The first nitinol coronary atherectomy guide wire delivering a winning combination with nitinol core and stainless steel shapeable tip.
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
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
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.
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
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
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:
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.
(Lee MS, et. al. Study: real-world multi-center retrospective study.)
(Chambers J, et al.: PMA pivotal trial that is core lab adjudicated with common protocol.)
(Kini A, et al.: Study assessing the mechanistic effect of RA & OA using OCT.)
(Genereux P, et al. Am J Cardiol ORBIT II 1-year results.)
(Chambers J, et al.: PMA pivotal trial that is core lab adjudicated with common protocol.)
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.
Diamondback 360® 1.25 mm Classic Crown with Flex Tip
Dr. Emmanouil Brilakis, Abbott Northwestern Hospital, Minneapolis, MN
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
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
Pre-OAS
Post-OAS
Femoral Access, 8 Fr EBU 3.75, primary wire was a Sion Blue (180 cm) and treatment strategy was to treat Proximal to Distal.
MODEL NUMBER | CROWN SIZE | SHAFT LENGTH | QUANTITY |
---|---|---|---|
DBEC-125 | 125 mm Classic | 135 cm | 1 each |
MODEL NUMBER | SIZE | SHAFT LENGTH | QUANTITY |
---|---|---|---|
GWC-12325LG-FLP | 0.012"/0.014" Tip | 325 cm | 5 per box |
GWC-12325LG-FT | 0.012"/0.014" Flex Tip | 325 cm | 5 per box |
MODEL NUMBER | DESCRIPTION | QUANTITY |
---|---|---|
VPR-SLD2 | 100 mL Package | 10 bags per box |
MODEL NUMBER | DESCRIPTION | QUANTITY |
---|---|---|
SIP-3000 | OAS Pump | 1 each |
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.
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