Calcium


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

40%

of patients who undergo a PCI1

Severely calcified lesions have

2X

the MACE rate of other PCI lesions/patients9-11



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

Calcification was seen in

38%

of coronary lesions via angiography1

Calcification was seen in

73%

via IVUS1

Angiography underestimates severe calcium by

>50%

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


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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

  • LIBERTY 360º
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    CLICK HERE TO SEE THE LIBERTY 360° STUDY 3-YEAR DATA LIBERTY is the largest, contemporary, real-world experience study to evaluate procedural and long-term clinical outcomes of endovascular device interventions in patients with symptomatic lower extremity peripheral artery disease (PAD). Study Design1   Prospective, observational, multicenter study that includes any FDA-cleared or approved technology to treat claudication and critical limb ischemia (CLI). 1204 patients enrolled at 51 sites and were followed for up to 5 years. 4 core labs used for independent analysis. Key endpoints: Procedural and lesion success, Major Adverse Events (MAEs), Duplex Ultrasound (DUS), Quality of Life (QoL), and Six-Minute Walk Test (6MWT). Key inclusion criteria: Rutherford classification (RC) 2 to 6, target lesion located within or extending into 10 cm above the medial epicondyle to the digital arteries (distal 1/3 of the SFA and below), and at least one lesion that can be treated with an endovascular device.   Conclusion Peripheral vascular intervention (PVI) may be a reasonable treatment option across all Rutherford classes with durable results lasting to 3-years.2 High freedom from major amputation TVR/TLR at 3 years across all Rutherford classes2 In the OAS sub-analysis, freedom from major amputation TVR/TLV rates at 3 years were even higher than in the full patient cohort2 Improved Quality of Life by 30 days and maintained to 3 years across all Rutherford classes High long-term patency rates through 2 years in RC2-33 Improvement in mean number of wounds from 30 days to 2 years in RC4-63   1. Mustapha et al. One-Year Results of the LIBERTY 360 Study. J Endovasc Ther. 2019;26(2):143-154. 2. Mustapha JA. LIBERTY 360 Trial 3-Year Update. Presented at AMP 2019. 3. Mustapha JA. Late Breaking: LIBERTY 360 Trial 2-Year Update. Presented at AMP 2018.
  • ORBIT II
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    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 demonstrated long term durable results with a low target lesion revascularization (TLR) rate of 3.4% at 1 year in the drug-eluting stent (DES) subset (N=389/443) ORBIT II met the primary safety and efficacy endpoints by a significant margin Study Design 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
  • COAST
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    COAST was a prospective, multi-center study conducted in the U.S. and Japan that evaluated patients with severely calcified coronary lesions treated with the Diamondback 360® Coronary Orbital Atherectomy System (OAS) Micro Crown prior to stent implantation. Key Takeaways COAST patients had a low rate of target lesion revascularization (TLR) of 6.3% at one year COAST trial showed that the Diamondback 360® Coronary OAS Micro Crown was safe and effective in treating severely calcified lesions Study Design 100 patients with severely calcified lesions were enrolled at 12 sites in U.S. and 5 in Japan Designed to evaluate the safety and efficacy of the Diamondback 360® Coronary OAS Micro 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
  • ECLIPSE
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    ECLIPSE: Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug Eluting StEnts   Purpose of the ECLIPSE Trial Severely calcified coronary lesions represent 6-20%1,2 of the total Percutaneous Coronary Interventions (PCI) market (880K annual procedures). Coronary atherectomy represents < 5%3,4 of the PCI market and is not currently classified as the Standard of Care (SOC) in treatment guidelines. ECLIPSE is a prospective, randomized one to one (1:1), multi-center trial designed to evaluate vessel preparation with the Diamondback 360® Coronary Orbital Atherectomy System (OAS) Classic Crown compared to conventional balloon angioplasty technique prior to stent implantation for the treatment of severely calcified coronary artery lesions. References: 1. Genereux P, et al. J Am Coll Cardiol. 2014; 63(18): 1845 - 1854. 2. Bourantas CV, et al Heart. 2014; 100(15): 1158-1164. 3. El Hajj M, et al. Cath Lab Digest. 2018;26(6):June 2018. 4. Arora S, et al. Am J Cardiol. 2016;117(4):555-562.   