BioCer Announces CE Approval for Mastectomy "Bra"
BioCer Announces CE Approval for Mastectomy "Bra" plus FDA Approval for Hernia repair system TiO2Mesh(TM)
BAYREUTH, Germany, November 7, 2013 /PRNewswire/ --
BioCer Entwicklungs GmbH (BCE), a German based medical device manufacturer, announces new CE mark indication for TiO2mesh(TM) Bra and also TiO2Mesh(TM) hernia repair system has now been FDA approved for sale in the USA. TiO2Mesh(TM) Bra is a unique titanium coated support biocompatible solution for use in reconstructive Mastectomy surgeries, and is now approved for sale in the EU. Immediate reconstruction procedures, in which breast reconstruction begins at the same time as the mastectomy, are now the "gold standard" for breast cancer patients where supportive mesh to aid support of implants is a requirement.
Utilizing the same technology platform as that used with recently FDA approved Hernia repair system TiO2Mesh(TM) a surgical mesh implant for repair of soft tissue defects of the abdominal wall, TiO2Mesh(TM) Bra is a new indication approved for use in Europe in reconstructive breast surgery. TiO2Mesh(TM) is made from a monofilament polypropylene thread and has a large-pore structure with blue orientation stripes. TiO2Mesh(TM) is surrounded by a high-purity and adherent titanium dioxide surface coating to enhance biocompatibility. The lightweight character and the large-pore size reduce material surface thereby minimizing foreign body reactions. This is confirmed by studies comparing
TiO2Mesh(TM) with uncoated materials and demonstrates a significant increase in cell viability and cell growth due to the biocompatible coating. TiO2Mesh(TM) features incorporate and address the unmet requirements of combining strength with flexibility, biocompatibility, and increased surgical site visualization. The Hydrophillic nature of the coating benefits in a reduced need for fixation in certain procedures. In addition to the standard sizes and shapes, bespoke implant sizes for specific indications are also available upon request.
Dr. Markus Heinlein, Managing Director of BCE, commented, "The 510(k) clearance of
TiO2Mesh(TM) will allow US hernia patients and surgeons to share in the benefits currently utilized in Europe. 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."
BioCer Entwicklungs-GmbH, manufactures TiO2Mesh(TM), Bra and recently launched
HaemoCer(TM) Plus an advanced rapid action surgical hemostat for the control of blood-loss in surgical procedures. BCE manufacture all products in Germany. BCE are exhibiting at Medica and at the Asia Pacific Hernia Society, November 27th-28th, Hong Kong. For information, distribution inquiries, and licensing options, please visit http://www.biocer-gmbh.de or email firstname.lastname@example.org.
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Posted: November 2013