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
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
- Chronic Kidney Disease
- Advanced Age (>65 y/o)
- 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
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
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.
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*