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The Diamondback 360 and Stealth 360 orbital atherectomy systems are innovative solutions to address the challenges with treating calcium in your coronary and peripheral interventions.

Challenge with Calcium

Calcium buildup in the vessels can limit blood flow in coronary and peripheral vessels — but treating it isn’t straightforward.
Complex Coronary Arterial Disease (CAD)

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  • Calcific lesions can be difficult to identify on angiography1
  • Of patients undergoing PCI procedures, there is a 6% to 20% risk of severe coronary calcification2,3
  • Calcium inhibits stent placement, full stent expansion, and wall apposition, leading to poor clinical outcomes (higher MACE, TLR)4-6
Complex Peripheral Arterial Disease (PAD)

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  • Calcium buildup in the vessels of PAD patients can reduce procedural short and long term success
    • Decreased ballon success and increased risk of flow limiting dissections7
    • Increased risk of vessel recoil8
    • Decreased success with drug-coated balloons9
How can treatment options be improved?

PROBLEMS

  • Issues with dilation and stent expansion
  • Uneven drug distribution and risk of restenosis
  • Potential for longer treatment time and hospital stay — meaning more resources and higher costs10

GOALS

  • Improving procedural success and long-term clinical outcomes
  • Reducing restenosis and TLR
  • Optimizing stent delivery, expansion, and distribution

About CSI

We are passionately focused on improving outcomes for PAD and CAD, how do we do it?

Elevate

The conversation around what's possible.

Rethink

Revascularization by helping physicians and practices treat patients on their journeys to an improved quality of life.

Develop and commercialize

Innovative solutions for treating PAD and CAD.

Help

Physicians fight calcium, given the complications it presents for the millions who suffer from PAD and CAD.

Deliver

More versatile and specialized solutions that allow for more effective and efficient revascularization.

CSI by the numbers11
EVERY
~6 MINUTES
A patient is treated with a CSI device

850+

Mission-driven employees

230+

Patents

4,600+

Physicians certified globally
~120,000 CAD AND ~570,000 PAD
Devices used to treat patients globally

The CSI Solution

CSI has the only atherectomy system with a diamond-coated crown that orbits 360-degrees, specifically designed to target calcium and treat the entire vessel wall.

HOW IT WORKS

Orbital Atherectomy combines differential sanding and pulsatile forces to remove calcium and improve vessel compliance.
Bi-directional Sanding of Superficial Calcium11,12,16,17
  • Healthy elastic tissue flexes away from the crown, minimizing damage to the vessel with average particulate size = 2μm
Pulsatile Forces11,13,14,16
  • Crown is mounted eccentrically
  • Rotation of the crown over the wire produces high frequencies or vibrations that expand into the vessel tissue
  • These pulsatile forces plus differential sanding affect deeper plaque and fracture calcium

The Dual-Action Advantage

Sanding surface lesions and modifying deep calcium both matter.

Coronary Atherectomy Solution

For optimal vessel prep, only Diamondback 360 Orbital Atherectomy System has a dual-action technology that sands intimal and fractures medial calcium simultaneously11,16 to treat severely calcified lesions.

Accessories

ViperWire Advance Coronary Guide Wire*

Designed to be used with Diamondback 360 to facilitate delivery of the crown to the lesion site.

*Availability varies by country. Please contact your CSI representative regarding the products and features available in your geography.

ViperWire Advance Coronary Guide Wire
with Flex Tip**

Shapeable floppy tip and flexible nitinol body for navigation in complex anatomy.

**Availability varies by country. Please contact your CSI representative regarding the products and features available in your geography.

ViperSlide Lubricant

More lubricity means less friction between the device and the guidewire.

Explore the Evidence

Sustained clinical performance

3.4%11

TLR at 1 year with drug-eluting stents (DES) as observed in the ORBIT II trial

6.6%11

TLR at 3 years with drug-eluting stents (DES) as observed in the ORBIT II trial
ORBIT II was a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions who underwent PCI procedures

LOW RATES OF PROCEDURAL COMPLICATIONS

Low rates of perforation, dissections, and slow flow/reflow as demonstrated in the US pivotal trial with new Diamondback atherectomy operators and real-world registries with experienced operators.15,18,19

Study Details

ORBIT II Pivotal Trial: Prospective, multi-centered, core lab adjudicated U.S. trial. 443 patients in 49 US sites Met primary safety and efficacy endpoints in challenging, heavily stenosed lesions (84.4%: 0.5mm min lumen diameter).15

ORBIT II: Prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions who underwent OA to facilitate stent deployment.15
LEE: Retrospective, real-world, multicenter registry of 458 consecutive patients with severely calcified coronary lesions who underwent OA followed by stenting.18
BEOHAR: Retrospective, observational, single-center study of 519 patients with severely calcified coronary lesions who underwent lesion preparation with OA before stent deployment.19

CASE EXAMPLE

The patient: A 62 year-old male. Former smoker and diabetic with renal insufficiency and hyperlipidemia.

OAS Treatment Details

  • Lesion location: Mid-circumflex (severely calcified)
  • Access site: Radial
  • # of passes (L/H): 3L
  • # of seconds (L/H): 85L
  • Balloon Pressure (ATM): 6

Peripheral Atherectomy Solutions

Stealth 360 is the only atherectomy system with a diamond-coated crown that orbits 360 degrees, specifically designed to target calcium and treat the entire vessel wall.

Crowns

Classic Crown

The most flexible: designed for vessel bends, ostial lesions and distal below-the-knee procedures.

