Prescriptive Information

Indications: 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.

Contraindications: The OAS is contraindicated when the VIPERWIRE guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.

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 use device during spasm of the vessel.
  • 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.
  • Do not re-sterilize or re-use the VIPERWIRE guide wire or the guide wire torquer. If the VIPERWIRE guide wire or torquer is re-sterilized or re-used, the guide wire may not function properly potentially leading to serious infection and patient harm and/or death.
  • Never force the crown if any resistance is felt within the vessel as vessel perforation may occur. If resistance is felt, retract the crown, while monitoring the cause of the resistance, and immediately stop treatment. Use fluoroscopy to analyze the situation and to monitor the cause of the resistance.
  • Do not come within 5 mm of the proximal end of the VIPERWIRE guide wire spring tip with the distal end of the OAD drive shaft. If the distance between the shaft tip and the VIPERWIRE guide wire spring tip is insufficient, the shaft tip may contact the guide wire spring tip and result in dislodging the guide wire spring tip. Use fluoroscopy to monitor movement of the shaft tip in relation to the VIPERWIRE guide wire spring tip.
  • Immediately stop using any OAS component should mechanical failure of any component occur before or during the atherectomy procedure. Using damaged components may result in OAS malfunction or patient injury.
  • Immediately stop use of the OAD if the device stalls. Review for complications if a stall condition occurs. Do not change to high speed if a device stalls on low speed.
  • Initial treatment for each lesion must start at low speed.
  • Do not continue treatment if the wire or the device becomes subintimal.
  • Do not operate the OAD if there is a bend, kink, or tight loop in the VIPERWIRE guide wire. A bend, kink, or tight loop in the VIPERWIRE guide wire may cause damage to and malfunctioning of the device during use.
  • Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage.
  • Always keep the crown advancing or retracting, while it is rotating, by continually moving the control knob to ensure 1:1 movement between the control knob and the rotating crown.
  • Do not start or stop orbiting of the crown when tight in a lesion.
  • Once the OAD has reached full speed (as indicated by a stable pitch) do not allow the rotating crown to remain in one location as it may lead to vessel damage. Continue to maintain a maximum travel rate of 1 cm per second.
  • Maximum total treatment time should not exceed 5 minutes. If maximum total treatment time exceeds 5 minutes, the OAD shaft, crown, and VIPERWIRE guide wire may begin to exhibit signs of wear and result in a device malfunction and possible injury to patient. A team member should track run time during use to verify total run time is not exceeded.
  • Do not advance or retract the rotating crown by advancing the OAD sheath or handle. Buckling of the VIPERWIRE guide wire may occur resulting in vessel perforation or vascular trauma. Always advance the rotating crown by using the crown advancer knob.
  • Do not inject contrast solution into the OAD injection port. Device failure or patient harm may occur.
  • Do not allow body parts or clothing to come into contact with rotating components as the OAD rotates at very high speeds. Physical injury to the user or entanglement of clothing with the crown may occur.
  • The OAS was only evaluated in severely calcified lesions; therefore the scientific evidence to support use of the OAS to treat other types of lesions/patients is limited.

Precautions:

  • Do not use the OAD if there is damage to the OAD package or if the OAD has reached its shelf life expiration date
  • If using an adjustable hemostasis valve with the guide catheter, close the hemostasis valve to minimize blood loss from around the guide catheter while still allowing the OAD sheath to slide through the hemostasis valve. Avoid excessive tightening of the hemostasis valve to prevent damaging the OAD catheter sheath. When inserting or removing the OAD crown or drive shaft through the hemostasis valve, use care not to deform the drive shaft.
  • If 1:1 movement is not observed, retract and re-advance the crown into the lesion. Repeat retracting and advancing the crown into the lesion until 1:1 movement is observed. If the knob and the crown are not moving together, the crown may be driven into the lesion with too much force and lengthening of the OAD driveshaft may occur on exiting the lesion.
  • Follow standard institution atherectomy policies and procedures, including those related to anticoagulation and vasodilator therapy.
  • Always use fluoroscopy while introducing and advancing the VIPERWIRE guide wire within a vessel.
  • A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries due to the possible occurrence of electrophysiological alternations.
  • The risk of the occurrence of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment; therefore, on-site surgical back-up should be included as a clinical consideration.
  • Do not kink or crush the saline tubing as this will reduce the flow of saline and VIPERSLIDE Lubricant to the OAD.
  • Continually monitor and check the saline tubing and connections for leaks during the procedure.
  • Do not spin the crown while advancing or retracting the crown within a guide catheter. Damage to the guide catheter and/or OAD may occur.
  • Ensure the OAD strain relief remains straight during atherectomy treatment. If the OAD strain relief does not remain straight, the shaft/sheath can kink.
  • Do not sterilize the OAS pump. Sterilizing will damage the OAS pump. The OAS pump is intended to be used and maintained outside of the sterile field. See Section 10.3 for instructions on cleaning and disinfecting the OAS pump.
  • Do not allow fluid to leak onto electrical connections of the OAS pump.
  • Do not spin the crown when removing the OAD from the body as this can result in guide catheter or touhy damage.
  • Do not spin the crown without a seated and supportive guide catheter.
  • When treating from a larger lumen to a smaller lumen, make sure the guide catheter is coaxial and that the tip of the OAD has entered the coronary artery to control the initial orbit before engaging the crown; engage the OAD tip into the tight stenosis until low speed had reached its treatment potential prior to initiating treatment with high speed.
  • To relieve compression in the driveshaft, lock the crown advancer knob at 1cm from the full back position, advance device over wire to a position proximal from the lesion, deploy the guide wire brake, then unlock the crown advancer knob and move it fully proximal. If the OAD is started with existing compression in the driveshaft it may result in the crown springing forward.
  • Do not flip contents of tray into sterile field as damage may occur. Components within tray must be carefully removed and placed into sterile field to avoid damage.
  • Patients with an ejection fraction (EF) of less than 25% were not evaluated in the ORBIT II clinical study.

See the instructions for use before performing DIAMONDBACK 360 coronary orbital atherectomy procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.

 

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.