German medical device maker BioCer this week touted regulatory wins in the U.S. and in the U.K. for devices in its TiO2Mesh line, including for its mastectomy bra and hernia repair mesh.
The TiO2Mesh "bra" device is used as support for breast implants for cancer patients undergoing procedures in which reconstruction begins at the same time as the mastectomy, according to a press release. The bra uses the same mesh technology platform used in the TiO2Mesh hernia repair device, which just won clearance from the FDA.
The mesh features a novel titanium coating intended to improve biocompatibility, according to a company statement. It’s designed to be light-weight and has proven in comparative trials to improve cell viability and growth compared to non-coated alternatives.
"The 510(k) clearance of TiO2Mesh will allow US hernia patients and surgeons to share in the benefits currently utilized in Europe," managing director Dr. Markus Heinlein said in prepared remarks. "The new mastectomy approval of Bra in the EU will benefit breast reconstruction patients, and confirms our commitment to innovation."
"BioCer’s portfolio of products will continue to develop strongly in 2014, to meet international demand in our commercial spaces of biocompatible technology in coated mesh systems and plant based hemostasis," he added.