English to Russian Other Medical: Cardiology

Although not a statistically significant difference and these values were not clinically significant, the FDA was concerned with the elevations in troponin I levels which is a sensitive and specific surrogate marker for myocardial cell necrosis most likely, due in this case, to excessive lead tip heating. Device resets themselves are benign; however, the FDA editorial specifically called out the device reset data, the reed switch fixed rate data and the serum troponin I data as outcomes with implications that “are of concern.”