Cook Medical Granted Approval to Initiate Reform Clinical Trial
Posted on: Thursday, 20 March 2008, 06:00 CDT
Cook Medical has announced that the FDA has approved initiation of the Reform clinical trial to evaluate the Formula Balloon Expandable Stent for the treatment of renal artery stenosis.
The trial's primary purpose is to evaluate the safety and effectiveness of the Formula Balloon Expandable Stent for the treatment of renal artery atherosclerosis against well-established performance data. The trial will enroll up to 100 patients at up to 30 investigative sites through the US and initial results are expected to be available in second quarter of 2010.
Rob Lyles, global leader of Cook Medical's peripheral intervention products division, said: "This study will give us an excellent opportunity to characterize the impact of the Formula Balloon Expandable Stent on renal artery revascularization and related clinical outcomes."
Source: Datamonitor
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