![]() ![]() ![]() When treating such patients, physicians should be aware of this increased risk and consider available data and the limitations of such data. Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI or death. When DES are used outside the specified indications for Use, patient outcomes may differ from the results observed in the EVOLVE clinical trials.
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