Transcatheter aortic valve implantation (TAVI), also referred as transcatheter aortic valve replacement, or percutaneous valve replacement is a minimally invasive procedure that repairs the functionality of the old and damaged valve. The aortic valve allows the blood flow from the ventricle to the rest of the body. A malfunction in the opening and closing of this valve leads to aortic stenosis. The patients suffering from aortic stenosis suffer from extra strain on the heart, which causes swelling in the ankles, breathlessness, dizziness, chest pain, and frequent black outs. The transcatheter aortic valve implantation is a procedure that allows replacement of the aortic valve by implantation of a catheter. Catheter is a long narrow tube that is inserted in the blood vessel by making a small incision in the chest. The transcatheter aortic valves are made from natural tissues of either a pig or a cow. This natural tissue isolated from the heart of a pig or cow is then re-engineered and reprocessed by attaching the valve to a flexible and expandable mesh frame. Once the new valve is implanted, the catheter is removed and the valve starts functioning normally.
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High prevalence of aortic stenosis is responsible for growth of the global transcatheter aortic valve implantation market
According to the Virtual Medical Centre (VMC) 2017, one in every four people suffer from congenital valvular disease that may lead to the development of Aortic stenosis at a young age. Additionally, people aged 65 years and above are more likely to have degenerative aortic stenosis due to calcification of the aortic valve or atherosclerosis. Moreover, the American Heart Association statistics of 2017, states that around 2200 deaths are experienced in the U.S. due to cardiovascular diseases each day, accounting for 1 death every 40 seconds. .The same report also suggests that the coronary heart disease is the leading cause of death in the U.S. accounting for 45.1% of deaths in the country. The rise in prevalence of cardiovascular diseases and aortic stenosis provides immense opportunities for key players to expand products and increase sales over the forecast period.
Europe holds a dominant position in the global transcatheter aortic valve implantation market
On the basis of geography, the global transcatheter aortic valve implantation market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Europe holds the maximum share of the global transcatheter aortic valve implantation market, attributing to the high prevalence of aortic stenosis in the European countries. The transcatheter aortic valve implantation is a well- established procedure offering reimbursement in most of the European countries and have specific procedure codes for TAVI, except for Italy. North America is also focusing on expansion of the TAVI market by investing in R&D for innovative transcatheter aortic valve implants. For instance, the U.S. FDA approved an expanded indication for the Sapien 3 transcatheter heart valve in June 2017. Asia Pacific is also expected to exhibit increased market growth over the recent future, owing to the introduction of novel and innovative products for the treatment of aortic stenosis. For example, the Food and Drug Administration of China recently approved a new generation valve replacement product called as J- Valve, which is expected to greatly reduce the surgical time as well as increase the rate of survival for most patients.
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The clinical trial success of the FDA approved devices drives growth of the global transcatheter aortic implantation market
Several novel TAVI devices that are in the last phases of the clinical trials. For instance, in 2016, the SAPIEN XT by the Edward Lifesciences has been FDA-approved and is now in the clinical phase trial serving patients with intermediate risk. This serves as one of the prime reasons for growth of the global transcatheter aortic valve implants market. Moreover, the success rate of the TAVI surgeries coupled with shorter recovery time also help drive the global transcatheter aortic implantation market growth. Apart from this, the high prevalence rates of aortic stenosis and coronary artery diseases in the geriatric population and younger population contributes to growth of the global transcatheter aortic implantation market. An article by National Centre for Biotechnology Information (NCBI) stated that aortic stenosis exists in 2%-9% of the population aged above 65 years. The number of centers providing the TAVI surgical process is gradually increasing, thereby creating a wide scope for key players to expand their distribution channels. According to the Edward Lifesciences, the TAVR procedure was available at more than 400 centers in the U.S., in 2015. However, stringent regulatory procedures for approval of new products that are also time consuming, are restraining the growth of the global transcatheter aortic valve implantation market.
The key players operating in the global transcatheter aortic valve implantation market include Direct Flow Medical Inc., Edwards Lifesciences, Boston Scientific Corporartion, Jenavalve Technology, Inc., HLT, Inc., Meril Life Sciences Pvt. Ltd., Medtronic Plc., St. Jude Medical, Inc., Transcatheter Technologies GmbH, and SYMETIS SA.