Monday, April 29, 2024
GC Aesthetics® (GCA®), the leading designer, manufacturer and distributor of breast implants and medical devices for the global aesthetics industry provides an industry-leading, micro-textured anatomical breast implant LUNA XT™: the first breast implant in the world approved under the new European Medical Device Regulation (MDR).
Under the new MDR rules, medical standards are updated rigorously to improve product safety ensuring greater openness, traceability and clinical safety evidence. GC Aesthetics® takes pride in being the first breast implant manufacturer globally to introduce a new product under the newly approved MDR rules in their commitment to women’s healthcare and safety.
According to the NHS website, 2,100 breast reconstruction surgeries took place in 2022 with a further 460 carried out through independent/private clinics. This procedure in the UK has increased by 36% since 2017 which highlights the demand for products, devices and implants that have been approved under the new MDR.
The new Luna XT™ Anatomical Breast Implant provides industry-leading support for women undergoing immediate and delayed breast reconstruction surgery. Its unique, microtextured surface, highly cohesive silicone gel and high-performance shell are a state-of-the-art option for women who wish to undergo breast procedures, with a reliable and safe device based on 40 years of expertise in the market. Luna XT™ is available in a variety of projections, heights and volumes which makes it an all-rounder to suit different patients and their needs.
Carlos Reis Pinto, CEO at GC Aesthetics®, said:
“Being the first to launch the first MDR-approved breast implant in the market is a testimonial of GC Aesthetics' commitment to women's healthcare and safety. MDR rules have been designed to improve product safety ensuring greater openness, traceability, and clinical safety evidence. Having the first breast implant manufacturing system in the world certified under the new MDR rules demonstrates that our company continues to pursue excellence and customer satisfaction”
Fara Naomi Macías, CMO of GCA, said:
“It is GC Aesthetics’ commitment to offer a strong and comprehensive portfolio of products for women. We are committed to delivering safe options that establish a newer, higher, and more beneficial standard of care for women who seek to recover their breast and nipple shape, look, and feel”
About GC Aesthetics:
GC Aesthetics® (GCA®), is the global designer, manufacturer and distributor of breast implants and medical devices for aesthetic and reconstructive procedures. GC Aesthetics® (GCA®) proudly stands as the leader in the innovation and advancement of medical devices for over 40 years.
Operating in over 70 markets worldwide, GCA® proudly boasts a track record of proven safety with products supported by extensive 10-year clinical safety data and up to 17-year patient satisfaction data. GCA’s dedication to quality is underscored by the fact that every product, from inception to production, is meticulously crafted and designed in Europe.
GCA® takes pride in being the first breast implant manufacturer globally to introduce a new product under the newly approved Medical Device Regulation (MDR). Luna XT™ is an anatomical breast Implant providing industry-leading support for women undergoing immediate and delayed breast reconstruction surgery. This achievement emphasises the company's dedication to staying at the forefront of industry standards and regulations.
Holly Scott
Digital PR Manager
Email: holly@distinctlypr.co
Telephone: 01923 728191
