The Smart Solution
For complex PCI patients
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Important Safety Information
FLEXIBLE TO THE CORE:
The first nitinol coronary atherectomy guide wire delivering a winning combination with nitinol core and stainless steel shapeable tip.
NEW NITINOL CORONARY GUIDE WIRE
Shapeable floppy tip and flexible nitinol body for navigation in complex anatomy
Flexible nitinol body providing reduced
wire bias in complex anatomy and improved kink resistance to allow for advanced vessel prep in severe calcium
Viperwire Advance with Flex Tip (Nitinol)
2 WIRE OPTIONS:
Viperwire Advance (Stainless Steel)
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
THE ORBITAL ADVANTAGE
Diamondback 360 Coronary Orbital Atherectomy System (OAS) reduces superficial calcium and facilitates fracture of medial calcium to optimize stent delivery, expansion and apposition:
Dual Mechanism of action
Bi-directional differential sanding
A deeper look
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The diamond-coated crown sands intimal calcium into particulate with an average size of approximately 2 μm—which is smaller than a capillary vessel.
The pulsatile impact of the crown may facilitate fracture of deep calcium.
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.
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Smarter software makes device power up effortless. Ramp up speed is now 2X faster and more efficient with second generation device.
one-touch Start Button
allows two-minute set up and provides efficient torque transfer to the shaft and crown.* Provides stability, predictability and consistency.
with a single crown through a 6 Fr guide
enabling radial access.
TREAT 2.5 TO 4.0 MM VESSELS
allow for quick speed adjustments within the sterile field.
CONVENIENT, TWO-SPEED CONTROLS
Orbiting diamond-coated crown combining bi-directional differential sanding and pulsatile force to safely, effectively and efficiently treat severely calcific lesions.
Treating severely Calcific Lesions
A single 1.25 mm crown treats vessels 2.5 to 4.0 mm through a 6 Fr access.
Reduce plaque while potentially minimizing damage to the medial layer of the vessel.
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.
*Set up times may vary.
*CSI Data on file
OPTIMIZING PROCEDURAL WORKFLOW
Designed to reduce procedural time with 5 easy steps:
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.
1. Enable GlideAssist Mode
2. Secure Guide Wire
3. Spin in GlideAssist Mode
4. Stop Spinning in GlideAssist Mode
5. Disable GlideAssist Mode
This feature enables the crown to spin at slow speed (5 kRPM) for easier tracking and removal of the device over the guide wire.*
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.
ORBITAL ATHERECTOMY BY THE NUMBERS
Real-World Angiographic Complications and 30-Day MI:
(Lee MS, et al. Study: real-world multi-center retrospective study.)
Slow flow/no reflow
(Chambers J, et al.: PMA pivotal trial that is core lab adjudicated with common protocol.)
Average fluoroscopy time
Average procedure time
(Kini A, et al.: Study assessing the mechanistic effect of RA & OA using OCT.)
STENT EXPANSION AND WALL APPOSITION:
Average stent expansion
TLR-rate at 1 year in DES patients
(Genereux P, et al. Am J Cardiol ORBIT II 1-year results.)
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
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
Dr. Emmanouil Brilakis, Abbott Northwestern Hospital, Minneapolis, MN
PHYSICIAN, FACILITY NAME:
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.
# of Passes
Ostial and Proximal LAD with OAS
3 runs on low for 15 seconds each
2 runs in the ostial and proximal lesion
1 run in just the proximal lesion
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.
• Treated LAD with OAS after Circumflex, endpoint was the treatment of LAD. OAS results at LAD was determined by angiogram.
• Stent deployment went well and was well opposed. Stents used were 4.0x16 proximal LAD and 4.5x15 Ostial LAD, post balloon was a 4.5x15 NC. Patient was sent to the ICU to be monitored for hypertension, but was alert and talking at the end of the case
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DIAMONDBACK 360 AT-A-GLANCE
Wire Option #1
ViperWire Advance Coronary Guide Wire – Flex Tip Option Now Available
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.
Wire Option #2
ViperSlide increases the lubricity, therefore reducing friction between the device and the ViperWire Advance Guide Wire
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.
Diamondback 360® OAS Device / Handle
1.25mm Eccentrically Mounted Diamond-Coated Crown:
Information & Specs
ORBITAL ATHERECTOMY DEVICE
125 mm Classic
0.012"/0.014" Flex Tip
5 per box
10 bags per box
100 mL Package
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.
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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