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Medtronic is sponsoring a series of new clinical tests of its controversial genetically engineered bone-growth product Infuse in an effort to gather long-term data about the optimal dose of the chemical in fusing spine bones to treat lower back pain.
Back pain is one the most common reasons Americans visit the doctor, and Infuse has been used widely to fuse bones that are painful when they move. But since the product was first approved in 2002 by the Food and Drug Administration, spine surgeons have mainly used Infuse in surgical applications that were not considered for safety by the FDA, including surgeries from a rear or “posterior” surgical approach, according to peer-reviewed studies.
Now Medtronic wants to gather data on two of the unapproved procedures: PLF, or posterolateral fusion of lower-back vertebrae using fixation hardware that attaches to the back of the bones; and TLIF, or transforaminal lumbar interbody fusion, in which a device is placed between the vertebrae being fused. Both experimental surgeries will use the chemical component of Infuse, a highly concentrated version of the naturally occurring human protein that causes bone growth.
Medtronic officials said Tuesday that the first of a planned 125 patients has been enrolled in the Infuse dosing study for PLF, which will be followed by the dosing study next year for TLIF.
For Further Information
More on the orthopedic biomaterials market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Biomaterials. This report covers the following market segments: orthopedic bone graft substitutes, orthopedic growth factors, orthopedic stem cell therapy, orthopedic hyaluronic acid viscosupplementations, orthopedic cartilage repairs, and spinal machined bone allografts.
The iData series on the market for orthopedic biomaterials covers the U.S., Japan, South Korea, Australia, China, and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedic biomaterials device market data or procedure data, register online or email us at [email protected] for an U.S. Market Report Suite for Orthopedic Biomaterials brochure and synopsis.