The new European Medical Device Regulation (MDR) has approved a breast implant for the first time, according to a press release from GC Aesthetics® (GCA®).
Under the new MDR rules set forth by the European Union (EU), medical standards are updated rigorously to improve product safety ensuring greater openness, traceability and clinical safety evidence. The EU designated GCA’s micro-textured, anatomical breast implant, LUNA XT™, as MDR-approved.
“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 Carlos Reis Pinto, CEO of GC Aesthetics®. “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 provides support for women undergoing immediate and delayed breast reconstruction surgery. Its 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 to suit different patients and their needs.
“It is GC Aesthetics’ commitment to offer a strong and comprehensive portfolio of products for women,” said Fara Naomi Macías, CMO of GCA. “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.”
