DUBLIN–(BUSINESS WIRE)–GC Aesthetics® (GCA®) a privately-held medical expertise firm offering aesthetic and reconstructive options for girls’s world healthcare markets is proud to announce the CE approval of the brand new micro-textured anatomical breast implant LUNA xt™, the primary breast implant on this planet permitted underneath the brand new European Medical System Regulation (MDR).
The brand new LUNA xt™ Anatomical Breast Implant is GC Aesthetics’ newest innovation, which offers an industry-leading response to each surgeon and affected person wants in breast reconstruction procedures. It’s distinctive and confirmed secure microtextured floor, extremely cohesive silicone gel and high-performance shell, is the state-of-the-art choice for girls who want to bear breast procedures, with a dependable and secure system based mostly on 40 years of experience available in the market.
“I’m proud to launch the primary MDR permitted breast implant available in the market. This can be a nice accomplishment and a recognition for the work completed by our groups. Being the primary one is one other testimonial of GC Aesthetics dedication to ladies healthcare and security. MDR guidelines have been designed to enhance product security making certain better openness, traceability, and medical security proof. Having the primary breast implant manufacturing system on this planet licensed underneath the brand new MDR guidelines demonstrates that our firm continues to pursue excellence and buyer satisfaction” mentioned Carlos Reis Pinto, Chief Government Officer of GC Aesthetics.
With LUNA xt™, GC Aesthetics is finishing its full supply for breast reconstruction. The launch of FixNip™, just a few months in the past, a one-of-a-kind implant for the reconstruction of the nipple-areola advanced with long-lasting nipple projection, positions GC Aesthetics® with a singular worth proposition in Breast Reconstruction, supporting the perfect final result for girls present process fast and delayed breast reconstruction surgical procedure.
“It’s GC Aesthetics’ dedication to supply a robust and complete portfolio of merchandise for girls. We’re dedicated to ship secure choices that set up a more moderen, increased, and extra useful commonplace of care for girls who search to get better their breast and nipple form, look, and really feel” talked about Fara Naomi Macias, Chief Advertising Officer for GCA.
About GC Aesthetics
GC Aesthetics is a long-established world medical expertise firm that develops, manufactures, and markets a complete vary of proprietary aesthetic and reconstructive merchandise.
All through its 40-year historical past, GCA has been devoted to advancing the science of medical aesthetics and delivering high-quality breast implants for breast augmentation and breast reconstructive surgical procedure. We’ve offered greater than 3 million implants throughout 70 international locations, and our merchandise are supported by printed 10-year medical knowledge demonstrating compelling security and medical effectiveness.
