Hospital Administration



Improve patient outcomes and reduce healthcare costs





As a hospital administrator, you often face difficult and demanding challenges every day. You need to prepare for the demands of an aging population. You must improve patient care by recruiting the most talented staff and you must acquire the most efficient, effective technology.

Plus, you have to navigate the uncertainty of healthcare reform, including Medicare and Medicaid reimbursements and the transition from fee-for-service to alternative payment models (APMs). All while streamlining costs and maintaining fiscal responsibility. At CSI, we are committed to offering technology that helps improve patient outcomes and delivers value.


Patient Stories

Helping you get your patients back to what matters


Treat Peripheral Artery Disease

Orbital atherectomy can be a critical element in a revascularization-first strategy. Amputation is among the costliest treatment options.36,37 The cost for an advanced PAD patient, one with critical limb ischemia (CLI), following a lower extremity amputation is $49,000 annually.12

Revascularization procedures result in demonstrated improvements in patient outcomes and reduced costs when compared to amputation.13,14,37 It’s estimated that a 25% reduction of amputations could save $2.9 billion to $3 billion in healthcare expenditures in the US13,14

$212billion

to

$389billion

annual PAD direct costs*14-19


*Includes inpatient and outpatient costs, including all-cause hospitalizations, medications and other costs for PAD patients in the US REACH population in 2015 ($10,881 x 19.5 million people with PAD) and managed care population in 2014 ($19,963 x 19.5 million people with PAD). Range calculated by The SAGE Group, 2015.
>1million

physician office visits with a primary diagnosis of PAD in 201238


19thousand

emergency department visits for PAD in 201138


291thousand

outpatient department visits for PAD in 201138

Treat Severely Calcified Coronary Lesions

The annual burden of illness due to coronary artery calcification is estimated at between $1 billion and $3 billion.18 The burden for all heart diseases will escalate in the future, according to the American Heart Association (AHA). The AHA estimates that by 2030, 40.5% of the US population will have some form of cardiovascular disease, costing an estimated US $818 billion.4

Patients with severe calcification present a greater risk of complication rates, which increases overall hospitalization costs.4,19 Orbital atherectomy can be a critical tool for severely calcified lesions to enable successful stent deployment with low complication rates.4

OAS savings compared to percutaneous coronary intervention (PCI) standard of care, according to CSI ORBIT II study7
Example only based on United States national estimates. Actual reimbursement rates may vary. Estimated Medicare national average overhead. ORBIT II cost-effectiveness study7 with Extrapolation of 1-year economic data to 2-year estimates by Brad J. Martinsen, Ph.D. (CSI). Regression analysis with a Power line fit to give predicted 730-day cost offset/savings. Podium Presentation at EuroPCR 2015, Paris and Data on file at CSI. Medicare comparison sample was drawn from the 100% Standard Analytical File for reported period. The base case analysis was restricted to calcification patients from hospitals (N=17) reporting more the 10% of stent patients with calcification during this initial period. PCI patients with severely calcified lesions with acute coronary syndrome. Study design and enrollment criteria differ from ORBIT II.

Commitment to Clinical & Economic Rigor


Physicians and payers are increasingly seeking clinical and economic evidence to allow them to make decisions regarding optimal treatment of patients. We are focused on conducting and collecting clinical and economic evidence to demonstrate the advantages of OAS in treating complex disease states such as PAD and CAD.

We believe that the clinical data and cost-effectiveness of our OAS technology will help drive physician utilization of the OAS and sustain ongoing reimbursement coverage for our devices.11



Clinical Evidence

  • Liberty360
    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
    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 Clinical Study
    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
    anemptytextlline
    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-360-Series
    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-360
    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 Clinical Study
    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)
  • Compliance360
    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)


We believe true innovation is a product of tireless investigation

*Includes PAD and CAD clinical evidence
7000+
Lesions*

600+
Physicians*
5000+
Patients*

250+
Hospitals*

Upcoming Conferences

Events Calendar

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Wed 22

ARCH

April 22 - April 25
Fri 24

OEIS

April 24 - April 26
Thu 07

CRF Fellows

May 7 - May 10
Wed 13

SCAI

May 13 - May 16
Tue 19

Euro PCR

May 19 - May 22

For more information about these upcoming conferences, talk to your CSI representative.

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