GC Aesthetics Gains MDR-Approval for Luna XT

GC Aesthetics, a manufacturer and distributor of breast implants and medical devices for the global aesthetics industry announced the micro-textured anatomical breast implant Luna XT as the first breast implant in the world approved under the new European Medical Device Regulation (MDR).
 
“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,” said GC Aesthetics CEO, Carlos Reis Pinto. “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”
 
The Luna XT Anatomical Breast Implant offers support for women undergoing immediate and delayed breast reconstruction. It is 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, making it an all-rounder to suit different patients and their needs.
 
The implant has a microtextured surface, highly cohesive silicone gel, and a high-performance shell that is a state-of-the-art option for women who wish to undergo breast procedures.
 
Company CMO, Fara Naomi Macías, 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”
 
Under the new MDR rules, medical standards are updated to improve product safety ensuring greater openness, traceability, and clinical safety evidence.