RTI Biologics Inc. (RTIX), a provider of orthopedic and other biologic implants, said has received 510(k) clearance from the U.S. Food and Drug Administration or FDA for its porcine dermis implant. The implant is planned for use in soft tissue repair procedures such as hernia repair.
Stored hydrated and ready-to-use, the porcine dermis implant consists of non-crosslinked porcine dermis, designed to act as a scaffold that allows for neovascularization and reincorporation with the patient's own tissue.
The implant, would be made available in various shapes and sizes, is sterilized through the Tutoplast Tissue Sterilization Process, 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 company added that the implants would be processed at RTI's 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.
by RTT Staff Writer
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