Since the medical community has begun to focus on AF in earnest in recent years, the condition, its diagnosis, and treatment have received substantial attention from the medtech industry. Many leading vascular firms have identified AF ablation as an area for growth opportunity. Manufacturers such as St. Jude Medical and Medtronic have begun earmarking funds towards research and development,as well marketing efforts focusing on AF ablation technologies.
The introduction of advanced technologies—such as electrophysiology (EP) ablation catheters—will help capitalize on the growing physician demand, as will the expanding treatable patient population. Adoption of these premium-priced technologies will fuel revenue gains at a doubledigit rate in the coming years in the global AF market. Because many devices often gain approval in Europe before entering the US, European market performance can act as a bellwether for device performance in the larger US market, despite the regional differences in adoption between Europe and the US. The European market for AF devices, and particularly for EP ablation catheters, is set to grow robustly over the next several years. The combined markets of France, Germany, Italy, and the UK will skyrocket from a 2008 value of over $50 million to reach more than $130 million by 2013.
Pharmaceuticals have long been the go-to treatment for AF, but devices are coming into their own as valid second-line options. EP catheter ablation in particular is gaining favor as a minimally invasive therapy, particularly since the technology has the ability to cure AF, rather than just manage its symptoms, as pharmaceuticals do. During EP catheter ablation, the physician guides an ablation catheter through the patient’s vasculature into the heart. Once properly positioned, the catheter is maneuvered to make contact with the faulty cardiac tissue, and by delivering energy to the target site, the tissue is destroyed, in effect curing AF. The treatment’s efficacy has proven popular across Europe, particularly in Germany, where physicians have been quick to adopt EP catheter ablation. A predominant growth driver in the coming years will be the continued launch of increasingly sophisticated technology.
Newer devices aim specifically to treat the condition in safer and more effective manner. For example, recently released devices include those that treat specific anatomy (pulmonary veins), as well as remote steering systems that allow physicians to more accurately target faulty tissue. Advanced AF ablation devices that have been released in Europe but not in the US include Biosense Webster’s NaviStar ThermoCool irrigated-tip
ablation catheter, Medtronic’s Cardiac Ablation System RF ablation catheter,and Arctic Front cryoballoon, and C. R.Bard’s HD Mesh, an RF ablation catheter specifically developed for AF treatment.
As manufacturers prepare for US launch over the coming years, they will no doubt be watching European market adoption patterns. Certain barriers will, however, restrict the growth of advanced EP ablation catheter revenues in Europe. Most limiting to revenues will be facility financial stress. European hospitals tend to be budget constrained in the best of times, and thus the fallout from the credit crisis and the resulting economic recession has hit hospitals hard. Since many of the advanced EP ablation devices command a premium price, payers at hospitals will be reluctant to purchase these devices. Further costcutting measures will prompt hospitals to resterilize and/or reuse EP ablation catheters. In Germany, where procedure numbers are the highest of all countries covered, the impact of device reprocessing will be particularly felt.
Also limiting the revenue growth is the cost-constrained reimbursement environment in Europe. Attempts to curb costs by cutting reimbursement will force price erosion in all four countries, with cuts most visible in France and Germany. Despite reimbursement issues, in Italy and the UK procedures will grow very quickly, as physicians in those countries have more readily adopted AF catheter ablation. Procedure growth will plateau by around 2011, however, as the treatable patient population shrinks. Established and emerging manufacturers are all looking for a slice of share in the European EP catheter ablation market.
Biosense Webster, leader of the global EP AF treatment device market in 2008, focuses exclusively on the EP device space. As a pioneer of many advanced technologies in the EP catheter ablation market, such as 3-D mapping and irrigated-tip radiofrequency (RF) catheter ablation, the company has established a solid reputation. Medtronic also has a strong presence in the EP ablation catheter market, although it has a limited selection of advanced products. The company’s advanced EP ablation solution, the Sprinklr irrigated-tip RF ablation catheter, is offered in Europe. In early 2009, Medtronic announced the formation of its AF Solutions franchise, which aims to develop AF ablation therapies that are simpler and faster to perform compared to current procedures. St. Jude Medical has identified the AF treatment device market as a key growth opportunity, and EP devices are high-profile products for the company. Historically, St. Jude Medical has diversified its EP product portfolio through the strategic acquisition of companies such as Endocardial Solutions, Irvine Biomedical, and most recently in the second quarter of 2008, EP MedSystems. The company is focusing its efforts on developing products that simplify procedures and reduce risk of complications, and plans to expand its offerings in the EP diagnostic and ablation catheter markets. Other competitors in the European market include C.R. Bard and Boston Scientific, as well as a number of nontraditional vascular companies such as SiemensHealthcare and Philips Healthcare. Given the growing number of firms competing in this field, the struggle for share will intensify in the coming years. IQ