The FDA is studying new wire mesh heart stents that can shrink or lengthen after implantation, according to a Reuter's report.
This defect is most common in the Promus and Ion devices made by Boston Scientific, the agency said. Factors that increase the risk for the complication include calcification of coronary arteries, implantation in a twisted blood vessel and improper positioning of the stent.
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This defect is most common in the Promus and Ion devices made by Boston Scientific, the agency said. Factors that increase the risk for the complication include calcification of coronary arteries, implantation in a twisted blood vessel and improper positioning of the stent.
Related Articles on Medical Devices:
FDA's Dr. Jeffrey Shuren Speaks to Congress About Medical Device Approval
Consumers Union Asks Congress to Strengthen Medical Device Oversight
FDA Opens Comment Period on Device Reclassification Process