Certain 1 year rates updated at 3-year data extract.

* Based on reported CK-MB>3X ULN † Subjects with DES only (N = 389/443).

1-YEAR2

0

5%

10%

15%

20%

MI*

10.6%

TVR/TLR

5.8%

CardiacDeath

3.2%

MACE

16.9%

0

5%

10%

15%

9.7%

MI*

1.4%

TVR/TLR

0.2%

CardiacDeath

10.4%

MACE

30-DAY1

Successful Stent Delivered: 97.7%

Less than 50% Residual Stenosis 98.6%

3.4%TLR in DES

subset†

ORBIT II: Outcomes

EXPECT MORE FROM DIAMONDBACK. LIKE EVIDENCE.

THE SMART SOLUTION FOR

SEVERE CALCIUM.

CSI, Diamondback 360, ViperWire Advance and ViperSlide are registered trademarks of

Cardiovascular Systems, Inc. ©2016 Cardiovascular Systems, Inc. EN-1595.E 0916

ORBIT II was a prospective, multi-center study evaluating 443 patients with severely calcified coronary lesions treated with the Diamondback 360 OAS prior to stent implantation. ORBIT II met the primary safety and efficacy endpoints by a significant margin.

1 Chambers JW, et al. JACC Cardiovasc Interv. 2014;7(5):510-8.2 Généreux P, et al., Am J Cardiol. 2015 Jun 15;115(12):1685-90.

THE DIAMONDBACK 360® SYSTEMEVERYTHING YOU NEED.

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 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.

VIPERWIRE ADVANCE® CORONARY GUIDE WIRE

MODEL NUMBER DESCRIPTION LENGTH QTY

GWC-12325LG-FLP 0.012"/0.014" tip 325 cm 5

DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

MODEL NUMBER CROWN SIZE LENGTH QTY

DBEC-125 1.25 mm 135 cm 1

VIPERSLIDE® LUBRICANT

MODEL NUMBER DESCRIPTION QTY

VPR-SLD2 100 mL Bag 10

OAS PUMP

MODEL NUMBER DESCRIPTION QTY

SIP-3000 OAS Pump 1

For more information, please contact your local CSI representative or call customer service at 1-877-274-0901.

T: 651.259.1600 F: 612.677.3355

877.274.0901 www.csi360.com

1225 Old Hwy 8 NW

St. Paul, MN 55112

3 Mintz DS, Popma JJ, Pichard AD, et al. Circulation. 1995 Apr 1;91(7):1959-65.4 Genereux P, et al. J Am Coll Cardiol. 2014;63:1845-54.5 Bourantas CV, et al. Heart 2014;100:1158-64.

DON’T LET CALCIUMTAKE YOU BY SURPRISE.

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) are used.3 Severe coronary calcium is present in 6-20% of patients undergoing PCI.4,5

MAKING EVEN COMPLEX CASES

FEEL ROUTINE.Diamondback 360® Coronary Orbital Atherectomy System (OAS) reduces severe calcium, enabling successful stent delivery to help optimize stent expansion and PCI outcomes.

EASY SET-UP AND USE THAT’S DIAMONDBACK 360.

Diamondback 360 Coronary OAS features:

• Quick and easy set up in <2 minutes

• Electric powered handle

• Starts with one touch, making device power up effortless

• Convenient two-speed controls on the handle to allow for quick speed adjustments within the sterile field.

ORBITAL: THE SMART SOLUTION FOR SEVERE CALCIUM.

The Diamondback 360 has a unique Mechanism of Action designed to:

• Treat 360° of the vessel for improved vessel compliance

• Provide continuous flow of blood and saline during orbit minimizing thermal injury

• Treat 2-4 mm vessels with a single crown through a 6 Fr sheath

The 1.25 mm eccentrically mounted diamond coated crown:

• Reduces calcium and allows the healthy tissue to flex away

• Provides bi-directional sanding

• Creates minuscule particulates smaller than a red blood cell

VIPERWIRE ADVANCE

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.

VIPERSLIDE

ViperSlide® is an exclusive lubricant for use with CSI’s Orbital Atherectomy Systems. ViperSlide increases the lubricity, therefore reducing friction between the device and the ViperWire Advance Coronary Guide Wire.

ARM YOURSELF WITH THE ONLY DEVICE INDICATED FOR SEVERE CORONARY CALCIUM.