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Diamondback 360™

Coronary Orbital Atherectomy System

Severe Calcium.
One Solution.

Diamondback 360 Coronary Orbital Atherectomy System
Clinical Evidence

Orbital Atherectomy is a First-line Approach for Optimal Vessel Prep in Complex PCI Cases with Severe 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.1,2 Moderate to severe arterial calcium is present in 30-40% of patients who undergo a PCI.2,3

 

Challenges Associated with Calcium4

  • Prone to dissection during balloon angioplasty or pre-dilatation
  • Difficult to fully dilate the balloon
  • May prevent stent delivery
  • May prevent adequate stent expansion and apposition
     

Diamondback 360™ OAS has been proven effective and safe in the treatment of severely calcified lesions, studied on over 2,200 patients across 11 robust studies.5,6

 

ORBIT II Clinical Study7

The ORBIT II pivotal trial was a prospective, multi-center study conducted in the U.S. that evaluated patients with severely calcified coronary lesions treated with Diamondback 360™ Coronary Orbital Atherectomy System (OAS) Classic Crown prior to stent implantation.


Key Takeaways

  • ORBIT II met the primary safety and efficacy endpoints by a significant margin7
  • ORBIT II demonstrated long term durable results with a low target lesion revascularization (TLR) rate of 3.4% at 1-year and 6.6% at 3-years in the drug-eluting stent subsets (N=389/443)8
     

Study Design7

  • 443 patients with severely calcified lesions were enrolled at 49 U.S. Sites
  • Designed to evaluate the safety and efficacy of the Diamondback 360™ Coronary OAS Classic Crown
  • Primary Safety Endpoint: Major adverse cardiac events (MACE) at 30 days
  • Primary Efficacy Endpoint: Procedural Success defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE

PATIENT POPULATION7

 N=443
History of Diabetes36.1%
History of CABG14.7%
History of Dyslipidemia91.9%
History of Hypertension91.6%
Smoker (current or previous)66.1%

 

STUDY RESULT7

Procedural Success88.9%
Successful Stent Delivery97.7%
Less than 50% Residual Stenosis98.6%
Freedom from in-hospital MACE90.2%

 

*Procedural success defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an. in-hospital MACE.

30-Day Outcomes9

Diamondback 360 OAS 30 Day Outcomes

1-Year Outcomes9

Diamondback 360 OAS 1-Year Outcomes

References

  1. Mintz GS. Intravascular imaging of coronary calcification and its clinical implications. JACC Cardiovasc Imaging. 2015;8(4):461-471.
  2. Mintz GS, et al. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995;91(7):1959-1965.
  3. Genereux P, et al. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014;63(18):1845-1854.
  4. Shlofmitz E, et al. Orbital atherectomy for the treatment of severely calcified coronary lesions: evidence, technique, and best practices. Expert Rev Med Devices. 2017;14(11):867-879.
  5. Shlofmitz, E., et al., Lesion Preparation with Orbital Atherectomy. Interv Cardiol. 2019;14(3):169-173. .
  6. Beohar, N., Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Lesions. A Tertiary Center Experience, Presented at TCT Connect 2020.
  7. Chambers JW, et al. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv. 2014;7(5):510-518.
  8. Data on file at Abbott.
  9. Lee M, et al. Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial. Cardiovasc Revasc Med. 2017;18(4):261-264.

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