[August 31, 2015]

Peripheral Arterial Disease: A Disease Marked by Leg Pain and Wounds on Legs and Feet

September marks peripheral arterial disease (PAD) awareness month. A staggering 18 million Americans¹ suffer from this potentially life threatening disease which is greater than the number of Americans suffering from stroke (6.8 million)², cancer (13 million)³, and coronary artery disease (16.3 million)⁴. If untreated, those who suffer from PAD are at risk of very serious consequences. The five-year mortality rate is 30 percent⁵, which is greater than the rates for prostate cancer (less than 1 percent)⁶ and breast cancer (11 percent)⁷. For the nearly 3.5 million people who suffer from the worst form of PAD, called critical limb ischemia (CLI)⁸, the five-year mortality rate shoots up to 67 percent⁵ which is greater than that for colorectal cancer (36 percent)⁹ and stroke (41 percent)¹⁰. Despite the severity of PAD, only 26 percent of Americans are familiar with it, making it the most serious disease most people have never heard of.

PAD develops when plaque, like calcium, builds up along blood vessel walls, narrowing the arteries and reducing blood flow to the legs and feet. If PAD progresses to CLI, the most severe and potentially deadly form of PAD, the blood vessels become dangerously narrow and can result in extreme pain, loss of a pulse in feet or legs and wounds that will not heal. In 25 percent of these cases, amputation of toes, the foot or leg is necessary¹¹.

"Considering the high number of people who suffer from PAD and the seriousness of its effects, this disease is disturbingly overlooked," said Mary L. Yost; President/Co-Founder of THE SAGE GROUP, a leading PAD research consulting firm. "People should be aware of the risks, and talk to a physician if they think they may have PAD."

The risk for developing PAD rises with age and is highest for those over 50 years old. Smoking, the single greatest risk factor, increases the chance of developing PAD three to five times. But other common risk factors include diabetes, high blood pressure, abnormal cholesterol levels and heart disease¹².

The symptoms of PAD can often be overlooked by those suffering from the disease, which may allow the disease to progress to a more severe state before it is diagnosed. The most common symptoms are:

• Leg pain that occurs when walking or exercising and disappears when the activity stops
• Tired legs, cramping, heaviness or coldness in the lower legs
• Foot or toe pain at rest that often disturbs sleep: cold or numbness in the feet or toes
• Wounds on the legs or feet that are slow to heal (more associated with CLI)

Fortunately, there are several treatment options for those with PAD that can help patients reclaim their quality of life. According to Dr. Nabil Dib, Director of Cardiovascular Research at Dignity Health and CSI (News - Alert) Medical Advisor, "Lifestyle adjustments, such as quitting smoking and eating healthier, or medications, such as blood thinners, can be effective for many people with PAD. In severe cases, various procedures including minimally invasive vascular surgery or bypass surgery may be necessary to restore blood flow to limbs to prevent an amputation."

David L. Martin, CSI's President and Chief Executive Officer, said, "PAD is a serious condition, but the good news is that it's treatable. As a company, we are committed to partnering with the physicians who treat PAD to increase awareness, diagnosis and treatment to minimize the consequences for the millions of Americans afflicted with PAD."

Visit www.LivingWithPAD.com or www.Take-A-Stand.com to learn more, and talk with your doctor if you think you may be at risk.

References:
1) Schiavetta A, et al. Stem Cells Translational Medicine. 2012; 1:572-578. And Sage Report 2010; 2) Go AS, et al. Circulation. 2014;129:e28 292.; 3) Howlader N, et al. SEER Cancer Statistics Review, 1975-2010. Accessed April 17, 2014.; 4) Dolor RJ, et al. Comparative Effectiveness Reviews, No. 66. 2012 Aug.; 5) Herlitz J, Hjalmarson A, Karlson BW, et al. 5-year mortality rate in patients with suspected acute myocardial infarction in relation to early diagnosis. Cardiology. 1988; 75(4):250-9.; 6) SEER Stat Fact Sheets: Prostate. National Cancer Institute Web site. http://seer.cancer.gov/statfacts/html/prost.html. Accessed April 24, 2013.; 7) SEER Stat Fact Sheets: Breast. National Cancer Center Institute Web site. http://seer.cancer.gov/statfacts/html/breast.html. Accessed April 24, 2013.; 8) Ljungman C, et al. Eur J Vasc Endovasc Surg. 1996; 11:176-182.; 9) SEER Stat Fact Sheets: Colon and Rectum. National Cancer Institute Web site. http://seer.cancer.gov/statfacts/html/colorect.html. Accessed April 24, 2013.; 10) Hartmann A, Rundek T, Mast H, et al. Mortality and causes of death after first ischemic stroke: the Northern Manhattan Stroke Study. Neurology. 2001; 57:2000-2005.; 11) Misra et al. Proceedings from the Society of Interventional Radiology Research Consensus Panel on Critical Limb Ischemia. J Vasc Interv Radiol. 2013; 24(4): 451-458.; 12) Joosten MM, Pai JK, Bertoia ML, et al. Associations Between Conventional Cardiovascular Risk Factors and Risk of Peripheral Artery Disease in Men. JAMA 2012;308(16):1660-1667.

About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company's Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. To date, nearly 210,000 of CSI's devices have been sold to leading institutions across the United States. For more information, visit the company's website at www.csi360.com.

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