Diamondback 360® Coronary Orbital Atherectomy System

TREAT WITH CONFIDENCE – Be Calculated™ with the proven Diamondback 360 Orbital Atherectomy System.

Take a calculated approach when treating severely calcified coronary lesions – gaining greater confidence in your patients’ 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.

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.⁸

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

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.

INSTRUCTIONS FOR USE

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CODING & REIMBURSEMENT

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.⁴⁴ Moderate to severe arterial calcium is present in nearly 40% of patients who undergo a PCI.¹

PATIENT PREDICTORS OF ARTERIAL CALCIFICATION⁵¹

Diabetes
Chronic Kidney Disease
Advanced Age (>65 y/o)
Smoker
Dyslipidemia
Hypertension
Prior Coronary Artery Bypass Graft (CABG)
Known Peripheral Artery Disease (PAD)/CAD

CHALLENGES ASSOCIATED WITH CALCIUM⁵¹

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

Explore Diamondback 360 OAS

Hover over or click on a feature to learn more

GlideAssist^® Mode

GlideAssist enables the crown to spin at a slow speed (5K RPM), reducing friction in the system to*:

Facilitate tracking of the device
Provide easier removal of the device
Allow smoother repositioning of the ViperWire Advance^® during procedures

Crowns

Classic Crown

The Diamondback 360 Coronary OAS utilizes a 1.25 mm eccentrically mounted diamond-coated crown:

Reduces severe calcium and allows the healthy tissue to flex away
Provides bi-directional sanding
Creates minuscule particulates (most smaller than a red blood cell⁵¹)

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

Accessories

ViperWire Advance Coronary Guide Wire

ViperWire Advance Coronary Guide Wire was designed to be easy to use and to provide the 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 Advance with Flex Tip	ViperWire Advance
Core Material	Nitinol	Stainless Steel
Tip/Core Diameter	.014/.012	.014/.012
Tip Load/Type	1.0g/floppy	1.4g/floppy
Tip Characteristics	Soft, Floppy, one piece core-to-tip, with stainless steel support coil, shapeable	Intermediate, one piece, core-to-tip shapable
Length	325 cm	325 cm

LEARN MORE ABOUT THE NEW VIPERWIRE ADVANCE WITH FLEX TIP

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 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

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 intravenous pole and provides power and the pumping mechanism for the Diamondback 360 System.

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.

CLICK TO VIEW DIAMONDBACK 360 CORONARY OAS ORDERING GUIDE

Be Calculated with the Diamondback 360 has a unique dual Mechanism of Action designed:

With a particulate size of 2 µm—smaller than a capillary vessel—and continuous blood flow during orbit, Diamondback 360 may reduce risk of slow flow and no reflow.^51,⁵²
A single 6 Fr 1.25 mm crown treats vessels 2.5 mm to 4.0 mm through a 6 Fr access.⁵³
The diamond-coated crown sands intimal calcium into particulate with an average size of approximately 2 μm—which is smaller than a capillary vessel.¹⁰
The pulsatile impact of the crown against deep plaque can create microfractures that modify deep calcium.^51,^52,^61,62*

^{* United States Patent #: 10,299,820}

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Clinical Evidence

INDICATIONS & IMPORTANT SAFETY INFORMATION

DIAMONDBACK 360^® Coronary Orbital Atherectomy System (OAS)
Indication: To facilitate stent delivery in patients with coronary artery disease 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 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. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.
CSI^® Peripheral Orbital Atherectomy System
Indications: For use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae.
Contraindications: The Systems are contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present.
Adverse Events: Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

1-877-CSI-0360

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Diamondback 360® Coronary Orbital Atherectomy System

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

OAS is a First-line Approach for Severe Arterial Calcium

PATIENT PREDICTORS OF ARTERIAL CALCIFICATION51

CHALLENGES ASSOCIATED WITH CALCIUM51

Explore Diamondback 360 OAS

GlideAssist® Mode

*CSI Data on file

Crowns

Classic Crown

Accessories

ViperWire Advance Coronary Guide Wire

OAS Pump

ViperSlide® Lubricant

Be Calculated with the Diamondback 360 has a unique dual Mechanism of Action designed:

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Clinical Evidence

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11/29/2021 16:00:00
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Diamondback 360^® Coronary Orbital Atherectomy System

PATIENT PREDICTORS OF ARTERIAL CALCIFICATION⁵¹

CHALLENGES ASSOCIATED WITH CALCIUM⁵¹

GlideAssist^® Mode

ViperSlide^® Lubricant