Diamondback 360™

Coronary Orbital Atherectomy System

Diamondback 360 product

Treat with Confidence

Diamondback 360™ Orbital Atherectomy System

Take a calculated approach when treating severely calcified coronary lesions—gaining greater confidence in your Percutaneous Coronary Intervention (PCI) outcomes.

Diamondback 360™ Coronary Orbital Atherectomy System's (OAS) 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.1

In the ORBIT II pivotal trial, the Diamondback 360™ Coronary OAS demonstrated durable results with low target lesion revascularization (TLR) rate of 3.4% in drug-eluting stent (DES) subset* at one year.2
 

OAS is a First-line Approach for Severe Arterial Calcium

Coronary calcium tends to be underestimated. Calcium considered mild or moderate by angiography may actually be severe if advanced imaging such as intravascular ultrasound (IVUS) or optical coherence tomography (OCT) imaging are used.3,4 Moderate to severe arterial calcium is present in 30-40% of patients who undergo a PCI.4,5

Patient Predictors of Arterial Calcification6

  • Diabetes
  • Chronic Kidney Disease
  • Advanced Age (>65 y/o)
  • Smoker
  • Dyslipidemia
  • Hypertension
  • Prior Coronary Artery Bypass Graft (CABG)
  • Known Peripheral Artery Disease (PAD)/Coronary Artery Disease (CAD)
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physician in a blue cap wearing a blue mask physician in a blue cap wearing a blue mask

Challenges Associated with Calcium6

  • 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
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Diamondback 360™ OAS has a Unique Dual Mechanism of Action Design

  • The diamond-coated crown sands intimal calcium into particulate with an average size of approximately 2 μm7—which is smaller than a capillary vessel.
  • With a particulate size of 2 µmand continuous blood flow during orbit, Diamondback 360™ OAS may reduce risk of slow flow and no reflow.6,7
  • A single 1.25 mm crown treats vessels 2.5 mm to 4.0 mm1 through a 6 Fr access.8
  • The pulsatile impact of the crown against deep plaque can create microfractures that modify deep calcium.6,9†
Diamonback 360

*Subjects with DES only (N=389/443).
United States Patent #: 10,299,820

 

References

  1. Chambers JW, et al. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv. 2014;7(5):510-518.
  2. Généreux P, et al. Orbital atherectomy for treating de novo severely calcified coronary narrowing (1-year results from the pivotal ORBIT II trial). Am J Cardiol. 2015;115(12):1685-1690.
  3. Mintz GS. Intravascular imaging of coronary calcification and its clinical implications. JACC Cardiovasc Imaging. 2015;8(4):461-471.
  4. Mintz GS, et al. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995;91(7):1959-1965.
  5. Genereux P, et al. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014;63(18):1845-1854.
  6. Shlofmitz E, et al. Orbital atherectomy for the treatment of severely calcified coronary lesions: evidence, technique, and best practices. Expert Rev Med Devices. 2017;14(11):867-879.
  7. Sotomi Y, et al. Patient Selection and Procedural Considerations for Coronary Orbital Atherectomy System. Interv Cardiol. 2016;11(1):33-38.
  8. Shlofmitz E, et al. Lesion Preparation with Orbital Atherectomy. Interventional Cardiology Review 019;14(3):169–173.
  9. Yamamoto M, et al. Effect of orbital atherectomy in calcified coronary artery lesions as assessed by optical coherence tomography. Catheter Cardiovasc Interv. 2019;93(7):1211-1218.

MAT-2310616 v1.0

Important Safety Information

Diamondback 360™ and Diamondback 360 Precision™ Coronary Orbital Atherectomy System

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Including the Orbital Atherectomy Device (OAD) with GlideAssist™, Saline Pump, ViperWire Advance™ Coronary Guide Wire, and ViperWire Advance™ with Flex Tip Coronary Guide Wire

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

Use of the OAS is contraindicated for use 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.

