Cardiovascular Systems Snags FDA Clearance for ViperWire
Cardiovascular Systems has won FDA 510(k) clearance for its ViperWire Advance peripheral guidewire with flex tip for use with the company’s peripheral orbital atherectomy systems.
The new guidewire features improved flexibility, navigation and ease-of-use when targeting calcium associated with peripheral artery disease, the St. Paul, Minn., devicemaker said Tuesday.
The product comes with a Nitinol support coil and a large proximal core for improved kink resistance. CSI plans to launch the device next month.
Up to 18 million Americans mainly 65 and older are afflicted with PAD, according to company estimates. — Jason Scott