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Diamondback 360™

Coronary Orbital Atherectomy System

Severe Calcium.
One Solution.

Diamondback 360 product
Features

Diamondback 360™ is the only atherectomy system with a diamond-coated crown that orbits 360 degrees, specifically designed to target severe calcium.

Diamondback 360™ Coronary Orbital Atherectomy System’s (OAS) unique dual mechanism of action uses differential sanding and pulsatile forces that enable simultaneous modification of both intimal and medial calcium for optimal stent delivery, expansion, and apposition in severely calcified lesions. One device treats eccentric, concentric, and nodular calcium.1-6

Diamondback 360™ OAS has a Unique Dual Mechanism of Action Design

One device reduces intimal calcium and fractures medial calcium. Differential sanding and pulsatile forces enable simultaneous modification of both intimal and medial calcium for optimal stent delivery, expansion, and apposition in severely calcified lesions.1-4
 

OCT Imaging

Diamondback 360™ OAS Gives You the Versatility to Treat Challenging Cases

Treat even the most severely calcified lesions, with under 2-minute setup7,8 and predictable procedure times.2
 

Facilitates antegrade and retrograde treatment of:

  • Long, Diffuse Lesions
    Successfully treated lesions up to 60 mm in length in real-world study.9
  • Heavily Stenosed Lesions
    Crossed >99% of lesions with <2% pre-dilatation in the ORBIT II study.1,10
  • Nodular Lesions
    Effectively treats nodular calcification.5,6
  • Ostial Lesions
    Safely treats ostial lesions.11
     

Low Profile

6F compatible for femoral or radial access.12
 

Multiple Vessel Sizes

A single 1.25 mm crown treats vessels 2.5 mm to 4.0mm12
 


Diamondback 360™ OAS Has Been Proven Effective and Safe in the Treatment of Severely Calcified Lesions.

Extensively studied, and with over 100,000 patients treated,13 orbital atherectomy has been demonstrated to perform effectively and safely in the treatment of severely calcified lesions.
 

 

>2,200

Patients Across 11 Robust Studies5,9

Proven Safety

<1%

Component Angiographic Complications in Two Real-world Studies9,14

Procedural Success

97.7%

Crossing and Stent Deployment in ORBIT II Study1

Low Q-Wave MI Rate

0.9%

In the ORBIT II Study at 30 days1

ORBIT II Target Lesions Revascularization (TLR)15


Sustained Clinical Performance

Data are for ORBIT II TLR in the OA+DES patient cohort.

3.4%
at 1 Year

5.1%
at 2 Years

6.6%
at 3 Years

The ORBIT II trial included patients with severely calcified lesions and demonstrated low rates of TLR at 1, 2, and 3 years.


References

  1. Chambers, J., et al., JACC Cardiovasc Interv. 2014;7(5):510-518.
  2. Shlofmitz, E., et al., Expert Rev Med Devices. 2017;14(11):867-879.
  3. Yamamoto, M., et al., Catheter Cardiovasc Interv. 2019;93(7):1211-1218.
  4. Kini, A., et al., Catheter Cardiovasc Interv. 2015;86(6):1024-1032.
  5. Shlofmitz, E., et al., Interv Cardiol. 2019;14(3):169-173.
  6. Abellas-Sequeiros, M., et al., REC Interv Cardiol. 2022;4(2):163-164.
  7. Lee, MS, et al., J Invasive Cardiol. 2016;28(4):147-150.
  8. Moses, J., Cardiac Interventions Today. 2015;May/June:75. Link accessed November 20, 2023. https://citoday.com/articles/2015-may-june/vesselpreparation- with-orbital-atherectomy-for-treating-severe-coronary-calcium-for-stent-delivery.
  9. Beohar, N., Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Lesions. A Tertiary Center Experience, Presented at TCT Connect 2020.
  10. Data on file at Abbott (CLN-0001-R.D_ORBIT II Clinical Report). In the ORBIT II study, the OAS was inserted and activated in 434 subjects, but in 2 cases, the OAS was unable to cross the lesion.
  11. Lee, et al., J Interv Cardiol. 2018;31(1):15-20.
  12. Diamondback 360™ Coronary Orbital Atherectomy Systems Instructions for Use (IFU). Please refer to IFU for additional information.
  13. Data on file at Abbott.
  14. Lee, MS, et al., J Interv Cardiol. 2016;29(4):357-362.
  15. Data on file at Abbott (CLN-0001-R.D supplement: Kaplan-Meier Tables 3-year data-stent type 05Feb16).

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