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. Contact a CSI representative for information on training.
  • Do not use other commercially-available guide wires with the OAD. Only use the Model GWC-12325LG-FLP ViperWire Advance™ Coronary Guide Wire or GWC- 12325LG-FT ViperWire Advance™ Coronary Guide Wire with Flex Tip 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 use force to advance the spinning crown as vessel perforation may occur. If any resistance to crown travel is felt, reposition the crown away from the lesion, immediately stop treatment, and use fluoroscopy to assess the vessel for any complications. If it is confirmed there are no complications, reposition the device and advance and retract at a targeted rate of 1 to 3 mm per second.
  • Use fluoroscopy to monitor and maintain spacing between the driveshaft and guide wire spring tip throughout the procedure. Always keep more than 5mm of spacing between the distal end of the OAD driveshaft and the proximal end of the guide wire spring tip. If the distance between the driveshaft tip and the ViperWire™ guide wire spring tip is insufficient, the driveshaft tip may contact the guide wire spring tip and result in dislodging the 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 device stalls on low speed.
    • Note: If a stall occurs, the On/Off button is inactive for five seconds. If the On/Off button is pressed during this five second lockout period, the lockout period will begin again.
  • 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 or angulated vessels or bifurcations may result in vessel damage or device failure requiring retrieval.
  • Always keep the crown advancing or retracting, while it is orbiting, by continually moving the crown advancer knob to ensure corresponding (1:1) movement between the crown advancer knob and the orbiting 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) continue to maintain a targeted travel rate of 1 to 3 mm per second, and do not exceed 10 mm per second. If the orbiting crown remains in one location it may lead to vessel damage.
  • 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 orbiting 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 orbiting 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 attempt aspiration through the OAD or saline line while placed within the body. If saline is pulled out through the OAD or saline line, air may enter the system.
  • If air is noticed in the system while the OAD is within the body, discontinue treatment by pressing the OAS Pump power button and carefully remove the OAD driveshaft and crown from the introducer sheath/guide catheter.
  • Do not allow body parts or clothing to come into contact with spinning components as the OAD orbits 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.
  • Do not spin the crown in GlideAssist™, with the guide wire brake lever in the unlocked position, without first securing the guide wire by holding it with fingers or by using the guide wire torquer. If using the guide wire torquer, ensure that it is securely fastened to the guide wire before starting to spin the crown. Failure to secure the guide wire when the brake is unlocked could allow the guide wire to spin while in GlideAssist™ mode which may result in patient harm.

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 crown and crown advancer knob movements are not moving correspondingly with one another (1:1 movement), retract and re-advance the crown into the lesion using a travel rate between 1 to 3 mm per second. Repeat retracting and advancing the crown into the lesion until crown to crown advancer knob movement correspondence 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 may result in the crown springing forward on exiting the lesion.
  • Follow standard institution atherectomy policies and procedures, including those related to anticoagulation, channel blockers, and vasodilator therapy.
  • Ensure fluoroscopy provides adequate visualization of the OAS system. Always use fluoroscopy to monitor the guide wire spring tip and driveshaft positions at all times throughout the procedure. If wire movement occurs, it is suggested to reposition the guide wire before advancing the device or continuing treatment.
  • Applies to Diamondback 360™ Precision Coronary OAS only: Verify that contrast media injections are not above 400 psi and are not occurring during spinning of the crown.
  • Applies to Diamondback 360™ Precision Coronary OAS only: If using a guide catheter smaller than 0.071 inches (1.80 mm), contrast media flow may be reduced.
  • 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. If onsite surgical back-up is not provided, then an agreement with an alternative hospital should be considered, in advance of the procedure, where the patient could be transferred in an emergency situation.
  • 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 or tuohy. Damage to the guide catheter, tuohy, 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. Reference the Instructions for Use 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 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 has 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.
  • Ejection fractions less than 25% have not been studied, use with low ejection fractions may require additional precautions due to compromised heart function.

POTENTIAL ADVERSE EVENTS

Potential adverse events that may occur and/or require intervention include, but are not limited to:

  • Allergic reaction to medication/media/device components. Aneurysm. Angina (ischemic chest pain). Arrhythmias. Arteriovenous fistula. Bleeding. Bruising/hematoma. Cardiac/cardiopulmonary arrest. Cardiac/pericardial tamponade. Cerebrovascular accident (CVA). Death. Embolization, distal (air, tissue, thrombus, device). Emergent coronary artery bypass graft surgery (CABG). Failure to deliver the system to the intended locations. Fever. Heart failure/dysfunction. Hemorrhage, requiring transfusion. Hypotension/hypertension. Infection. Myocardial infarction. Pain. Pericardial effusion. Pseudoaneurysm. Restenosis of treated segment leading to revascularization. Renal insufficiency/failure. Shock (cardiogenic, hypovolemic). Slow flow or no reflow phenomenon. Stroke. Thrombus. Vessel closure, abrupt. Vessel injury, requiring surgical repair. Vessel dissection, perforation, rupture, or spasm. Vessel occlusion.


Diamondback 360™ and Diamondback 360 Precision™ Coronary Orbital Atherectomy System are manufactured and distributed by Cardiovascular Systems, Inc. (CSI). CSI is a subsidiary of the Abbott Group of Companies.

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