Sizes: 1.50 and 2.00 mm

Solid Crown

Larger mass for greater sanding and shortest run times

Sizes: 1.25, 1.50 and 2.00 mm

Micro Crown

Maximizes flexibility: best for tortuous vessels and tight bends below-the-knee.

Size: 1.25

Accessories

ViperWire Advance Peripheral Guide Wire

Designed to be used with Stealth 360 to facilitate delivery of the crown to the lesion site.

0.014″ with stainless steel core and support coil

ViperWire Advance Peripheral Guide Wire with Flex Tip

Designed to be used with Stealth 360 to facilitate delivery of the crown to the lesion site.

0.014″ with stainless steel core and nitinol support coil

ViperSlide Lubricant

Increases lubricity to decrease friction between the device and the Guidewire.

CALCIUM 360*

Mean Max Balloon Inflation Pressure (atm) p=0.001

COMPLIANCE 360**

Mean Max Balloon Inflation Pressure (atm) p=0.001

EXPLORE THE EVIDENCE

Procedural Benefits in Changing Vessel Compliance in ATK and BTK21,22

*CALCIUM 360 Study: Prospective, multi-center, clinical trial that randomized 50 patients with calcified peripheral BTK lesions 1:1 to orbital atherectomy with PTA or PTA only.22
**COMPLIANCE 360 Study: Prospective, multi-center, clinical trial that randomized 50 patients with calcified peripheral ATK lesions 1:1 to orbital atherectomy with PTA or PTA only.21

 

SUSTAINED CLINICAL PERFORMANCE

Even in the most complex lesions, orbital atherectomy provides a high freedom from TLR / TVR and major amputation at 1 year

FREEDOM FROM TVR/TLR AT 1 YEAR11,23

87%

RC 2-3

79%

RC 4-5

78%

RC 6

LIBERTY 360: prospective, observational, multi-center study in patients with symptomatic lower-extremity PAD undergoing peripheral vascular interventions. 503 patients were part of the orbital atherectomy subset.

CASE EXAMPLE

The patient: An 85-year-old female with claudication. 

OAS Treatment Details

  • # of passes (L/M/H): 1L/1M/2H
  • Balloon Pressure (ATM): 8
  • Waist in balloon (Y/N): No
References
1. Mintz, GS et al. Circulation. 1995;91(7):1959-1965.
2. Genereux P, et al. J Am Coll Cardiol. 2014;63(18):1845-54.
3. Bourantas CV, et al. Heart. 2014;100(15):1158-64.
4. Madhavan M, et al. J Am Coll Cardiol. 2014;63(17):1703-1714.
5. Gudmundsdottir I, et al. Open Heart. 2015;2(1):e000225.
6. Kawaguchi R, et al. Cardiovasc Revasc Med. 2008;9(1):2-8.
7. Fitzgerald PJ, et al. Circulation. 1992;86(1):64-70.
8. Cioppa A, el al. Cardiovasc Revasc Med. 2012;13(4):219-223.
9. Fanelli F, et al. Cardiovasc Intervent Radiol. 2014 ;37(4):898-907.
10. Pietzsch J, et al. Cardiovasc Interv Ther. 2018;33(4):328-336.
11. CSI Data on File
12. Adams G, et al. J Cardiovasc Transl Res. 2011;4(2):220-229.
13. Zheng Y, et al. Med Eng Phys. 2016;38(7):639-647.
14. Saab F, et al. J Cardiovasc Surg.(Torino). 2019;60(2):212-220.
15. Chambers J, et al. JACC Cardiovasc Interv. 2014;7(5):510-518.
16. Shlofmitz E, et al. Expert Rev Med Devices. 2017;14(11):867-879.
17. Mustapha J, et al. J Crit Limb Ischem. 2021;1(3):E118-E125.
18. Lee MS, et al. J Interv Cardiol. 2016;29(4):357–62.
19. Vinardell J, et al. J Am Coll Cardiol. 2020.76(17 Suppl S):B71.
20. Lee MS, et al. Coronary Orbital Atherectomy. 2018. P. Lanzer (ed.), Textbook of Catheter-Based Cardiovascular Interventions, https://doi.org/10.1007/978-3-319-55994-0_42.
21. Dattilo R, et al. J Invasive Cardiol 2014;26(8):355-60.
22. Shammas NW, et al. J Endovasc Ther. 2012;19(4):480-488.
23. Giannopoulos S, et al. J Endovasc Ther. 2020;27(5):714-725.
This webpage is intended for health care professionals & distributors in countries outside of the U.S. where CSI products are authorized for commercial use, except those practicing in France as this webpage is not in compliance with French Medical device advertising requirements in Law No. 2011-2012 of 29 December 2011, Article 34. If you are in the U.S., click here. If you are outside of the U.S., the approval status and labelling of CSI product may vary. Please contact medicalaffairs@csi360.com for additional information about the availability of these products outside of the U.S. Indications for European Union, Canada, Australia and New Zealand: The Diamondback 360 Coronary Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated 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. The Stealth 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and are acceptable candidates for percutaneous transluminal atherectomy. Indications Outside of aforementioned Countries: The Diamondback 360 Coronary Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated 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. The Stealth 360 Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. CSI, Diamondback 360, Stealth 360, ViperWire, ViperWire Advance, ViperSlide and GlideAssist are trademarks belonging to Cardiovascular Systems, Inc. All other trademarks cited herein are owned by their respective owners. ©2022 Cardiovascular Systems, Inc.