Prosthetic Heart Valve Devices and Equipment Market:
The prosthetic heart valve devices and equipment market consists of sales of prosthetic heart valve devices and equipment. These devices that are implanted in the heart of patients who have valvular heart disease. The prosthetic heart valve helps in the reduction of discomfort due to a diseased valve in the heart and reduces the risk of mortality. Mechanical heart valves, transcatheter heart valves and tissue heart valves are a few examples of prosthetic heart valves.
The global prosthetic heart valve devices and equipment market was valued at about $1.53 billion in 2018 and is expected to grow to $2.18 billion at a CAGR of 9.3% through 2022.
North America was the largest region in the prosthetic heart valve devices and equipment market in 2016, followed by Western Europe and Asia Pacific. The prosthetic heart valve devices and equipment market in North America is forecasted to register the highest CAGR during 2018-2023.
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Rising prevalence of valvular heart disease has driven the need for Transcathether Aortic Valve Replacement (TAVR) procedures, thus driving the prosthetic heart valve devices and equipment market. TAVR is a minimally-invasive surgical procedure done to cure aortic sthenosis which is a valvular heart disease that affects the aortic valve of the heart. Aortic sthenosis affects the aortic valve by hardening it, thus not allowing blood to properly flow through it and TAVR is used to replace this defective aortic valve with a transcatheter valve. According to the transcatheter valve therapy (TVT) registry, the number of TAVR procedures has increased from 24,808 operations in 2015 to 34,892 operations in 2016 in the USA. As the rate of occurrence of valvular heart diseases rise, the number of TAVR procedures done can be expected to increase which also increases the demand for transcatheter valves, thus driving the market going forward.
Prosthetic heart valve devices have stringent procedures for approval which restrains the growth of the prosthetic heart valve devices and equipment market. According to the US food and drugs administration (FDA), randomized clinical trials are required for any medical device, in order to test for its safety standards. Randomized clinical trial is a clinical method of study that involves the separation of groups of patient subjects using random selection. This is done to compare different medicines and treatment methods in a fair manner with no room for bias and also to detect side-effects, if any. However, these random clinical trials take long periods of time. For example, Abbott Vascular Inc. filed an approval application for their mitraclip delivery system in 2010 and they received their approval for the same in 2019.
Companies in this market are increasingly preferring polymer valves over traditional mechanical and bio-prosthetic valves/tissue valves. Polymer heart valves are prosthetic heart valves made of polymeric materials and have better functioning than tissue and mechanical heart valves. Mechanical heart valves come with a lifelong requirement of using blood-thinning medication to prevent blood clotting whereas bio-prosthetic heart valves come with a short life span that needs several replacements and have a risk of valve degradation. Polymeric heart valves on the other hand supports better blood flow and reduces risk of blood clotting and therefore does not have the disadvantages of tissue and mechanical valves. Therefore, various companies are focusing on development of polymeric heart valve technologies, for example, in 2017, a company named Xeltis received $52 million in funding for working on a polymeric heart valve that can regenerate itself after damage.
The prosthetic heart valve devices and equipment market is monitored by regulatory bodies such as FDA in the US and The Central Drugs Standard Control Organization (CDSCO). For instance, in 2016, CDSCO issued a notice regarding the classification of the risk levels of different medical devices. Under this classification, prosthetic heart valves are considered as class “”D”” or high-risk devices. Similarly, in order for manufacturers to produce and sell prosthetic valve devices in India, they need to sign forms MD-7 and MD-8 which come under the direct purview of the central government of India. Form MD-7 is used to register prosthetic valve manufacturers in India and form MD-8 is used by prosthetic valve manufacturers to apply for loans.
Major players in the market are Boston Scientific, Edward life sciences, Medtronic, Livanova and Abbott.
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