Cardiology Stents: Introduction
- Cardiology stents are tubes placed in the coronary artery to clear artery blockages or coronary artery stenosis. They are utilized in a procedure called percutaneous coronary intervention (PCI) or coronary angioplasty.
- This procedure is a minimally invasive procedure to treat stenosis or narrowing of the coronary arteries. Technology plays an indispensable role in the global cardiology stents market. Manufacturers undertake rigorous research and development initiatives to develop nascent products that are functionally superior to their previous versions.
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Rise in number of dialysis centers across the world
- Changes in lifestyle and controlling rapidly rising obesity rate are major factors considered for the treatment of cardio vascular disease (CVD). Percutaneous coronary intervention has become a standard treatment option preferred across the globe for CVD.
- CVDs are listed as a major cause of mortality across the world, responsible for one in every three deaths in the U.S. According to the American Heart Association, coronary heart disease is a prominent cause of death, accounting for 45% of all the deaths in the U.S. occurring due to heart diseases each year.
- Occurrence of restenosis after angioplasty procedure boosts the adoption of novel stents, such as drug-eluting and bioresorbable, which are known to drastically reduce the frequency of restenosis
- Increase in awareness about the technological innovations in interventional cardiology and cost effectiveness of the procedure propel stents production
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Stringent Regulations for Product Approvals
- Approval of medical devices is considered to be expensive. Coronary stents fall under the category III devices of the U.S. FDA. These devices require submission and approval of pre-market approval (PMA) application prior to commercial marketing in the U.S.
- The requirements of clinical and pre-clinical data for stents engage the sponsor and manufacturer for a long period of time. Resources of manufacturers and investors such as time and money are spent on conducting safety testing and clinical pharmacology and toxicology testing of drug substance in case of DES. The FDA’s regulatory procedures are comparatively time-consuming as compared to that of EMA. Hence, commercialization of stents takes more time in the U.S. as compared to that in Europe.
- In 2011, Abbott Vascular received marketing approval for its first bioresorbable stent in Europe, while the same device received the FDA approval in the U.S. in 2016
- Hence, prolonged procedures of drug approval by regulatory authorities in the U.S. deter manufacturers from opting for development and commercialization of stents
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Cardiology Stents Market: Segmentation
- In terms of product, the global cardiology stents market can be divided into bare metal stents, drug-eluting stents, bioresorbable stents, and others
- In terms of application, the global cardiology stents market can be split into coronary artery, carotid artery, iliac artery, and others
- Based on end-user, the global cardiology stents market can be segregated into hospitals, specialty clinics, and others
Asia Pacific Cardiology Stents Market to Expand at a Rapid Pace
- In terms of region, the global cardiology stents market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa
- North America dominates the global cardiology stents market, followed by Europe and Asia Pacific nations such as Japan and China. High geriatric population, lifestyle changes leading to obesity and related health complications, and the advent of advanced technologies such as bio-absorbable and next generation stents are major factors driving the global cardiology stents market.
- However, high cost of coronary stents, lack of reimbursement policies in some regions, and complications such as in-stent restenosis or thrombosis are major factors restraining the global market. However, novel technologies in clinical trials to address the unmet needs and emerging economies such as China, India, Brazil and others are likely to offer significant opportunities to manufacturers operating in the market.
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