RTI Surgical Receives CE Mark Approval for Fortiva Porcine Dermis

RTI Surgical Inc. has received CE Mark approval for its Fortiva Porcine Dermis and will begin distributing the product throughout Europe.

Fortiva received 510(k) clearance from the U.S. Food and Drug and Administration (FDA) in March 2013 and was launched in the United States in July 2013. The implant is manufactured at RTI’s Neunkirchen, Germany facility.

“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.”

Fortiva porcine dermis is 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. The implant is designed to repair 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. Fortiva also improves O.R. efficiency, featuring 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 centimeters, 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.

Based in Alachua, Fla., RTI Surgical develops biologic, metal and synthetic implants used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures. The company operates four manufacturing facilities throughout the United States and Europe, and distributes its products in nearly 50 countries.