September marks Peripheral Artery Disease (PAD) Awareness Month. Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), has launched a public awareness and patient advocacy program, Take A Stand Against Amputation, to provide education about the disease and treatment options.

Up to a staggering 18 million Americans1 suffer from this potentially life-threatening disease. According to the American Heart Association, PAD patients have a six to seven times greater risk of coronary artery disease, heart attack and stroke than the rest of the population. If left untreated, those who suffer from PAD are at risk of serious consequences. In fact, each year 160,000 to 180,000 Americans undergo amputation of a limb as a result of complications associated with peripheral artery disease (PAD)2.

Of those suffering from PAD, up to 3.5 million have progressed to critical limb ischemia (CLI)3, the most severe and potentially deadly form of PAD, where the blood vessels become dangerously narrow, leading to pain at rest, open sores on toes and feet, or gangrene. If left untreated, this can lead to amputation of toes, a foot or even a leg. Despite the severity of PAD, many Americans are not familiar with it, making it a large and growing problem in the United States.

CSI wants to raise awareness of Peripheral Artery Disease. Early screening and treatment are crucial. This program also focuses on increasing awareness of CLI, the advanced stages of PAD, which puts people at high risk of amputation, and stresses that there are treatment options. CSI’s goal with this program is to raise awareness and reduce the number of amputations to under 100,000 within three years. The Take A Stand Against Amputation website, www.StandAgainstAmputation.com, contains information about PAD and CLI for people with PAD, those who are concerned they may have PAD, and their families and caregivers. The website also contains materials physicians can use to educate people about the disease.

During PAD Awareness Month and year-round, CSI encourages the public and physicians to take advantage of the educational resources to learn more about this dangerous disease—the risk factors, the symptoms and the treatment options—in order to help save limbs. With a proper diagnosis and treatment plan, most people can manage the symptoms of PAD, with their doctor’s help, to avoid the worst complications, such as amputation.

One in 20 Americans over the age of 50 has PAD4, and among adults age 65 and older, 12 to 20 percent may have PAD5. 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 disease6. In fact, one in three people over the age of 50 with diabetes has PAD7. Those people with diabetes and PAD have a ten times greater risk of amputation than people without diabetes7.

“Considering the high number of people who suffer from PAD and the seriousness of its effects, this disease is disturbingly overlooked,” said Mary 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 symptoms of PAD can often be mistaken for symptoms of aging 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
• Leg muscle tiredness, heaviness, or cramping
• Leg and/or foot pain that disturbs sleep
• One leg/foot feels cooler than the other
• Toes or feet that look pale, discolored or blue
• Thick or yellow toenails that aren’t growing
• Sores/wounds on toes, feet or legs that heal slowly, or not at all (more associated with CLI)

PAD is a serious condition for which early diagnosis and treatment are very important. The good news is there are treatment options for PAD that your doctor can prescribe to help you reclaim your quality of life. Treatment options can include lifestyle adjustments, such as quitting smoking and eating healthier; as well as medications for many people with PAD. In more severe cases, procedures including minimally invasive vascular procedures or bypass surgery may be necessary to restore blood flow to the feet to help prevent an amputation.

Dr. Bryan Fisher, a vascular surgeon from Tri-Star Centennial Medical Center in Nashville, Tennessee, said PAD Awareness Month presents an opportunity to ensure that patients know they have treatment options.

“If someone receives a diagnosis of PAD or CLI and the recommended treatment is amputation, they should ask for a second opinion,” said Dr. Fisher. “There have been important advances that enable more treatment options that may prevent the need for amputation, or at least lessen the impact.”

Dr. Fisher also encourages other physicians—especially primary care physicians, podiatrists and wound care specialists—to become educated about these new treatment options. These healthcare professionals are often the first to learn about or see first-hand the symptoms of PAD.

“These healthcare professionals can find specialists in their area who can help them deliver improved outcomes for their patients,” Dr. Fisher said. “This disease can have a serious impact on the quality of people’s lives, and appropriate treatment can help them get back to living more fulfilling lives.”

Talk with a doctor if you think you may be at risk. And for more information, visit www.StandAgainstAmputation.com.

References:
1) Schiavetta A, et al. Stem Cells Translational Medicine. 2012; 1:572-578. and Sage Report 2010; 2) Allie et al. J Endovasc Ther. 2009 Feb; 16 Suppl 1:134-46; 3) Schiavetta A, et al. Stem Cells Translational Medicine. 2012; 1:572-578. And Sage Report 2010; 4) Stay in Circulation. Peripheral Artery Disease.
National Heart, Lung, and Blood Institute (NIH)
http://www.nhlbi.nih.gov/health/educational/pad/. Accessed 09Mar2016; 5) Mahameed, AJ. Peripheral Arterial Disease. From the Cleveland Clinic Foundation Center for Continuing Education Disease Management series, January, 2009. http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/cardiology/peripheral-arterial-disease/; 6) 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; 7) Living With Diabetes. Peripheral Arterial Disease. American Diabetes Association Website.
http://www.diabetes.org/living-with-diabetes/complications/heart-disease/peripheral-arterial-disease.html?loc=foot-complication. Accessed 09Mar2016.; 8) 12.Graziani L, Piaggesi A. Indications and Clinical Outcomes for Below Knee Endovascular Therapy: Review Article. Catheterization and Cardiovascular Interventions. 2010; 75:433–443.

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. The Stealth 360® Peripheral Orbital Atherectomy System (OAS) received CE Mark in October 2014. To date, over 260,000 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.

About Take A Stand Against Amputation

Take A Stand Against Amputation is a national, year-round campaign supported by Cardiovascular Systems, Inc., St. Paul, Minnesota. At its centerpiece, the campaign utilizes a website—www.StandAgainstAmputation.com—to offer education for people about Peripheral Artery Disease. The website includes a PAD risk factor checklist people can use with their healthcare professionals to help assess their risk. It also provides a tool to help people find a physician or surgeon who specializes in the diagnosis and treatment of PAD. For physicians, the website offers free education tools they can download, print and distribute to their patients.

About PAD Awareness Month

The National Institutes of Health (NIH)’s National Heart, Lung and Blood Institute (NHLBI) created PAD Awareness Month to educate people about the disease. For more information, visit http://www.nhlbi.nih.gov/health/health-topics/topics/pad or http://www.nhlbi.nih.gov/health/educational/pad/.

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