About Peripheral Artery Disease

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Peripheral artery disease

Peripheral artery disease (PAD) is a serious medical condition in which stenotic or blocked arteries result from plaque accumulation. The leg arteries are most commonly affected causing diminished blood flow to the feet. This plaque is atherosclerotic, which means it is made of heterogeneous material containing a combination of soft fibrous plaque and hard, calcified plaque. In the leg arteries, the symptoms include claudication, or pain when walking, worsening to pain at rest.

Leg artery art_5

Superficial
Femoral Artery

Popliteal Artery

Tibial Arteries

13 Million affected

In 2016, lower extremity PAD affected nearly 13 million people in the US alone resulting in over 550,000 endovascular procedures in the leg arteries[1]. The peripheral market also includes the arteriovenous (AV) fistula indication; AV access procedures totaled nearly 400,000 in 2016[1]. PAD is growing at an alarming rate (7% per year[2]) due to the increased prevalence of diabetes, obesity, and the aging population.  People are living longer therefore their arteries may develop even more calcified plaque which can increase the severity of the disease.

7% growth rate

PAD is growing at a rate of 7% per year

550,000 procedures

More than 550,000 interventional procedures per year in the US

80,000 amputations

Up to 80,000 amputations occur in the US every year

Mortality Rate

If PAD progresses to CLI, mortality rate is 25% after one year of diagnosis

If left untreated the disease can progress to Critical Limb Ischemia (CLI) which can cause non-healing wounds, tissue loss, and amputation.  It is estimated that there are up to 80,000 amputations per year in the US[3]. If one develops CLI it is estimated that there is a 25% mortality rate at one year after diagnosis[4],[5] . Fortunately, there is an increased interest in endovascular techniques for limb salvage.  The total medical device expenditure for treatment of PAD in the US is $1.7 billion[6].

Limitations of Current Treatment Options

The first treatment option for PAD is for the patient to make lifestyle changes.  Exercise, weight loss, and smoking cessation may help decrease the progression of the disease.  Doctors can also prescribe medications that can aid in managing symptoms, however, sometimes lifestyle changes and medication are not enough. 

The next treatment option is Percutaneous Transluminal Angioplasty (PTA), the most commonly performed procedure for treating atherosclerotic disease. Angioplasty is an uncontrolled balloon inflation often resulting in acute dissection or tearing of tissue inside the artery. This can cause immediate or later obstruction to blood flow. 

Restenosis is the biggest problem that patients encounter after a seemingly successful angioplasty procedure[5[7]. Restenosis of the superficial femoral artery occurs in 40-60% of patients within 6-12 months following a PTA procedure[8],[9].  Stents are often required if there is poor blood flow within the artery; however, the benefits of stents in the peripheral arteries are unclear[9,10] and restenosis remains a problem[11]..

 

[1] DRG US PV Market Report 2017
[2] MRG US # Procedures PV Mkt Report 2013
[3] Sage Group Report 2012 Peripheral Artery Disease
[4] Marianne Brodmann, MD/University of Graz, Graz, Austria Presentation at LINC 2014 as reported in MedTech Insight Device Trends to Watch in 2014, Feb. 2014.
[5] Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD): TransAtlantic Inter-Society Con-sensus (TASC). J Vasc Surg 2000;31:S1-S296.
[6] MedTech Strategist Drug Coated Balloons will they transform PAD Treatment< M. Thompson, December 18, 2014, Vol. 1, No. 6 * Includes Balloons, Stents, Atherectomy, Accessories
[7] Minar E, Pokrajac B, Maca T, et al. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angio-plasty: results of a prospective random-ized study. Circulation 2000;102:2694-9.
[8] Tepe G, Beschorner U, Ruether C, et. al. (2015) Drug-eluting balloon therapy for femoropopliteal occlusive disease: predictors of outcome with a special emphasis on calcium.  J of Endovascular Therapy 22(5): 727-733.
[9] Tepe G, Zeller T, Albrecht T. (2008) Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg.  N Eng J Med 2008; 358:689-99.
[10] Chowdhury MM, McLain AD, Twine CP, (2014) Angioplasty versus bare metal stenting for superficial femoral artery lesions. Cochrane Database Syst Rev 24(6).
[11] Okuno S, Iida O, Shiraki T, et. al. (2016) Impact of calcification on clinical outcomes after endovascular therapy for superficial femoral artery disease: assessment using the peripheral artery calcification scoring system.  J of Endovascular Therapy 23(5):731-737.

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