Prosthetic Heart Valve Devices And Equipment Global Market Report 2022
Major players in the prosthetic heart valve devices and equipment market are Boston Scientific, Edward life sciences, Medtronic, Livanova, Abbott, Jenavalve technology, Lepu medical, Cryolife, Neovasc Inc, and St.
New York, May 13, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Prosthetic Heart Valve Devices And Equipment Global Market Report 2022" - https://www.reportlinker.com/p06277199/?utm_source=GNW
Jude medical.
The global prosthetic heart valve devices and equipment market is expected to grow from $4.47 billion in 2021 to $5.04 billion in 2022 at a compound annual growth rate (CAGR) of 12.6%. The market is expected to grow to $7.54 billion in 2026 at a compound annual growth rate (CAGR) of 10.6%.
The prosthetic heart valve devices and equipment market consist of sales of prosthetic heart valve devices and equipment.These devices 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.
The main types of prosthetic heart valve devices and equipment are transcatheter heart valve, tissue heart valve, and mechanical heart valve.Transcatheter aortic valve replacement is an invasive heart procedure to replace a thickened aortic valve that will not fully open.
The product types are repair products, mitral valve repair devices, and tricuspid valve repair devices. The technologies involved in prosthetic heart valve devices and equipment are biological valves and decellularized valves that are used in various applications such as hospitals and ambulatory surgery centers.
North America was the largest region in prosthetic heart valve devices and equipment market in 2021.Western Europe was the second-largest region in prosthetic heart valve devices and equipment market.
The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, the Middle East, and Africa.
The rising prevalence of valvular heart disease has driven the need for transcatheter 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 stenosis which is a valvular heart disease that affects the aortic valve of the heart.
Aortic stenosis 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 a report from The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT Registry, volumes have grown every year.
In 2019 TAVR passed all forms of surgical aortic valve replacement (SAVR) for the initial time. According to the U.S. Food and Drug Administration (FDA) approval of TAVR for low-risk patients, the annual size of TAVR has increased every year and in 2019, TAVR volume (72,991) passed all forms of SAVR (57,626). As the rate of occurrence of valvular heart diseases rises, 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, to test for its safety standards.
A 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 fairly with no room for bias and also to detect side effects if any.
However, these random clinical trials take long periods. 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 bioprosthetic 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 support better blood flow and reduce the risk of blood clotting and therefore do not have the disadvantages of tissue and mechanical valves.
Therefore, various companies are focusing on the development of polymeric heart valve technologies, For instance, in October 2019, the California Institute of Technology and Foldax announced the development of the Tria heart valve that combines LifePolymer, an advanced biopolymer material, and a patented bio-inspired design to offer a heart valve able of serving for 15 years without calcification, risk of clotting, or damage to red blood cells.
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, CDSCO issued a notice regarding the classification of the risk levels of different medical devices.
Under this classification, prosthetic heart valves are considered a class D or high-risk device.Similarly, 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.
The countries covered in the prosthetic heart valve devices and equipment market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, the UK, the USA, and Australia.
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