GC Aesthetics Obtains CE Mark for the New LUNA xt™ Anatomical Breast Implant, the First Under MDR

October 3, 2022 |

2 min read

GC Aesthetics® (GCA®) a privately-held medical technology company providing aesthetic and reconstructive solutions for women’s global healthcare markets is proud to announce the CE approval of the new micro-textured anatomical breast implant LUNA xt™, the first breast implant in the world approved under the new European Medical Device Regulation (MDR).

DUBLIN--(BUSINESS WIRE)-- GC Aesthetics® (GCA®) a privately-held medical technology company providing aesthetic and reconstructive solutions for women’s global healthcare markets is proud to announce the CE approval of the new micro-textured anatomical breast implant LUNA xt™, the first breast implant in the world approved under the new European Medical Device Regulation (MDR).

The new LUNA xt™ Anatomical Breast Implant is GC Aesthetics’ latest innovation, which provides an industry-leading response to both surgeon and patient needs in breast reconstruction procedures. It’s unique and proven safe microtextured surface, highly cohesive silicone gel and high-performance shell, is the 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.

“I am proud to launch the first MDR approved breast implant in the market. This is a great accomplishment and a recognition for the work accomplished by our teams. Being the first one is another testimonial of GC Aesthetics commitment to women 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” said Carlos Reis Pinto, Chief Executive Officer of GC Aesthetics.

With LUNA xt™, GC Aesthetics is completing its full offer for breast reconstruction. The launch of FixNip™, a few months ago, a one-of-a-kind implant for the reconstruction of the nipple-areola complex with long-lasting nipple projection, positions GC Aesthetics® with a unique value proposition in Breast Reconstruction, supporting the best outcome for women undergoing immediate and delayed breast reconstruction surgery.

“It is GC Aesthetics’ commitment to offer a strong and comprehensive portfolio of products for women. We are committed to deliver 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” mentioned Fara Naomi Macias, Chief Marketing Officer for GCA.

About GC Aesthetics

GC Aesthetics is a long-established global medical technology company that develops, manufactures, and markets a comprehensive range of proprietary aesthetic and reconstructive products.

Throughout its 40-year history, GCA has been dedicated to advancing the science of medical aesthetics and delivering high-quality breast implants for breast augmentation and breast reconstructive surgery. We have sold more than 3 million implants across 70 countries, and our products are supported by published 10-year clinical data demonstrating compelling safety and clinical effectiveness.