|Trade Name||BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM|
|Classification Name||stent, coronary|
|Generic Name||cardiovascular stent|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the labeling to the bestent(tm) 2 with discrete technology(tm) rapid exchange (rx) coronary stent delivery system. The device is now indicated for improving coronary luminal diameter in patients with synptomatic ischenic heart disease due to discrete de novo lesions (length <= 30 mm) in native coronary arteries with reference vessel diameters ranging from 3. 0 mm to 4. 0 mm. Long term outcome for this implant is unknown at present. The rapid exchange delivery system will allow for perfusion at an average rate of 2cc/min at nominal pressure during the 15-30 second stent deployment procedure only. The rapid exchange stent delivery system is not intended for use as a stand alone ptca perfusion catheter.