RTI Biologics® Receives 510(k) Clearance for Porcine Dermis Implant
ALACHUA, Fla.--(BUSINESS WIRE)-- RTI Biologics Inc. (RTI) (Nasdaq:RTIX), a leading provider of orthopedic and other biologic implants, is pleased to announce that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its porcine dermis implant. The implant is intended for use in soft tissue repair procedures such as hernia repair.
Stored hydrated and ready-to-use, the porcine dermis implant is comprised of non-crosslinked porcine dermis, designed to act as a scaffold that allows for neovascularization and reincorporation with the patients own tissue. The implants will be made available in various shapes and sizes.
The implant is sterilized through the Tutoplast® Tissue Sterilization Process, which is a chemical process to sterilize and preserve tissue for implantation. Since the first clinical use in 1971, there has been zero incidence of implant-associated infection from millions of implants sterilized through the process.
The implants will be processed at RTIs facility in Neunkirchen, Germany for commercial distribution in the U.S. later this year. The facility has been validated for processing and has begun production of the implants.
We are extremely pleased to have received 510(k) clearance in the first quarter of the year, said Brian K. Hutchison, president and chief executive officer. 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.
About RTI Biologics Inc.
RTI Biologics Inc. is a leading provider of sterile biologic implants for surgeries around the world with a commitment to advancing science, safety and innovation. RTI prepares human donated tissue and xenograft tissue for transplantation through extensive testing and screening, precision shaping and using proprietary, validated processes. These allograft and xenograft implants are used in orthopedic, dental and other specialty surgeries.
RTIs innovations continuously raise the bar of science and safety for biologics from being the first company to offer precision-tooled bone implants and assembled technology to maximize each gift of donation, to inventing validated sterilization processes that include viral inactivation steps. These processes BioCleanse®, Tutoplast® and Cancelle" SP DBM have a combined record of more than four million implants distributed with zero incidence of implant-associated infection. These processes have been validated by tissue type to inactivate or remove viruses, bacteria, fungi and spores from the tissue while maintaining biocompatibility and functionality.
RTIs worldwide corporate headquarters are located in Alachua, Fla., with international locations in Germany and France. The company is accredited by the American Association of Tissue Banks in the United States and is a member of AdvaMed.
RTI Biologics Inc.
Jenny Highlander, APR, 386-418-8888
Manager, Corporate Communications
Source: RTI Biologics Inc.Copyright Business Wire 2013