New Report Examines the Impact of New Technologies and the Growth of the Various Sectors of the Cardiovascular Device Market in the US

Research and Markets (http://www.researchandmarkets.com/reports/c79403) has announced the addition of Global Cardiovascular Device Markets 2007-2012 to their offering.

Global Cardiovascular Device Markets 2007-2012 is a comprehensive analysis of this important global market and predicts strong growth over the next five years.

This report covers devices for diagnosing and treating cardiac rhythm disorders, coronary artery disease, heart value disorders and end-stage heart failure.

This report will help you:

– Plan your market strategy for the next 5 years

– Identify partnership/investment opportunities

– Analyse the market position of your competitors

– Identify new technologies for licensing

– Assess the competitive landscape for your products

This comprehensive, 250-page report will provide a detailed analysis of:

– Primary segments of the cardiovascular devices market

– Overview of suppliers in the cardiovascular devices market

– Mergers and acquisitions in the cardiovascular devices industry

– Regulatory framework and issues for cardiovascular devices

– Technology developments and trends

– Market application segments

– Trends in individual country markets

– Impact of emerging technologies on competitive structure

The economic cost of cardiovascular disease (CVD) and stroke, a potential consequence of CVD, is of staggering proportions, estimated by the American Heart Association and the National Heart, Lung, and Blood Institute to be $403.1 billion in 2006. As a result of such high demand the cardiovascular segment is one of the most fiercely fought over by medical device companies which are investing heavily in device-based therapies that have the capability to cost effectively treat CVD patients.

Competition between medical device companies in the market is increasingly intense and as a consequence merger and acquisition activity rose dramatically in the sector in 2006 and has continued into 2007. Part of this rise can be attributed to an expanding US economy, increases in corporate profits and stock prices, technological improvements, and growing product demand. The large cardiovascular deals in 2006 were Boston Scientific taking Guidant in a landmark $27 billion deal, the acquisition of Guidants vascular and endovascular businesses by Abbott for $4.1 billion and J&Js purchase of stent maker Conor Medsystems for $1.4 billion. However there have been a number of smaller but also significant deals such as ATS Medical, in a bid to flesh out its cardiac surgery product line, acquiring 3F Therapeutics, an early-stage company specialising in minimally-invasive, beating heart tissue valve replacements, and, in 2007 acquiring the surgical cryoablation business of CryoCath Technologies.

The two big sectors of the cardiovascular market where there are the most valuable markets to conquer are coronary stents and cardiac rhythm management devices.

Following balloon angioplasty procedures, approximately 30% of coronary arteries are affected by this complication. The launch of bare metal coronary stents in the 1990s went some way towards alleviating this problem but the bare metal stents continue to be associated with a restenosis rate of around 25% of patients being affected six months after stent insertion. Drug eluting stents attracted increasing attention during the 1990s as potentially offering a more effective way to lower the rate of restenosis to single figures. Drug eluting stents (DES) have certainly made their mark with the value of the US market alone rising from $1.1 billion in 2004 to $3.1 billion in 2006. Cordis’ Cypher stent was released in the European and US markets in 2003 and Boston Scientific entered the European market in 2003 and the US market in March 2004 with the Taxus stent. This product allowed Boston Scientifc to successfully challenge Cordis, gaining market share overall and winning approximately two thirds of the US market in its first year of launch.

These two companies, Cordis and Boston Scientific remain locked in a battle for dominance of the drug eluting stent market. Both companies however suffered setbacks from product recalls and this had a strong effect on the market, causing a fall in use. In addition some recent long-term studies have suggested that there has been overuse of DES, which again may affect DES utilisation rates. Factors which will buoy the market up are new stent designs that create a balance between low profile, flexibility, ease of deployment and sufficient endoluminal surface coverage. Newer alloys such as cobalt chromium are helping fulfil these design goals. Two new stents on the market use this alloy: the Xience V everolimus-eluting coronary stent system of Abbott Vascular and the Endeavor stent of Medtronic. Both of these have received European approval and are awaiting US market authorisation. When these do hit the US market, however, their impact is forecast to be significant. Results from the SPIRIT series of trials, for example, suggest that the Xience V is slightly more effective than the Taxus stent. This in combination with the fact that some cardiologists, due to product recalls, have become a little wary of the DES of J&J and Boston Scientific and that, despite certain contract tie-ins to particular companies, cardiologists are ever seeking to try new more cost-effective products, will assure Abbott and Medtronic a warm welcome onto the market.

Just as there has been consolidation in the stent market this has also occurred in the cardiac rhythm management (CRM) sector and three companies: Medtronic, Boston Scientific and St Jude Medical hold approximately 90% of the market share.

