Diamondback 360® Coronary Orbital Atherectomy System


At CSI, we are a culture of innovation, driven by the understanding that smart design changes, no matter how small, can make a big difference at a critical moment – a difference that may make things simpler, deliver better outcomes or even save a life. We observe carefully, listen closely and collaborate extensively, seeking opportunities to help interventionalists do their jobs more easily and more effectively – all with the goal of improving patient care.




Gain greater confidence in your patients’ PCI outcomes when treating severely calcified coronary lesions.

Diamondback 360® Coronary OAS’s unique mechanism of action uses a patented combination of centrifugal force and differential sanding to safely and simply reduce arterial calcium, enabling successful stent delivery.

In the ORBIT II pivotal trial, the Diamondback 360® Coronary OAS demonstrated durable results with low TLR rate of 3.4% in DES subset* at one year.

*Subjects with DES only (N=389/443)

324,000+
Peripheral and Coronary Patients Served

OAS is the Smart Solution for Arterial Calcium

Coronary calcium tends to be underestimated. Calcium considered mild or moderate by angiography may actually be severe if advanced imaging such as IVUS or OCT are used.44  Moderate to severe arterial calcium is present in nearly 40% of patients who undergo a Percutaneous Coronary Intervention (PCI).1

 

PATIENT PREDICTORS OF ARTERIAL CALCIFICATION

  • Diabetes
  • Chronic Kidney Disease
  • Advanced Age (>65 y/o)
  • Smoker
  • Dyslipidemia
  • Hypertension
  • Prior CABG
  • Known PAD/CAD

 

CHALLENGES ASSOCIATED WITH CALCIUM

  • Prone to dissection during balloon angioplasty or pre-dilatation
  • Difficult to fully dilate the balloon
  • May prevent adequate stent expansion and apposition
  • May prevent stent delivery

 

 

See How Diamondback 360® Coronary OAS Reduces Arterial Calcium

Explore Diamondback 360® OAS

Hover over or click on a feature to learn more

  • Crowns
  • Accessories

Crowns

Classic Crown

The Diamondback 360® Coronary Orbital Atherectomy System utilizes a 1.25 mm eccentrically mounted diamond-coated crown:

  • Reduces calcium and allows the healthy tissue to flex away
  • Provides bi-directional sanding
  • Creates minuscule particulates (most smaller than a red blood cell)

GlideAssist® is the innovative solution that allows for tracking, easier removal and smoother repositioning of the device — especially in challenging anatomies.

The GlideAssist feature will allow users to spin the OAD at a slow rotational speed (5 kRPM) to facilitate easier tracking and removal of the OAD. The GlideAssist feature is available on the Classic Crown OAS only.

Enable GlideAssist Mode

  • Press and hold the low speed button.
  • Release the button once the low speed light begins to slowly blink. The slowly blinking light indicates GlideAssist mode is enabled.

Secure Guide Wire

  • Ensure the guide wire is secure by locking the brake or by holding the guide wire with either fingers or the guide wire torquer.

Spin in GlideAssist Mode

  • Press and release the On/Off button on top of the crown advancer knob to activate crown rotation.
  • The low speed light will rapidly blink, indicating the crown is spinning in GlideAssist mode.

Stop Spinning in GlideAssist Mode

  • Press and release the On/Off button to stop spinning.
  • The low speed light will slowly blink, indicating the device is no longer spinning, but continues to be in GlideAssist mode.

Disable GlideAssist Mode

  • Press and immediately release either the low or high speed button while the crown is not spinning.
  • The low speed light will stop blinking, yet remains illuminated, indicating the device is now in treatment mode.

Accessories

OAS Pump

The OAS Pump keeps pace with the evolving Cath Lab environment, focusing on safety, simple set up and ease of use. It mounts directly onto an I.V. pole and provides power and the pumping mechanism for the Diamondback 360® System.

ViperWire Advance® Coronary Guide Wire

ViperWire Advance Coronary Guide Wire was designed to be easy to use and to provide tactile feedback to increase physicians’ ability to navigate the wire throughout the vessel.

Customize treatment with two guide wire options: The ViperWire Advance stainless steel guide wire or ViperWire Advance with Flex Tip nitinol guide wire, with a stainless steel support coil which allows the tip to be shaped as needed.

 ViperWire with Flex TipViperWire Advanced
Core Material NitinolStainless Steel
Tip/Core Diameter.014/.012.014/.012
Tip Load/Type1.0g/floppy1.4g/floppy
Tip CharacteristicsSoft, Floppy, one piece core-to-tip Nitinol, with stainless steel support coil, shapeableIntermediate, one piece, core-to-tip shapable
Length325 cm325 cm

ViperWire Advance with Flex Tip’s flexible nitinol body was designed to reduce wire bias and kink resistance during coronary procedures. The stainless steel support coil provides a floppy, shapeable tip for navigation in multi-vessel coronary lesions.

  • Material/Body Type: Nitinol/flexible/kink resistance
  • Tip/Core Diameter: .014/.012
  • Tip Load/Type: 1.0g floppy
  • Tip Shapeability: Stainless steel support coil allows tip to be shaped as needed
  • ViperWire Advance with Flex Tip Model Number: GWC-12325LG-FT


Click to view Diamondback 360 Coronary OAS ordering guide

 


ViperSlide® Lubricant

ViperSlide is an exclusive lubricant for use with CSI® Orbital Atherectomy Systems. ViperSlide increases the lubricity, therefore reducing friction between the device and the ViperWire Advance® Guide Wire.

The Diamondback 360® has a unique Mechanism of Action designed to:

  • Treat 360° of the vessel wall
  • Provide continuous flow of blood and saline during orbit minimizing thermal injury
  • Treat 2-4 mm* vessels with a single crown through a 6 fr guide enabling radial access
*Based on minimum reference vessel diameter as determined by orbit testing in a carbon block model

Learn More

  • Warnings
  • Precautions

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.csihubstage.wpengine.com.

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