Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
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Note: Please refer to the VIPERSLIDE Lubricant IFU prior to starting the
atherectomy procedure.
2. Indications for use
The 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.
3. Contraindications
Use of the OAS is contraindicated in the following situations:
The VIPERWIRE guide wire cannot pass across the coronary lesion.
The target lesion is within a bypass graft or stent.
The patient is not an appropriate candidate for bypass surgery, angioplasty, or
atherectomy therapy.
The patient has angiographic evidence of thrombus.
The patient has only one open vessel.
The patient has angiographic evidence of significant dissection at the treatment site.
Women who are pregnant or children.
4. Warnings
Do not use the OAS if the physician does not have experience in coronary angioplasty
at their institution.
Do not use the OAS if the physician does not have training on using the OAS.
Do not use other commercially-available guide wires with the OAD. Only use the
Model GWC-12325LG-FLP VIPERWIRE Advance Coronary Guide Wire with the
coronary OAD. The VIPERWIRE guide wire is designed for use with all coronary OAD
crown and shaft configurations.
Never operate the OAD without normal saline and VIPERSLIDE lubricant. Continually
flowing saline and VIPERSLIDE lubricant is required for cooling and lubricating the
OAD during use in order to avoid overheating and permanent damage to the device
and possible injury to the patient.
Do not use the OAD or the VIPERWIRE guide wire if their sterile package barriers are
compromised or damaged.
Do not re-sterilize or re-use the OAD. If the OAD is re-sterilized or re-used, the OAD
may not function properly potentially leading to serious infection and patient harm
and/or death.