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 over 153,000 amputations per year in the US5. If one develops CLI it is estimated that there is a 25% mortality rate at one year after diagnosis.6,7 The total medical device expenditure for treatment of PAD in the US is $1.7 billion.8
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 medication that can help to manage 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 balloon inflation often resulting in uncontrolled tissue dissection or tearing of tissue inside the artery. This can cause immediate or later obstruction to blood flow and often requires placement of a stent. Restenosis is the biggest problem that patients encounter after a seemingly successful angioplasty procedure.7,9 Restenosis of the superficial femoral artery occurs in 40-60% of patients within 6-12 months following a PTA procedure.10,11 Stents are often required if there is poor blood flow within the artery; however, the benefits of stents in the peripheral arteries are unclear11,12 and restenosis remains a problem.13
The Cagent Vascular Solution
Serration Technology is designed to address these shortcomings of PTA.
1Fowkes FGR, Rudan D, Rudan I, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: A systematic review and analysis. Lancet 2013; October 19, 2013.
2MRG 2013 Report: PV market
3Davies M, Waldman D, Pearson T, (2005) Comprehensive endovascular therapy for femoropopliteal arterial atherosclerotic occlusive disease. J American College of Surgeons 201(2): 275-296.
4MRG US # Procedures PV Mkt Report 2013
5Sage Group Report 2012 Peripheral Artery Disease
6Marianne Brodmann, MD/University of Graz, Graz, Austria Presentation at LINC 2014 as reported in MedTech Insight Device Trends to Watch in 2014, Feb. 2014.
7Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD): TransAtlantic Inter-Society Con-sensus (TASC). J Vasc Surg 2000;31:S1-S296.
8MedTech Strategist Drug Coated Balloons will they transform PAD Treatment< M. Thompson, December 18, 2014, Vol. 1, No. 6 * Includes Balloons, Stents, Atherectomy, Accessories
9Minar 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.
10Tepe 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.
11Tepe 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.
12Chowdhury MM, McLain AD, Twine CP, (2014) Angioplasty versus bare metal stenting for superficial femoral artery lesions. Cochrane Database Syst Rev 24(6).
13Okuno 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.