RTI Surgical has obtained CE Mark approval for Fortiva porcine dermis, a non-crosslinked acellular porcine dermal matrix intended for use as a soft tissue path to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
Manufactured at RTI Surgical’s Neunkirchen facility in Germany, Fortiva porcine dermis is ready-to-use and requires no rehydration or rinsing. Fortiva 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.
The implant also aids in efficiency in the operation room (OR), with a temperature indicator for quick indication of proper storage, rounded corners for ease of suturing and consistent thickness. It is available in a broad array of sizes, including 35x35cm.
Fortiva implants are processed through RTI’s Tutoplast tissue sterilization process and terminally sterilized through validated low temperature, low dose gamma irradiation to achieve a sterility assurance level (SAL) of 10-6. Tutoplast tissue sterilization process is a validated chemical sterilization process that thoroughly penetrates tissue, removing antigenicity and inactivating pathogens.
RTI Surgical Europe managing director Stefan Seuferling noted Fortiva raises the bar in patient care and the company is very pleased that it will now be available in 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," Seuferling added.
With the CE Mark approval, RTI Surgical will begin the distribution of Fortiva porcine dermis throughout Europe. Fortiva obtained the US Food and Drug and Administration’s 510(k) approval in March 2013 and was launched in the country in July 2013.