New CE Mark Sees World’s First Externally Scannable RFID Breast implants

Breast implant manufacturer Establishment Labs, S.A. (EL) and VeriTeQ Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, are partners in the provision of breast implants that contain RFID chip technology. EL’s new range has now been CE Marked, meaning patients can be simply scanned for retrieval of information in the event of recall or other product query.

Background

EL has received CE Mark approvals for its Motiva Implant Matrix® VelvetSurface PLUS with Q Inside Safety Technology and Motiva Implant Matrix® SilkSurface PLUS with Q Inside Safety Technology. With this news, EL’s Motiva Implant Matrix product line with VeriTeQ’s Q Inside Safety Technology has become the world’s first externally identifiable breast implant.

VeriTeQ’s FDA cleared Q Inside Safety Technology acts as an electronic serial number in breast implants and other implantable and reusable medical devices. By including VeriTeQ’s Q Inside Safety Technology in Motiva Implant Matrix® implants, manufacturers, physicians and patients will have access to a secure online database to retrieve implant-specific data such as serial number, manufacturer name, date of manufacture, lot number, volume, size, and other data from the medical device manufacturer. Q Inside Safety Technology also provides an extra level of protection to the patient in the event of a recall or other safety event.

About its Motiva SilkSurface PLUS implants, EL says they provide a soft, gliding printed nano-surface that reduces complications related to traditional textures while reducing capsular contracture rates. Motiva’s VelvetSurface PLUS implants provide a printed micro-surface that promotes a more secure fit in the breast pocket.

Company comments

for Establishment Labs

“We continue to advance the safety and exclusivity of our entire breast implant portfolio to answer the demands from both physicians and patients alike,” said Juan José Chacón-Quirós, CEO of Establishment Labs. “Including VeriTeQ’s Q Inside Safety Technology in Motiva’s SilkSurface PLUS and VelvetSurface PLUS implants emphasizes our primary focus of providing best-in-class products for the protection of the patient.”

for VeriTeQ 

Scott R. Silverman, Chairman and CEO of VeriTeQ, stated, “We believe these new CE Mark approvals will provide continued momentum for EL’s product launch in the EU. Giving physicians and patients the power to identify their breast implants in a healthcare setting is the next generation of technology and security, and we believe both groups will ultimately demand this level of safety from their implants.”

Source: VeriTeQ Corporation, Business Wire

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