(Health-NewsWire.Net, April 15, 2020 ) Market Overview The Global Prosthetic Heart Valve Market is expected to grow at a high CAGR during the forecasting period (2019-2026). The prosthetic heart valve is surgically implanted in the heart to replace a heart valve that has been damaged due to heart-related disorder. Heart valve replacement surgery is performed when repair of the valve is not an option; each valve has a tissue flap that opens and closes with every heartbeat. The function of the flap is to ensure that blood flows in the right direction through the four chambers of the heart and to the rest of the body. When one of the four heart valves malfunctions, then the natural valve is replaced with an artificial valve.
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Market Dynamics Regulatory approvals for new and advanced prosthetic heart valve are one of the key factors fueling the global prosthetic heart valve market. For instance, in March 2018, Abbott has received U.S. Food and Drug Administration (FDA) approval for masters HP 15mm rotatable mechanical heart valve, it is the worlds smallest automatic heart valve, that will allow treating babies and toddlers in need of a mitral or aortic valve replacement. In January 2019, Edwards Lifesciences Corp. has received FDA approval for Sapien 3 Ultra system, it is a transcatheter aortic valve replacement device. In July 2017, Edwards Lifesciences Corporation has received U.S. Food and Drug Administration (FDA) approval for its INSPIRIS RESILIA aortic valve, the first in a new class of resilient heart valves. In October 2015, Edwards Lifesciences Corporation has received U.S. Food and Drug Administration (FDA) approval for aortic valve-in-valve procedures using the Edwards SAPIEN XT transcatheter heart valve.
Segmentation Analysis Based on the product the global market for prosthetic heart valve is broadly segmented as by transcatheter heart valve, tissue heart valve, and mechanical heart valve. Currently, the transcatheter heart valve is a dominant segment, and it accounts for approximately XX% of the market in 2018, due to the launch of new products and regulatory approval for a transcatheter heart valve. For instance, in December 2018, Meril Life Sciences have introduced the Myval transcatheter aortic heart valve in India. TAVR is an established treatment modality for patients who are at high risk or unwilling to undergo open heart valve replacement surgery. In November 2018, Edwards Lifesciences Corporation has received CE Mark for the SAPIEN 3 Ultra system for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients. In June 2017, Edwards Lifesciences Corporation has received U.S. Food and Drug Administration (FDA) approval for aortic and mitral valve-in-valve procedures using the Edwards SAPIEN 3 transcatheter heart valve. The SAPIEN 3 valve is the first transcatheter heart valve approved in the U.S. for the treatment of both aortic and mitral patients who are at high risk for a subsequent open-heart surgery to replace their bioprosthetic valve.
Geographical Share The global prosthetic heart valve market is segmented into North America, Europe, Asia Pacific, South America and the Middle East and Africa. North America is dominating the global prosthetic heart valve market, due to the increase in cases of heart valve disease. For instance, According to Alliance for Aging Research, in 2016, 11.6 million Americans in the U.S. have heart valve disease (HVD), and more than 1 in 10 adults ages 75 and older have HVD. Approximately 2.5% of U.S population has heart valve diseases. More than 25000 Americans die from heart valve diseases each year. In 2016, 5.8 million U.S. adults had aortic valve disease (AVD). Aortic stenosis (AS) is among the most common forms of heart valve disease (HVD), affecting 2% to 3% of the adult U.S. population. In 2016, 12.4%, which is 2.5 million people ages above 75 in North America, have aortic stenosis.
Competitive Analysis The strategic agreements between companies are one of the key factors driving the global prosthetic heart valve market. For instance, in January 2019, Abbott, have acquired Cephea Valve Technologies, Inc., a privately held medical device company developing a less-invasive heart valve replacement technology for people with mitral valve disease. In December 2015, CryoLife, Inc., a leading medical device and tissue processing company focused on cardiac and vascular surgery, have entered into a definitive agreement to acquire On-X Life Technologies Holdings, Inc., the company provide mechanical heart valve systems. In March 2017, Boston Scientific Corporation, has entered into a definitive agreement to acquire Symetis SA, a privately-held Swiss structural heart company focused on minimally-invasive transcatheter aortic valve implantation (TAVI) devices, the deal was valued for 435 million. Some of the major market players: Edwards Lifesciences Corporation, Medtronic plc, Ivanova PLC, Abbott Laboratories, Jenavalve Technology, Inc., Lepu Medical Technology Co., Ltd. CryoLife, Inc., Boston Scientific Corporation, Neovasc Inc, and Colibri Heart Valve, LLC.
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