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March 13, 2014

RTI Surgical’s Fortiva porcine dermis obtains CE Mark approval

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.

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.

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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.

"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."

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.

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Find the right pricing strategy for your medical device

How do your competitors set prices in different markets? Will reducing your prices win market share from your main competitors? Do you need to position products differently for different markets? To find out, use our Global Brand Pricing tool to achieve optimal pricing for your devices. Detect price changes, understand competitor market positioning, and plan new product launches, by accessing this tool today. It features:
  • A proprietary algorithm that leverages numerous pricing sources, with an emphasis on real-world data
  • Estimates of the likely spread of selling prices per brand and manufacturer, as well as 3-year forecasts for prices
  • Medical device pricing data that can be tracked by market, company, and brand
  • Additional categories that can be built on a custom basis
Use our tool to access competitor pricing strategies across multiple geographies, and various dynamic case studies from the likes of Germany and China, to benchmark yourself against your competitors and future proof your pricing strategies.
by GlobalData
Enter your details here to receive your free Report.

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