The pacemakers market was also impacted by device recalls in 2005 and while the overall world CRM market grew by 3%, the US market declined in 2005 compared to 2004. Even companies that did not have any device recalls reported a year-over-year loss in total pacemaker sales for 2005. This dip in the market can be directly related to an oversaturated market combined with a loss of consumer confidence due to electrostimulation device recalls. Medtronic, Guidant, and St Jude Medical all announced potential defects in certain models. Medtronic recalled about 87,000 ICDs because of evidence that the batteries might fail. Guidant recalled about 50,000 ICDs for possible malfunctions, including a short-circuiting flaw and also reported a faulty switch problem that might impair the function of another 45,000 ICDs. St. Jude Medical reported a software problem that could lead to a malfunction in 39,000 ICDs and recalled about 28,000 pacemakers because of a potentially defective seal that could leak and allow moisture to enter the devices. Such recalls have prevented ICD manufacturers from capitalising on its new era of expanded reimbursement coverage.

Considering that pacemakers have functioned like clockwork with minimal safety concerns, most physicians expected the same from lCD devices as well, but the recent events forced them to go back and re evaluate these devices based on clinical trial and performance reports. A major help was that in 2005 the European Society of Cardiology update of Guidelines for the diagnosis and treatment of chronic heart failure for the first time, made formal recommendations on the use of device therapy for patients with moderate to severe heart failure. In light of compelling evidence demonstrating the benefits of implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy (CRT), these guidelines recommended that these devices be considered as standard-of-care in appropriate patients. Despite such recommendations recovery has been slow but, in 2007, companies were reporting an upturn in fortunes. St Jude Medical, for example stated that its fourth-quarter sales of ICDs totalled $289 million, which was toward the upper end of its expectations. St Jude, which previously warned of a slowdown in the heart device market, said it now expects earnings of about 42 cents a share for the fourth quarter having previously forecast 38 cents to 40 cents a share.

Although not as large as the vascular intervention or CRM markets a sector that is gaining a lot of attention is the artificial heart valve market. There are two main types of artificial heart valves: mechanical and tissue valves or bioprostheses. Whereas bioprostheses do not require anticoagulation, they are not as durable as mechanical valves. On average, structural tissue valve degeneration occurs between 10 and 15 years after implantation (depending on patient age at the time of implantation). These valves are usually used for elderly patients whose life expectancies are less than the life span of a bioprosthesis. Another indication for its use includes younger patients in whom the use of anticoagulation is contraindicated. However, with the increasing popularity of minimally invasive valve surgery, and the improved results in valve reoperations, many younger patients choose to have a bioprosthesis. These patients believing that the risk of a second heart operation outweighs the risk of long-term anticoagulation and its associated lifestyle limitations. As a consequence of such factors the tissue valve market has been experiencing strong growth whilst the mechanical valve market appears to have descended into permanent decline. Both types of artificial heart valve markets are, however, being adversely affected by the growing efficiency of heart valve repair technologies.

Valve repair is the procedure of choice for most patients with valve disease as opposed to valve replacement because the long term outcomes are superior with repair. In certain instances, like rheumatic heart disease, the valve is so severely damaged that replacement is performed, but valves can be repaired rather than replaced in 95% of patients and the surgical risk is generally less than 1 in 1,000 and new minimally invasive techniques have the potential to decrease this even further. One such technology is the Monarc system of Edwards Lifesciences for treating mitral valve regurgitation. In April 2007 results from 59 patients implanted with the device revealed a 30-day event-free survival of 91.4%, and no deaths related to the procedure. The Monarc system consists of two stent-like anchors that are connected by a spring bridge, and a biodegradeable element within the bridge. Mounted on a catheter, the device is threaded into the coronary sinus, a vein in the heart that runs next to the annulus, which defines the opening of the mitral valve. The anchors are implanted in separate positions in the coronary sinus, so that the metal bridge surrounds a significant portion of the mitral valve annulus. Over several weeks, the bridge shortens, creating tension around the mitral valve, gradually reshaping the leaflets and surrounding structures, and, thereby, resulting in improved leaflet function and reduced mitral regurgitation.

This report examines the impact of new technologies and the growth of the various sectors of the cardiovascular device market in addition to describing the main geographical markets and the emerging ones such as India, South East Asia, China, which, due to their rapid economic growth are attracting the attention of market players of all sizes. However gaining access to a market with a novel or even a “me too” cardiovascular device is no easy procedure as, in addition to being costly products to reimburse, they frequently fall into the highest of the risk class of devices and the report therefore examines the barriers and procedures required for entering these markets.

For more information visit http://www.researchandmarkets.com/reports/c79403

Source: Informa Healthcare