Cardiovascular Systems to expand US PAD (peripheral arterial disease) trial of atherectomy system:
This article was originally published in Clinica
The US FDA has given Cardiovascular Systems the all clear to expand a clinical trial of its Orbital Atherectomy System (OAS) in the removal of plaque from peripheral arteries. The OASIS study is the first prospective, multicentre, clinical trial for an atherectomy device treating peripheral arterial disease (PAD), claims the St Paul, Minnesota firm; the first OASIS trial patient was enrolled in January 2006. OAS is a catheter-based system that uses a diamond-coated crown to remove plaque, creating a final lumen that is around twice the size of the crown. It is already approved in the US for treating occluded AV grafts used in haemodialysis access, and it is cleared in Europe for the peripheral vascular indication.