United States – Critical Limb Ischemia by Rutherford Category Prevalence and Markets in Patients and Limbs 2017

This report contains a comprehensive analysis of the U.S. prevalence of critical limb ischemia (CLI) by Rutherford Category: Rutherford 4-rest pain, Rutherford 5-ulcers and Rutherford 6-gangrene. Prevalence is defined as the number of new and old cases of CLI.

Estimates by Rutherford Category begin with the total prevalence of CLI (R4-R6) for a high and low set of CLI estimates. The high and low CLI estimates are projected for the 2015-2030 periods. These CLI estimates were recently published in the revised analysis of peripheral artery disease and critical limb ischemia titled “Critical Limb Ischemia Volume I Unites States Epidemiology 2016 Supplement”.

Recently published data on the percentage prevalence of CLI patients by Rutherford Category is employed to estimate the number of patients in each Rutherford category (R4-R6) for 2015-2030.

Within each Rutherford Category, patients are assumed to be treated with revascularization, amputation or palliative therapies. Prevalence by treatment pathway is projected for each Rutherford Category for 2015-2030. The percentage assigned to each treatment pathway is based on recent data.

Prevalence represents the potential market assuming all CLI patients are diagnosed and treated. However, according to our research, only a fraction of patients are diagnosed and treated. For each Rutherford category, the current market, or those diagnosed and treated, is estimated by treatment pathway for 2015-2030.

Since CLI is commonly bilateral, all Rutherford Category estimates are made for limbs as well as for patients. The percentage estimated to be afflicted with bilateral disease is based on data in the peer-reviewed literature.

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