Study Design Approximately 2,000 patients with severely calcified coronary lesions will be enrolled at approximately 150 sites in the U.S. The imaging cohort will consist of approximately 250 subjects per arm with an optical coherence tomography (OCT) assessment of acute minimum stent area (MSA) at the conclusion of the procedure. Co-Primary Endpoints: Acute MSA defined as in-stent minimal cross-sectional area as assessed by OCT at the conclusion of the procedure in the OCT imaging cohort. 1-year target vessel failure (TVF) defined as the composite of cardiac death, target vessel related myocardial infarction, or ischemia-driven target vessel revascularization. Secondary Endpoints: Procedural Success defined as successful stent delivery with final Core Lab defined TIMI flow 3 and angiographic in-stent diameter stenosis [DS] ≤ 20%, and with the absence of any of the following: stent loss, coronary perforation, or intra-procedural death. Strategy success defined by Procedural Success without crossover to alternative treatment.
  • CONFIRM Series
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    A prospective, multi-center series of acute registries (CONFIRM I, II, and III) to evaluate the procedural outcomes of Orbital Atherectomy System (OAS) treatment in real-world patients with infrainguinal Peripheral Artery Disease (PAD). Key Takeaways Low rate of procedural complications Overall 81% moderate to severely calcified infrainguinal lesions Study Design Three consecutive prospective registries conducted under a similar protocol from 2009 to 2011 Real-world patients with no inclusion/exclusion criteria OAS used in accordance with approved indication Three generations of the OAS device evaluated
  • CALCIUM 360º
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    A prospective, randomized, multi-center study that compared the acute and long-term results of Orbital Atherectomy System (OAS) + percutaneous transluminal angioplasty (PTA) versus PTA alone in calcified below-the-knee (BTK) lesions. Key Takeaways Lower mean maximum balloon inflation pressure in OAS+PTA arm Lower rate of major adverse events at 12-months in OAS+PTA arm Study Design 50 Critical Limb Ischemia (CLI) patients enrolled at 8 U.S. sites Patients randomized to either OAS+PTA (25 pts) or PTA alone (25 pts) and followed for 12 months
  • TRUTH
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    A prospective, single-arm, single-center study using intravascular ultrasound (IVUS) to assess Orbital Atherectomy System (OAS)-related plaque modification of femoropopliteal lesions. Key-Takeaways OAS modified the calcified component of the plaque burden (IVUS analysis) Calcium reduction was responsible for 86% of lumen area increase (IVUS analysis) Increase in minimum lumen area post-OAS (IVUS analysis) Low mean maximum balloon inflation pressure post-OAS of 5.2 atm Study Design 25 patients enrolled at a single center Patients treated with OAS+ percutaneous transluminal angioplasty (PTA) and followed for 12 months IVUS images collected pre-OAS, post-OAS, and post-PTA (IVUS Core Lab)
  • COMPLIANCE 360º
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    A prospective, randomized, multi-center study that compared the acute and long-term results of Orbital Atherectomy System (OAS) + percutaneous transluminal angioplasty (PTA) versus PTA alone in calcified above-the-knee (ATK) lesions. Key Takeaways Lower mean maximum balloon inflation pressure in OAS+PTA arm Lower adjunctive stent rate in OAS+PTA arm OAS demonstrated reduced stenting with durable results out to 12 months versus PTA alone Study Design 50 patients enrolled at 9 U.S. sites Patients randomized to either OAS+PTA (25 pts) or PTA alone (25 pts) and followed for 12 months
  • OPTIMIZE - Follow-Up Phase
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    OPTIMIZE is a prospective, randomized one to one (1:1), multi-center European pilot study designed to evaluate Orbital Atherectomy vessel preparation prior to drug coated balloons (DCBs) compared to DCB alone for the treatment of calcified below-the-knee lesions. Study Design Approximately 50 patients will be enrolled at up to 10 European sites and followed for up to 2 years Late lumen loss at 6 months post-procedure will be an outcome measure
  • REACH PVI
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    REACH PVI is a prospective, observational, single-arm, multi-center, post-market clinical study designed to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions. Study Design Approximately 50 subjects will be enrolled at up to ten (10) active sites in the United States (U.S.) The primary outcome is defined as successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access related events Subjects will be followed post-procedure through the first standard of care follow-up visit (7-45 days post procedure)


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Choose the innovative technology that addresses arterial calcium.