How Important Are FDA's Stent Approvals To Physicians?
Given the recent investigation by the US Department of Justice into the marketing of biliary stents for off-label uses in the peripheral vasculature, obtaining FDA approval for device use in specific arteries could become a key focus for stent manufacturers. A recent study conducted by Millennium Research Group at the Society of Interventional Radiology 33rd Annual Scientific Meeting in Washington, DC found that a significant portion of surveyed physicians would increase their use of biliary stents if the device received FDA approval for use in the peripheral vasculature; some physicians said their use could increase by as much as 50%.
Although stents on the market are only approved for use in the bile ducts, these stents have larger diameters than those used in coronary arteries, making them an attractive choice for physicians to use the peripheral arteries, such as the iliac artery. Once a stent has received pre-market approval from the FDA, physicians are free to use the stent off-label anywhere in the body; however, manufacturers can only promote the device for the specific indication(s) for which FDA approval has been granted.
Millennium Research Group's survey gauged the importance of FDA pre-market approval in physician decisions to use a particular stent brand, and also questioned physicians on whether or not they would be willing to pay a premium for a stent with artery-specific approval.
"The ability of a manufacturer to market FDA approval for a stent in a specific indication would provide physicians with increased confidence in the device's safety and efficacy," says Darren Navarro, Senior Analyst at Millennium Research Group. "Physician attitudes toward off-label use of stents may provoke new manufacturer initiatives to obtain artery-specific FDA approval. Furthermore, it may enable manufacturers to increase the price of their stents, growing revenues."