The Challenge of Calcium

Calcium is one of the biggest challenges you face with today’s complex patients. It’s good to know that for severely calcified lesions, and whatever type of calcified lesion you’re treating, orbital atherectomy is the single solution you need to get from calcified to compliant, safely and efficiently.

 

 

 

See the Unique Dual-Action Technology of Diamondback®

ONLY ORBITAL ATHERECTOMY FOR CORONARY BRINGS IT ALL TOGETHER

DUAL-ACTION MOA

CORONARY

Uniquely designed for calcium: Enables 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.15-19


Combines differential sanding and pulsatile forces to safely, effectively and efficiently treat severely calcified lesions.15,16,20

VERSATILE

CORONARY
Patients with percutaneous coronary intervention (PCI) procedures can be challenging. Orbital atherectomy gives you the versatility to treat those challenging cases, including the most severely calcified lesions, with under 2-minute set up and predictable procedure times.20

  • OSTIAL LESIONS

    Safely treats ostial lesions.21


  • HEAVILY STENOSED

    Crossed >99% of lesions with <2% pre-dilatation in the ORBIT II study.15,22


  • LONG, DIFFUSE LESIONS

    Successfully treated lesions up to 60 mm in length in real-world study.23


  • LOW PROFILE

    6 Fr compatible.


  • MULTIPLE VESSEL SIZES

    Treats a range of vessels enabling single device treatment of multiple lesions and vessel sizes.

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PROVEN

CORONARY

Extensively studied, and with over 85,000 patients treated, orbital atherectomy has been demonstrated to perform effectively and safely in the treatment of severely calcified lesions.

EXTENSIVELY STUDIED

>2,200

PATIENTS ACROSS 11 ROBUST STUDIES19,23

PROVEN
SAFETY

<1%

COMPONENT ANGIOGRAPHIC COMPLICATIONS IN 2 REAL-WORLD STUDIES23,24

PROCEDURAL SUCCESS

100%

CROSSING AND STENT DEPLOYMENT IN REAL-WORLD STUDY23

LOW Q-WAVE
MI RATE

0.9%

IN THE ORBIT II STUDY AT 30 DAYS15

ONLY ORBITAL ATHERECTOMY FOR PERIPHERAL BRINGS IT ALL TOGETHER

DUAL-ACTION MOA

PERIPHERAL

Uniquely designed to enable simultaneous modification of both intimal and medial calcium.

VERSATILE

PERIPHERAL

The low-profile design of our orbital atherectomy systems and unique extended length option can help you improve your procedural range and patient satisfaction.

IMPROVED CLINICAL EXPERIENCE

  • Low profile systems can reduce access site complications7 and allow for non-femoral access options, like transpedal
  • Transradial procedures with orbital atherectomy have a high rate of procedural and treatment success, as demonstrated in the REACH PVI study8

BETTER PATIENT EXPERIENCE

Alternative access procedures can:

  • Allow for a more comfortable recovery
  • Provide for a shorter length of stay9
  • Improve the patient experience10

PROVEN

PERIPHERAL

Orbital atherectomy is proven to be effective with a full range of calcified lesions, above- and below-the-knee, and across a wide range of Rutherford Classes (RC 2-6).11

Long-Term Durability

4,800

PATIENTS STUDIED12

90%

PRIMARY PATENCY AT 2 YEARS IN RC 2-313

95%

FREEDOM FROM MAYJOR AMPUTATION AT 3 YEARS, RC 4-511

89%

FREEDOM FROM AMPUTATION AT 3 YEARS, RC 611

Real-world Case Studies using Diamondback 360

Education Highlights

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PEER-TO-PEER TRAINING

Preceptor/Proctorships

Nurse/Technologist
Programs

Regional & National
Courses

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SPECIALIZED PATHWAYS

Intermediate: An
Introduction to Therapy Technology.
Taught by Certified Instructors

Advanced: Expanding Skills and Techniques. Best Practices

Masters: Leading Experts.
Clinical Updates. Latest
Techniques

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FELLOWS EDUCATION

OAS Certification

Fellows Course &
Milestones Calendar

Online Learning Modules
& Focused Webinars

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VIRTUAL
EDUCATION

OAS Certification

Case Library

CSIQ Learning Management
System

Peer-to-Peer Webinars

Live Case Broadcasts

​For more information on CSI’s Professional Education Program, click here:

Stay In Touch

Join our email list to get updates about our commitment to constant progress. You’ll see how CSI and orbital-first users are shaping the future of peripheral and coronary procedures.

  1. Shammas NW, Lam R, Mustapha J, Ellichman J, et al. Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther. 2012 Aug;19(4):480-8
  2. Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005 Jan 18;45(2):312-5.
  3. Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. Circulation. 1992; 86(1):64-70.
  4. Adams GL, Khanna PK, Staniloae CS, et al. Optimal techniques with the Diamondback 360° System achieve effective results for the treatment of peripheral arterial disease. J Cardiovasc Transl Res. 2011 Apr;4(2):220-9.
  5. Krishnan P, Martinsen BJ, Tarricone A, et al. Minimal Medial Injury After Orbital Atherectomy. J Endovasc Ther. 2017 Feb;24(1):167-168.
  6. Zheng Y, Belmont B, Shih AJ. Experimental investigation of the abrasive crown dynamics in orbital atherectomy. Med Eng Phys. 2016 Jul;38(7):639-647.
  7. Bosiers M, Deloose K, Callaert J, et al. 4-French-compatible endovascular material is safe and effective in the treatment of femoropopliteal occlusive disease: results of the 4-EVER trial. J Endovasc Ther. 2013 Dec;20(6):746-56.
  8. Lodha A. REACH PVI Clinical Study Results. Presented at NCVH 2020.
  9. Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, et al. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9.
  10. Thakor AS, Alshammari MT, Liu DM, et al. Transradial Access for Interventional Radiology: Single-Centre Procedural and Clinical Outcome Analysis. Can Assoc Radiol J. 2017 Aug;68(3):318-327.
  11. Giannopoulos S, Secemsky EA, Mustapha JA, et al. Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia. J Endovasc Ther. 2020 Oct;27(5):714-725.
  12. CSI Data on File
  13. Adams GL, et al. J Vasc Surg. 2019;70(5):e188-e189.
  14. Dattilo R, Himmelstein SI, Cuff RF. The COMPLIANCE 360° Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol. 2014;26(8):355-60.
  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. Yamamoto M, et al. Catheter Cardiovasc Interv. 2019;93(7):1211-1218.
  18. Kini A, et al. Catheter Cardiovasc Interv. 2015;86(6):1024-1032.
  19. Shlofmitz E, et al. Interv Cardiol. 2019;14(3):169-173.
  20. CSI Data on File.
  21. Lee, et al. J Interven Cardiol. 2018;31:15-20.
  22. CSI Data on file. 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.
  23. Vinardell, TCT2020, No. 165.
  24. Lee M, et al. Cardiovasc Revasc Med. 2017 Jun;18(4):261-264.
  25. 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. Note: These data are from different studies that differ in terms of treatment protocols, inclusion/exclusion criteria, patient populations, among other things. Physicians should draw their own conclusions based on the findings in the respective publications.