RTI Surgical has received CE Mark approval for its Fortiva porcine dermis, a ready-to-use biologic implant that acts as a scaffold allowing for neovascularisation and permitting replacement of the implant with the patient’s tissue.
The implant is 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.
The non-crosslinked acellular porcine dermal matrix is indicated for use in repairing hernias and body wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
RTI Surgical Europe managing director Stefan Seuferling said: "Since its introduction in the US, we have seen the positive response from surgeons, and we are looking forward to offering this implant to surgeons here in Europe."
The ready-to-use porcine dermis requires no rehydration or rinsing and it 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 manufactured at RTI’s Neunkirchen, Germany facility and is available in a broad range of sizes, including 35×35 cm, which represents the largest biologics graft available in the market.
Fortiva is sterilised through RTI’s Tutoplast tissue sterilisation process and terminally sterilised via validated low-temperature, low-dose gamma irradiation to achieve a sterility assurance level (SAL) of 10-6.
Fortiva received 510(k) clearance from the US Food and Drug and Administration (FDA) in March 2013 and was launched in the US in July 2013.
The company also celebrated a milestone for Fortiva porcine dermis on May 23 2013, when a patient in Missouri received a 10x16cm graft for an incisional hernia repair using a component separation technique.