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Leave the
RIGHT thing behind™

We are committed to reducing the number of preventable amputations, thereby reducing the significant morbidity, mortality, and burden of Critical Limb-Threatening Ischemia (CLTI) disease in people living with Peripheral Arterial Disease (PAD).

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>250 million people worldwide with PAD by 20301
>21 million people in the U.S. with PAD2
2.0–3.4 million people in the US with CLTI3
150K amputations per year in the US, 44–85% diabetes related may be preventable4

Against the impact of CLTI

CLTI is associated with poor quality of life and high treatment costs5,6,7

Poor quality of life associated with CLTI amputations and non-healing wounds with suboptimal, highly invasive, expensive treatment options.

Significant morbidity, with CLTI mortality rates exceeding those for every other form of occlusive cardiovascular disease.

Spiraling economic burden on all levels of the healthcare system.

The System

Designed specifically for below-the-knee interventions

The technology has the ability to maintain flexibility yet resist being crushed in this challenging anatomy.

01 Reliable

Low profile delivery system allows for access from above or below.

02 Consistent

Purposeful design ensures consistent clinical applicability.

03 Predictable

Broad sizing matrix allows for utilization in all the target vessels below-the-knee.

Major Amputations

The most vulnerable are at risk

Approximately 200,000 lower limb amputations performed in the United States each year are due to CLTI. In the United States, 25% of those with CLTI require an amputation within one year after the CLTI diagnosis.8

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References:

  1. Conte MS, Bradbury AW, Kolh P, et al. Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019;58(1 Suppl):S1-S109.e33. doi:10.1016/j.ejvs.2019.05.006. Published simultaneously in J Vasc Surg. 2019.
  2. https://hmpgloballearningnetwork.com/site/vdm/current-us-prevalence-peripheral-arterial-disease
  3. https://rehabpub.com/conditions/amputation/sage-group-analysis-estimates-prevalence-cli/
  4. https://www.cdc.gov/mmwr/preview/mmwrhtml/00015500.htm
  5. Mary Yost Presentation – NCVH 2026- the yost group, gornik HL. circulation. 2024;149:e00-e00 and strong MB. Br J. Surg. August 1;112(8):znaf150.
  6. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease. Circulation. 2024;149(24):e1313-e1410. https://evtoday.com/articles/2024-sept/panel-discussion-the-2024-pad-guideline-update-how-it-affects-practice
  7. International BEST-CLI Collaborative: next steps to create a coordinated global initiative to improve awareness and access while reducing mortality and amputation for patients with chronic limb-threatening ischaemia. Br J Surg. 2025;112(8):znaf150. https://pubmed.ncbi.nlm.nih.gov/40794623/
  8. Ratliff C, Rovnyak V. Retrospective descriptive study of individuals with chronic limb-threatening ischemia (CLTI) admitted to the academic vascular surgery unit for a major lower limb amputation. Journal of Vascular Nursing. 2025;43(4):210-215. ISSN 1062-0303. doi:10.1016/j.jvn.2025.08.005.