Coronary artery disease also known as coronary heart disease, is a condition in which small blood vessels that supply blood and oxygen to the heart are blocked. Coronary artery disease is caused due to formation of plaque in the arteries. This plaque is a combination of cholesterol and other substances in the artery. This plaque results in the narrowing of arteries which will further lead to blockage of blood flow. This blockage of blood is also known as atherosclerosis. Symptoms of coronary artery disease are angina, chest pain, fatigue and shortness of breath. The risk factors associated with coronary artery disease are heredity, increasing age, hypertension, obesity, stress, physical inactivity, diabetes, smoking and cholesterol level in blood. Complications associated with coronary artery disease are heart failure, angina, heart attack and arrhythmia.
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A biodegradable stent is a small expandable mesh tube that is placed in arteries to avert them from collapsing after a blockage has been removed and then are biodegraded. Biodegradable stents are used in coronary artery disease. They are also known as bioabsorbable stents and are alternatives to permanent stents. They deliver high amount of drug to the target site, improved lesion imaging, vasomotion restoration, allow restoration of vasoreactivity, and decreased risk of stent restenosis and thrombosis. Lastly, biodegradable stents are compatible with MSCT and MRI imaging. Biodegradable stents are made from polymers and metals and these polymers are selected on the basis of lack of toxicity, strength, biocompatibility with vessel wall, and rate of corrosion and degradation. There are four types of polymers used in manufacturing of biodegradable stents, namely, poly (D, L-lactide/glycolide) copolymer (PDLA), Poly L-lactic acid (PLLA), Polycaprolactone (PCL) and Polyglycolic acid (PGA). Polymeric stents act as local drug delivery systems and are used for controlled release of drugs. They prevent prevention intimal proliferation and thrombus formation. There are two types of metals used in manufacturing of biodegradable stents, namely, magnesium and iron. Biodegradable magnesium stents have high radial strength as they are biocompatible with the body and due to their metallic nature. Iron stents are favorable stents as iron is a crucial component of variety of enzymes. These metal biodegradable stents perform similarly to steel metal stents.
The major factor driving the biodegradable stents market is increasing incidence of cardiovascular diseases. For instance, according to American Heart Association, in 2016, about 92.1 million adults in U.S. were suffering from some form of cardiovascular disease or the after-effects of a stroke. It also states that in U.S., once in every 40 seconds someone has a stroke. Moreover, the rise in the geriatric population is another important factor that will drive this market. According to WHO, in 2015, 900 million people were 60 years of age or older and this number is expected to reach up to 2 billion by 2050. Further, companies focusing on clinical trials of biodegradable stents will fuel the growth of this market. For instance, in February 2015, BIOTRONIK, Inc. completed trial enrollment for Dreams Bioresorbable stent after many delays. However, high risks of complications associated with biodegradable stents and high pricing will hamper the growth of biodegradable stents market.
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The key strategy followed by the major players in the market is product launch to become a pioneer and gain more market share. For instance in July 2016, FDA approved Absorb, a bioresorbable stent from Abbott Laboratories. It is the only fully dissolving heart stent and will offer treatment options to candidates who are going for angioplasty but do not prefer permanent coronary stent. The launch of Absorb will help Abbott Laboratories to become a pioneer in the market and gain more share.
The major players in the biodegradable stents market are BIOTRONIK, Inc., Abbott Laboratories, Terumo Corporation, Elixir Medical Corporation, Kyoto Medical Planning and Boston Scientific Corporation
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