Device Dossier
ViperWire Advance Coronary Guide Wire with Flex tip - Catheter guide wire
Device Dossier for ViperWire Advance Coronary Guide Wire with Flex tip - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
The CSI Diamondback 360 Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions. The ViperWire Advance Coronary Guide Wires are intended for use with Diamondback Orbital Atherectomy Device (OAD) and intended use is in adults patients who are 18 years of age and older.
Functional description
The ViperWire with Flex tip guide wire is a smooth, nitinol wire, with a silicone coating, and a radiopague spring tip. The ViperWire guide wire allow for proper positioning of the OAD crown within coronary arteries and provides a center of rotation for the OAD drive shaft. The ViperWire guide wire torquer is an accessory, packaged with the ViperWire guide wires , and provides a gripping surface for manipulating the Viperwire guide wire.