The US Food and Drug Administration (FDA) has granted 510(k) clearance to RTI Biologics' porcine dermis implant for use in soft tissue repair procedures such as hernia repair.
The implant is comprised of non-crosslinked porcine dermis and will made available in various shapes and sizes.
The ready-to-use implant, which is sterilized through the Tutoplast Tissue Sterilization Process, is designed to act as a scaffold that allows for neovascularization and reincorporation with the patient's own tissue.
It will be processed at the company's facility in Neunkirchen, Germany for commercial distribution in the US later in 2013.
RTI Biologics president and chief executive officer Brian Hutchison said, "Our newly developed surgical specialties direct distribution team is eager to add the porcine dermis implant to their current biologics portfolio, and this clearance supports our schedule for a full launch later this year."
