Diamondback 360

Coronary calcium tends to be underestimated. Severe coronary calcium is present in 6 to 20% of patients undergoing PCI.1 2 Calcium considered mild or moderate by angiography may actually be severe in advanced imaging such as intravascular ultrasound (IVUS) or optical coherence tomography (OCT).3 Diamondback 360® Coronary Orbital Atherectomy Systems (OAS) reduces superficial calcium and fractures medial calcium for optimal stent delivery, expansion and apposition.7

BI-DIRECTIONAL DIFFERENTIAL SANDING

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PULSATILE FORCES

A DEEPER LOOK

Differential Sanding4

The diamond-coated crown sands intimal calcium into particulate with an average size of approximately 2 μm – which is smaller than a capillary vessel.

Pulsatile Forces1-4

The pulsatile impact of the crown may facilitate fracture of deep calcium.

Procedural Safety5

With the Diamondback 360® OAS, healthy tissue safely flexes away from the crown during operation, reducing impact to the medial layer. The orbital movement of the crown allows blood and saline to flow continuously during procedures, minimizing risk of thermal injury and slow flow/no reflow events.

TREATING SEVERELY CALCIFIC LESIONS

Orbiting diamond-coated crown combining bi-directional differential sanding and pulsatile force to safely, effectively and efficiently treat severely calcific lesions.4,5

A single 1.25 mm crown treats vessels 2.5 to 4.0 mm through a 6 Fr access.6

Reduce plaque while potentially minimizing damage to the medial layer of the vessel.4

With average particulate size of about 2 μm – smaller than a capillary vessel – and continuous blood flow during orbit, Diamondback 360® may reduce risk of slow flow and no reflow.4,5

INTRODUCING GLIDEASSIST®

OPTIMIZING PROCEDURAL WORKFLOW

This feature enables the crown to spin at slow speed (5 kRPM) for easier tracking and removal of the device over the guide wire.* *CSI Data on file

EASIER TRACKING AND REMOVAL

GlideAssist® is the innovative solution that allows for easier tracking and removal and smoother repositioning of the device – especially in challenging anatomies. Designed to reduce procedural time with 5 easy steps:

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1. Enable GlideAssist® Mode

2. Secure Guide Wire

3. Spin in GlideAssist® Mode

4. Stop Spinning in GlideAssist® Mode

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5. Disable GlideAssist® Mode

ORBITAL ATHERECTOMY BY THE NUMBERS

Prepping vessels first with the Diamondback 360® Coronary OAS can provide a wide variety of benefits ranging from streamlined procedures and optimal stent placement to durable patient outcomes and reduced costs.

Real-World Angiographic Complications and 30-Day MI:8

(Lee MS, et. al. Study: real-world multi-center retrospective study.)

Procedural Efficiency:7

(Chambers J, et al.: PMA pivotal trial that is core lab adjudicated with common protocol.)

18.2 min

Average fluoroscopy time

52.5 min

Average procedure time

Stent Expansion and Wall Apposition:9

(Kini A, et al.: Study assessing the mechanistic effect of RA & OA using OCT.)

Durable Outcomes:10

(Genereux P, et al. Am J Cardiol ORBIT II 1-year results.)

3.4%

TLR-rate at 1 year in DES patients

Reduced Cost:11

(Chambers J, et al.: PMA pivotal trial that is core lab adjudicated with common protocol.)

17%

Lower procedural cost with fewer complications and decreased length of stay compared to Medicare data and HORIZONS-AMI/ACUITY trials.

Note: These data points come from different studies that differ in terms of: treatment protocols, inclusion/exclusion criteria, patient populations, among other things. Physicians should draw their own conclusions based on the findings of the respective publications. For more information, contact your CSI sales representative, who can direct you to CSI Scientific Communications.

ORBITAL ATHERECTOMY CASE STUDY

Coronary Device Used:

Diamondback 360® 1.25 mm Classic Crown with Flex Tip

Physician, Facility Name:

Dr. Emmanouil Brilakis, Abbott Northwestern Hospital, Minneapolis, MN

Patient History:

87 yr white male, Diabetes, CAD, EF: 40%, BP mmHg: 136/81, Circumflex Lesion – thrombus versus calcium (per OCT it was thrombus), treated prior to LAD lesion

Treatment Details:

Lesion Location: Ostial and Proximal LAD with OAS Access Site: Femoral # of Passes: 3 runs on low for 15 seconds each 2 runs in the ostial and proximal lesion 1 run in just the proximal lesion

casestudy-preoas

Pre-OAS

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Post-OAS

Cine of lesion crossing with ViperWire® with Flex Tip

Femoral Access, 8 Fr EBU 3.75, primary wire was a Sion Blue (180 cm) and treatment strategy was to treat Proximal to Distal.

Case and images courtesy of Emmanouil Brilakis, MD, Abbott Northwestern Hospital, Minneapolis, MN. Dr. Brilakis is a consultant of CSI. The results from this case study may not be predictive for all patients. Results may vary.

DIAMONDBACK 360® AT-A-GLANCE

INFORMATION & SPECS

Diamondback 360® Orbital Atherectomy Device

MODEL NUMBERCROWN SIZESHAFT LENGTHQUANTITY
DBEC-125125 mm Classic135 cm1 each

ViperWire Advance® Coronary Guidewires

MODEL NUMBERSIZESHAFT LENGTHQUANTITY
GWC-12325LG-FLP0.012"/0.014" Tip325 cm5 per box
GWC-12325LG-FT0.012"/0.014" Flex Tip325 cm5 per box

ViperSlide® Lubricant

MODEL NUMBERDESCRIPTIONQUANTITY
VPR-SLD2100 mL Package10 bags per box

OAS Pump

MODEL NUMBERDESCRIPTIONQUANTITY
SIP-3000OAS Pump1 each

BRIEF STATEMENT

Indication: 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 Advance® Coronary 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/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated. 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.

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

References:

1. Généreux P, et al. J Am Coll Cardiol. 2014;63:1845-54.
2. Bourantas CV, et al. Heart. 2014;100:1158-64.
3. Mintz GS. JACC Cardiovasc Imaging. 2015;8:461-71.
4. Shlofmitz E, et al. Expert Rev Med Devices. 2017:14(11):867-879.
5. Sotomi Y, et al. Interv Cardiol. 2016;11(1):33-38.
6. CSI data on file: based on cadaver atheroschlerotic lesions, porcine coronary lesions and graphite block test models.
7. Chambers J, et al. JACC Cardiovasc Interv. 2014;7(5):510-518.
8. Lee MS, et al. J Interv Cardiol. 2016;29(4):357-362.
9. Kini A, et al. Catheter Cardiovasc Interv. 2015;86(6):1024-1032.
10. Genereux P, et al. Am J Cardiol 2015;115(12):1685-1690.
11. Chambers J, et al. Ther Adv Cardiovasc Dis. 2016;10(2):74-85.
12. CSI data on file: Zheng Y report

CSI, Diamondback 360, GlideAssist and Viperwire Advance are registered trademarks of Cardiovascular Systems.
© 2020 Cardiovascular Systems, Inc. EN-6344.A 0920

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