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January 18, 2010
Data Presented on Cook's REFORM Trial at ISET
January 19, 2010—Cook Medical (Bloomington, IN) announced that findings from the REFORM clinical trial were presented by Robert Bersin, MD, at the ISET 2010: International Symposium on Endovascular Therapy in Hollywood, Florida. REFORM is evaluating Cook's Formula balloon expandable stent for the long-term treatment of renal artery stenosis after suboptimal angioplasty.
According to the company, early data from the single-arm, 100-patient study suggest high technical and procedural success rates, clinically significant reductions in systolic blood pressure at 1 month, stable renal function, and no evidence of safety concerns. Clinical follow-up will continue through 3 years. Enrollment for the European arm of a trial evaluating a drug-eluting version of the Formula stent for renal indications was announced at the LINC 2010: Leipzig Interventional Course meeting held in Germany on January 27-30, 2010.
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