![]() Safety Issues Impact Medtronic Spine Business In addition, there are no well-controlled studies in pregnant women, and there are concerns as to the safety and effectiveness of the device, which is not yet established in nursing women. According to this study, the rhBMP-2 extracts antibodies that are capable of crossing the placenta, which becomes a threat to the fetus. In addition, the product may have a potential risk for pregnant women due to its active ingredients based on an experimental rabbit study. The most common and serious adverse events associated with Infuse include cancer, bone and nerve injury, male infertility, infection and urinary problems. This product, however, has been associated with a series of side effects that led patients and physicians to seek other treatment options available in the market. Infuse is often used in replacement of autograft, which involves harvesting bone from the patient's own hip, and can be more painful for the patients and usually requires more healing time. ![]() The product is commonly placed within a spinal cage which is implanted into the spine. The powdered protein is mixed with sterilized water and is then applied over the sponge. The material is made up of two parts: recombinant human bone morphogenetic protein (rhBMP-2) and a sponge fabricated from cow collagen. The Infuse Bone Graft is a biologic for bone growth and is heavily used off-label for spinal fusions. Independent research studies from Yale University also confirmed that Infuse has certain risks that must be evaluated carefully by both physicians and patients before use. But, the product has been losing market share due to safety issues, which has resulted in significant impact on the company's spine business. Medtronic's Infuse Bone Graft market dominance in bone grafting. For a full report please contact: That Dilute Market Dominance Infuse revenues were down 11% for the second quarter, leaving an opportunity for other players to pick up MDT's lost market share. We believe that market share for Medtronic's ( NYSE: MDT) Infuse will continue to be soft in the market, allowing other players to chip at its market share.
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