Orbital: Primary treatment for arterial calcium

At Cardiovascular Systems, Inc.. (CSI), we have partnered with the top minds in the field to pioneer innovative solutions for the treatment of peripheral and coronary vascular disease. The presence of arterial calcium is indicative of both advanced CAD and PAD and can be difficult to treat.

We understand the challenges that physicians face when treating severely calcified arterial lesions, and our primary focus is helping you conquer even the most difficult cases.

Physicians and their teams are on the lookout for calcification in their patients with vascular disease.

You can specifically schedule a Calcium Awareness Day for your lab to focus on the patient most at risk.

Patient predictors for coronary calcification15:

  • Diabetes
  • Hypertension
  • Chronic Kidney Disease
  • Smoker
  • Dyslipidemia
  • Advanced Age
  • Prior CABG/PTCA16
  • Known PVD/CAD

Moderate to severe arterial calcium is present in nearly


of patients who undergo a PCI1

Severely calcified lesions have


the MACE rate of other PCI lesions/patients9-11

Calcified lesions are often underestimated and underrepresented by angiography alone1,12

Calcification was seen in


of coronary lesions via angiography1

Calcification was seen in


via IVUS1

Angiography underestimates severe calcium by


in peripheral cases12

Calcium creates a barrier to optimal absorption from drug-eluting balloons

When You See Calcium, Think Diamondback 360®

The Only Device Indicated for Treating Severely Calcified Lesions

The unique mechanism of action (MOA) uses a patented combination of differential sanding and centrifugal force to reduce coronary and peripheral arterial calcium without damaging healthy tissue.

The Diamondback 360® Coronary OAS is the Only Device Indicated for Treating Severely Calcified Lesions in CAD


Arterial calcium can lead to significant PCI-related complications. It is common in patients with kidney disease and/or diabetes. Calcified coronary lesions:

  • Prone to dissection during balloon angioplasty or pre-dilation44
  • Make it difficult to completely dilate a balloon45
  • May prevent adequate stent expansion or apposition46
  • May prevent stent delivery to the desired location47

Despite being a relatively common problem, there have been a limited number of studies that included only patients with severe coronary calcification. Due to poor clinical outcomes, including higher MACE and angiographic complications, patients with severe calcium have been excluded from most large-scale clinical trials, and it has been an exclusion criteria for the majority of bioresorbable vascular scaffold (BVS) trials.

Studies demonstrate OAS is the smart solution for arterial calcium in PAD

Addressing calcium in peripheral artery disease is important for improving outcomes:

  • Angiography underestimates severity of calcification12
  • Technically challenging interventions48-50
    • Decreased balloon success
      • As circumferential calcium increases, the effectiveness of DCB decreases48
      • Vessel recoil in the presence of severe calcium53
    • Decreased stent success
      • Presence of calcium is predictor of stent fracture54
      • 41% of patency at 12 months with a stent fracture55
  • Associated with a higher procedural complication rate that may be a predictor of long-term durability44,51
    • Higher frequency of dissections
      • 74% of flow-limiting dissections occur in calcium44
      • Dissections significantly larger in calcified vs. non-calcified plaque44
      • Lead to higher bail-out stent placement

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Calcium 360º Study: randomized, multi-center study comparing orbital atherectomy + PTA to PTA alone in calcified lesions below-the-knee (BTK).
MAE: Device- or procedure-related major amputation (above-the-ankle), all-cause mortality and TLR/TVR.

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COMPLIANCE 360º Study: prospective, randomized, multi-center study comparing orbital atherectomy + PTA to PTA alone in calcified lesions above-the-knee (ATK).
Bailout stent: Stent placed due to residual stenosis >30%.

Clinical & Economic Evidence

Clinical studies, economic evidence, and peer-reviewed articles about orbital atherectomy

Patient Stories

We are committed to helping you get your patients back to what matters

Choose the innovative technology that addresses arterial calcium.