(PDF) RX Herculink Elite® renal stent system | 合法醫療器材資訊網

2020年12月16日—TheHerculinkEliteisthemostrecentlyapprovedoftherenalstents,havingreceivedapprovalinlate2011.TheHerculinkElitestentistheonly ...

Medical Devices: Evidence and Research 2012:5

approved for treating RAS. This represents a step forward

compared to simply using a 510(k) pathway to approve a

biliary stent with the ultimate intent of using it in the vascular

system; however, there is still progress to be made. Specifi-

cally, the REFORM and HERCULES trials used predefined

objective performance criteria rather than an active control.

While this provides data that the devices are safe and effective

for reducing a renal artery narrowing, it does little to show

that clinical outcomes are improved.

Future perspectives

Currently, the clinical utility of stenting for RAS remains

incompletely defined, although trials such as CORAL and

RADAR will ultimately provide additional clarification of ...