The study enrolls 100 patients at seven investigative sites throughout the US and the initial data were compiled at nine months post-procedure and benchmarked against well-established performance data.
Cook Medical said the data reveals a nine-month primary patency rate of 89.5% and a 97% rate of successful delivery and deployment of the stent.
The study’s principal investigator Bersin said the data for the Reform clinical trial reflect the clinical performance and patency of the renal stent platform and the initial data indicate that the balloon-expandable stent may offer a new treatment option for patients suffering from renal artery blockages.