Value-Based Evidence

The Diamondback 360^® Peripheral Orbital Atherectomy System, in combination with percutaneous angioplasty (PTA), have been shown to offer more favorable short-term and long-term patient outcomes in PAD treatment when compared head-to-head with balloon angioplasty alone:⁵

• Lower percentage of patients requiring revascularization 6 – 12 months after the procedure^5,6
• Lower rate of dissections^5,6
• Reduced need for adjunctive/bail-out stenting^5,6
• Higher percentage of patients achieving ≤30% final residual stenosis⁵

An incremental cost analysis of OAS in the treatment of PAD¹¹:

• 1-year incremental cost of $549 compared to balloon angioplasty (BA)
• Incremental cost-effectiveness ratio (ICER) of $3,441
• ICER result well below the $50,000 threshold generally considered cost effective in the US
• Cost to treat restenosis: $13,734 for OAS + BA vs. $20,609 for BA alone
• Costs for a reintervention procedure is higher in the BA group by $7,000

The annual burden of illness due to coronary artery disease is estimated at between $1 billion and $3 billion.¹⁸ Patients with severe calcification present a greater risk of complication rates, which increases hospitalization costs.^4,19

Diamondback 360^® Coronary Orbital Atherectomy System (OAS) reduces severe calcium, enabling successful stent delivery to help optimize stent expansion and PCI outcomes.

The coronary OAS is the first novel technology to receive FDA approval to specifically treat severely calcified lesions.⁴ The Diamondback 360^® Coronary OAS has a unique mechanism of action designed to:

• Treat 360˚of the vessel
• Provide continuous flow of blood and saline during orbit, minimizing thermal injury

PCI Procedure Costs¹⁹

An Incremental Cost Analysis of OAS in the Treatment of CAD Found:

• Savings could be as high as $1,118 (compared to the PCI standard of care minus the cost of the device)⁷
• Average patient gaining 0.247 life-years⁷
• $11,895 per life-year gained as a calculated ICER⁷

Results calculated based on modeled synthesis of clinical and economic data utilizing the cost of using the OAS technology in elderly (>65 years) Medicare patients with de novo severely calcified lesions compared to cost offsets. Clinical data from the ORBIT II trial using the pooled analysis of the HORIZONS-AMI and ACUITY trials for comparison. Index procedure costs from Medicare data.

Disclaimer

Example only based on national estimates. Actual reimbursement rates may vary. *Estimated Medicare national average overhead.

Please note: Reimbursement information provided by CSI is gathered from 3rd party sources and is presented for illustrative purposes only. This information does not constitute legal or reimbursement advice.

CSI makes no representation or warranty regarding this information or its completeness, accuracy, timeliness or applicability with any particular patient. CSI specifically disclaims liability or responsibility for the results or consequences of any actions taken in reliance on information in this document. CSI encourages providers to submit accurate and appropriate claims for services. Laws, regulations and payer policies concerning reimbursement are complex and change frequently.

Providers are responsible for making appropriate decisions related to coding and reimbursement submissions. Accordingly, CSI recommends that customers consult with their payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters.