Sam Brusco, Associate Editor10.04.22
GC Aesthetics (GCA), a medtech company that provides aesthetic and reconstructive solutions for women’s healthcare, has earned CE mark approval for its new LUNA xt micro-textured anatomical breast implant.
The new product is a response to surgeon and patient needs in breast reconstructive procedures. The microtextured surface, cohesive silicone gel, and high-performance shell helps make the device reliable and safe for women wishing to undergo breast procedures, according to the company.
LUNA xt is the first breast implant approved under the new European Medical Device Regulation (MDR).
“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,” Carlos Reis Pinto, CEO of GC Aesthetics told the press.
LUNA xt completes GC Aesthetics’ full breast reconstruction offer—the company launched FixNip a few months ago to reconstruct the nipple-areola complex with long-lasting nipple projection.
“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,” said Fara Naomi Macias, chief marketing officer for GCA.
The new product is a response to surgeon and patient needs in breast reconstructive procedures. The microtextured surface, cohesive silicone gel, and high-performance shell helps make the device reliable and safe for women wishing to undergo breast procedures, according to the company.
LUNA xt is the first breast implant approved under the new European Medical Device Regulation (MDR).
“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,” Carlos Reis Pinto, CEO of GC Aesthetics told the press.
LUNA xt completes GC Aesthetics’ full breast reconstruction offer—the company launched FixNip a few months ago to reconstruct the nipple-areola complex with long-lasting nipple projection.
“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,” said Fara Naomi Macias, chief marketing officer for GCA.