also includes a unique self-regulating safety feature, not available with other technologies. We believe these dual tissue regeneration characteristics of the FotonaSmooth® Er:YAG laser to be responsible for the reported extraordinary safety and efficacy of FotonaSmooth® Er:YAG lasers when used for thermotherapy of the vaginal wall to alleviate symptoms of stress urinary incontinence and genitourinary syndromes of menopause. We also believe FotonaSmooth® to be a much safer alternative to already cleared and widely used procedures involving intravaginal and intra-urethral RF devices or various slings and meshes.