Sunday, October 16, 2011

InQu Bone Graft Extender/Substitute Receive CE Mark Approval

InQu Bone Graft Extender/Substitute Receive CE Mark Approval: 09dsdrftgyuh

Bone grafting is one of the cornerstones of orthopaedic surgery. In cases like trauma, tumors, fusions and skeletal reconstruction there are often spaces and gaps that need to be filled in with bone. This is where bone grafting comes into play, and there are many options. The best bet is to use bone harvested from the patient, such as iliac crest bone graft from the pelvis. This is termed autograft and contains bone-producing stem-cells, growth factors and a structural scaffold to provide mechanical stability. In cases where a surgeon would like to avoid the pain and risk associated with harvesting bone, there are less invasive options. You can use bone obtained from organ donors, termed allograft (also less appropriately dubbed “croutons”). Allograft, however, carries the risk of infection and other transplant associated problems. Then there are bone graft substitutes/extenders, synthetic bioactive materials that provide a scaffold for healing bone to grow into. These usually are the least effective, however they can be combined with various modalities such as bone marrow aspirate to be a safe and effective (although more expensive) alternative to traditional bone grafting.

So in related news, ISTO just announced that their InQu Bone Graft extender/substitute material just received CE Mark approval (it received 510(k) clearance in the US in 2007). The product is somewhat unique, in that it combines polylactide-co-glycolide (PLGA) and unmodified hyaluronicacid (HyA), which are materials not commonly found in most commercially available bone graft substitutes. There is little research available regarding the effectiveness of this combination in skeletal surgery in the extremities, but it sounds promising. The PLGA is meant to provide an osteoconductive scaffold while the HyA improves handling, cell attachment and supports vascular ingrowth. It is designed for use in non-structural areas of bone, such as small voids from benign tumor excisions or hardware removals. The material is available as granules, a paste, putty and 3-dimensional structures.

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