Interventional device developer Cardiovascular Systems (CSI) of Minneapolis has received 510(k) marketing clearance from the U.S. Food and Drug Administration for its orbital atherectomy device to remove tissue-causing stenosis in synthetic AV shunts.
The product utilizes a diamond-coated eccentrically rotating cutting surface to ablate tissue in synthetic AV shunts used for vascular access in hemodialysis patients. The firm said it expects to conduct initial market testing at a limited number of clinical sites before having a full commercial release of the product for treating AV shunts.
In addition, CSI said it is working on obtaining FDA clearance for use of the device in peripheral vascular disease, and approval for use in coronary arteries.
In related news, the vendor said it has received conditional approval from the Freiburg Ethics Commission in Freiburg, Germany, to commence a clinical study of its orbital atherectomy device for the treatment of peripheral vascular disease in Europe. The trial will receive unconditional approval following CSI's notification to the commission of its German insurance carrier, the company said.
The clinical study will include up to 65 patients at up to four European investigational sites. CSI said it anticipates the trial will start in Frankfurt, Germany, later this month.
By AuntMinnie.com staff writers
February 3, 2005
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