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About Chronic Limb-
Threatening Ischemia (CLTI)

A Life With CLTI

Living with Peripheral Artery Disease (PAD) that progresses to CLTI is challenging. Life revolves around chronic leg pain that can become unbearable over time. The end stage of the disease is characterized by non-healing foot ulcers that considerably lessen mobility and quality of life.

Finally, and often after several medical interventions, the result is major amputation of the lower leg to resolve chronic pain and non-healing wounds, or to prevent progression of gangrene and sepsis. Major limb amputation is a drastic, life-changing step, and LimFlow was designed to provide a new option for these patients.

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About Amputation

Every 2 Minutes a Leg is Amputated1,2
(In U.S. and Europe)
About CLTI – U.S.
About CLTI – U.S.
35-45% of Patients Go Straight to Amputation Without CLTI Diagnosis1,3
About CLTI – U.S.

Once Amputated

Die Before Leaving Hospital4
50% of patients with amputation secondary to PAD die in 12-24 months5
20-37% Have Major Complications4
$794,000+ Lifetime Direct Healthcare Costs per Patient6
19+ Hospital Admissions/Year3

CLTI Leads to Poor Quality of Life

About CLTI – U.S.

Quality of Life for No-option CLTI Patients Worse than Other Major Diseases7

About CLTI – U.S.

About CLTI - Quality of Life | amCharts

About CLTI – U.S.
PCS (Physical Composite Score) from the SF-35 Quality of Life Instrument, a common quality of life measurement.

CLTI is a Global Problem

Individuals Suffer from CLTI1,4,8,9
New "No-option" CLTI Patients Diagnosed Each Year10,11
(In U.S., Europe and Japan)

Current CLTI Treatment Outcomes Are Variable

About CLTI – U.S.
1. Reinecke H, Unrath M, Freisinger E, Bunzemeier H, Meyborg M, Lüders F, et al. Peripheral arterial disease and critical limb ischaemia: still poor outcomes and lack of guideline adherence. Eur Heart J. 2015 Apr 14;36(15):932-8.
2. Mustapha J. The relationship between amputation and mortality: It’s time to discuss the obvious. Paper presented at the Visionary Endovascular & Vascular Education Symposium (VERVE), Sydney, Australia. 2016 Dec.
3. Yost M. Cost-benefit analysis of critical limb ischemia in the era of the Affordable Care Act. Endovascular Today. 2014 May.
4. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FGR. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007 Jan;45(1):S5-67.
5. Peters et al. (2019, October 19). Is a Good Quality of Life and Health Status Possible in Older Patients Dying from Critical Limb-Threatening Ischemia: A Prospective Clinical Study. Retrieved from https://www.annalsofvascularsurgery.com/article/S0890-5096(19)30888-X/fulltext

6. Palli SR, Gunnarsson C, Kotlarz H, Martinsen B, Ruizhi Z, Rizzo JA. Impact of a limb salvage program on the economic burden of amputation in the United States. Value Health. 2016 May;19(3):A45.
7. Sprengers RW, Teraa M, Moll FL, de Wit GA, van der Graaf Y, Verhaar MC, et al. Quality of life in patients with no-option critical limb ischemia underlines the need for new effective treatment. J Vasc Surg. 2010 Oct;52(4):843-9.
8. SAGE. 2007. Critical limb ischemia volume 1, United States Epidemiology. SAGE Group. Atlanta, GA.
9. Yost M. The economic cost of PVD, CLI & venous disease: how big is the market? Paper presented at the New Cardiovascular Horizons annual conference (NCVH), New Orleans, LA. 2016 Jun.
10. Lu XW, Idu MM, Ubbink DT, Legemate DA. Meta-analysis of the clinical effectiveness of venous arterialization for salvage of critically ischemic limbs. Eur J Vasc Endovasc Surg. 2006 May;31(5):493-499.
11. Schreve MA, Minnee RC, Bosma J, Leijdekkers VJ, Idu MM, Vahl AC. Comparative study of venous arterialization and pedal bypass in a patient cohort with critical limb ischemia. Ann Vasc Surg. 2014 Jul;28(5):1123-7.