(b)(4) clinical study.
It was reported that vessel dissection occurred.
In (b)(6) 2017, clinical status assessment identified the patient¿s qualifying condition as rutherford category 2.
The index procedure was performed on the same day.
The target lesion was located in the left superficial femoral artery had 99% stenosis, reference vessel diameter of 4.
76 mm, a length of 180 mm, and was classified as a tasc ii c lesion.
The lesion was treated with pre-dilatation using 5 mmx100mm balloon catheter and standard percutaneous transluminal angioplasty (pta) was performed with a 6.
0mmx220mmx150cm (4f) sterling¿ balloon catheter to treat the target lesion.
Post deployment of sterling¿ pta balloon, dissection b was noted and no action was taken for the same.
Two days post procedure, the patient was discharged on aspirin and clopidogrel.
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