CE Mark for RTI Surgical’s Fortiva™ Porcine Dermis

Last summer we covered the U.S. approval, launch and first use of Fortiva™ Porcine Dermis from RTI Surgical Inc. Now the company has received CE mark approval for the product and says it will begin distribution throughout Europe.

Background

Manufactured at RTI’s Neunkirchen, Germany facility, Fortiva porcine dermis is a non-crosslinked acellular porcine dermal matrix intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. The implant is indicated for use in repairing hernias and/or body wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome. Fortiva porcine dermis is ready-to-use, requiring no rehydration or rinsing.

RTI says Fortiva also aids in efficiency in the OR, with a temperature indicator for quick indication of proper storage, rounded corners for ease of suturing and consistent thickness. The implant is available in a broad array of sizes, including 35×35 cm, which represents the largest biologics graft available today.

Fortiva is sterilized through RTI’s Tutoplast® Tissue Sterilization Process, a validated chemical sterilization process that thoroughly penetrates tissue, removing antigenicity and inactivating pathogens. Terminal sterilization using low dose gamma irradiation achieves a sterility assurance level (SAL) of 10-6.

Company comments

“Fortiva raises the bar in patient care and we are very pleased that it will now be available in Europe,” said Stefan Seuferling, managing director of RTI Surgical Europe. “Since its introduction in the U.S., we have seen the positive response from surgeons, and we are looking forward to offering this implant to surgeons here in Europe.”

Source: RTI Surgical Inc., Business Wire

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