March 2010

CAPTURING THE BEAT Cardiovascular Diagnosis & Therapy

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With global projected sales worth USD 86.4 billion in 2010, the cardiovascular devices market is one of the most significant segments in the medical technology domain.

Divya Chawla, eHEALTH, attempts to provide an overview of the cardiovascular device industry by estimating the overall market size, reviewing the major market segments, identifying key industry players, evaluating key products and examining new challenges and opportunities.


More than 80 million people worldwide have some form of cardiovascular diseases, as estimated by the American Heart Association. Cardiovascular illnesses, in fact, is one of the leading causes of mortality worldwide, as irrespective of the type of cardiovascular illness most people eventually die of cardiac arrest. Globally, a growing ageing population and increased attention on prevention and diagnosis of cardiovascular diseases have enhanced the focus on cardiovascular devices. In America alone, by 2030, almost 20 percent of the population will constitute of people above 65 years of age. Further opportunities in cardiovascular devices will emerge as a result of emergence of sophisticated, yet user-friendly equipment at affordable rates.

Market Statistics

Cardiovascular devices represents a growing market within the medical technology and equipment segment because of continual increase in the number if people suffering from cardiovascular diseases and conditions. In addition, leading vendors worldwide are focussing more on research and development activities in this domain leading to development of exciting technologically advanced devices and techniques for treatment of cardiovascular diseases and conditions. This will not only guarantee strong revenue growth for the vendors developing these technologies, but also provide enhanced value to the patients as well as the cardiologists.

As per reports, the overall sales in the global market for cardiovascular devices in 2008 amounted to USD 76.7 billion, while the projected sales for 2010 is an estimated USD 86.4 billion. At a compound annual growth rate of 2.8 percent, year 2015 will witness sales of cardiovascular devices to be valued at a phenomenal USD 97.3 billion. Cardiac rhythm management and cardiovascular monitoring and diagnostic devices represent high growth opportunities for the overall cardiovascular devices market. The treatment and diagnosis of cardiovascular diseases have and will provide the requisite impetus for undisputed growth of the overall cardiovascular devices segment. The projected sales of cardiovascular diagnostic devices in 2010 and 2015 are USD 14.1 billion and USD 16 billion, respectively with an estimated CAGR of 2.6 percent.

The major factors driving growth in this market include expansion of indications appropriate for use of cardiovascular devices, development of newer technologies that allow patients to be treated earlier in the disease process, and lack of equally effective other treatment modes.

Key Market Segments

Broadly, cardiovascular devices may be segmented into cardiac rhythm management (CRM) devices and cardiovascular monitoring and diagnostic devices in addition to others.

Cardiac rhythm management (CRM) devices segment comprises of treatment devices for cardiovascular diseases. These include single or dual chamber pacemakers, single or dual chamber implantable cardioverter defibrillators (ICDs), defibrillators and the leads used in cardiovascular pacing and ICD. Almost a decade ago, CRM devices faced several quality concerns, however, the life-saving benefits of CRM devices and development of high quality, feature-packed devices have helped the market regain a positive growth pattern.

The cardiovascular monitoring and diagnostic devices segment comprises of the traditional ECG monitors, ECG stress testing systems, Holter monitoring systems and event monitoring systems. New advancements in this segment are mostly geared towards digital innovations that provide connectivity to PCs and electronic records, bringing some high-tech features into various practice settings. An exciting development is the integration of a wireless option in these devices that enhances their use and productivity.

Apart from these the other major segments in the cardiovascular market space include cardiovascular prosthetic devices, cardiovascular surgery, electrophysiology, interventional cardiology and peripheral vascular devices.

Established and Emerging Players

Cardiovascular devices in India is a dynamic segment with several small and large players who make significant investments and rely on profits generated in, as well as outside India. While some players purely operate in India, there are others who have a global presence with sales, marketing, research and development and/or manufacturing affiliates around the world.

Owing to intense industry competition, smaller players utilize product differentiation strategies rather than reduced pricing methods to maintain their foothold in the market. Unique product promotions and different market strategies allow these vendors to sell their products. Companies focusing on fewer segments tend to develop an expertise in that particular segment and have an edge over companies that offer the entire range of products.

The Road Ahead

The rapidly developing healthcare systems in India provides a huge opportunity for growth of the entire medical equipment industry including the cardiovascular devices segment. The rising healthcare expenditures leading to entry of medical reimbursements and health insurance will lay down a strong foundation for this market in terms of stability and growth. Technological advancements and miniaturization of equipment is further going to add value to products in this domain. However, regulation and stringent USFDA guidelines limit, what could have otherwise been a technological explosion, but at the same time ensure the quality of products penetrating the market. Despite intense competition in the marketplace, growth opportunities exist for participants that meet end-user demands of quality balanced with lower-costs.

The medical device industry is witnessing radical changes and is playing a crucial role in transforming the healthcare delivery system, providing new solutions that will challenge the existing paradigms. Demand in times to come will be driven by devices/technologies that offer higher value in terms of better clinical outcomes, improved quality of life, reduced mortality in critical conditions, ease-of-use for the clinicians, reduced hospitalization and affordability as equated to the life span of an individual.

The focus is increasingly on value of medical technology that is a combination of clinical based outcomes with more contemporary measures of economic efficiency and quality of life. With higher value, the overall cost of treating the disease comes down due to lower hospital stay, faster back to full productivity etc.

The pace of medical innovation is accelerating and technologies that were considered to be part of fiction till recently are already reality today. The next decade and beyond will bring rapid changes in this space. Minimally invasive therapies designed to help patients heal faster, while at the same time they streamline surgical procedures and reduce hospitalization expenses, medical devices which collect patient information, transmit them to doctors miles away and make necessary adjustments in the settings for better control of condition; implantable devices combined with drug therapies that target chronic conditions at their point of origination and miniaturization across many kinds of device technologies to provide advanced therapies are all on the horizon.

At Medtronic, these innovations and many more sit on the brink of not just discovery, but reality. The fact that 2/3rd of our revenue comes from products introduced in last 2 years shows the pace of innovation and commitment towards innovation at Medtronic. Medtronic since its inception has been challenging itself and has been at the forefront of innovation in medical devices across the globe thereby setting newer and higher benchmarks for the industry to follow. Keeping up with the newer emerging needs, some of our path breaking innovations at Medtronic in cardiac space have been MRI compatible pacemaker for arrhythmia patients, devices for Minimally Invasive Cardiac Surgery for CABG, mechanical defibrillators, to name a few.

Implantable Cardioverter Defibrillators

Implantable Cardioverter Defibrillators (ICDs) have been developed and are in use for over 10 years now in India. Batteries used in implantable cardiac pacemakers and defibrillators present unique challenges to the developers and manufacturers in terms of high levels of durability safety and reliability. It is important that the batteries must have longevity (long life) to avoid frequent replacements, repeat procedure & increased costs.

Advantages of having the highest quality of batteries in these implantable devices include reduced device replacement complications for patients, decreased costs of replacement, improved cost-effectiveness, and favourable cost per day comparisons as compared to other therapies.

Medtronic is the only company that manufactures its own batteries for the pacemakers and has been constantly working towards improving on this technology and currently remains a leader in battery technology used in implantable devices. The advantage of in-house battery technology development on the one hand provides the technical and clinical benefits as mentioned above while on the other also enables us to address the aesthetic aspects and requirements of the implant by keeping the size and thickness of the devices very compact while constantly improving on the longevity.

Importantly, we are able to make better estimates and projections of the device longevities as proven by many studies.

Latest products launched MRI compatible pacemaker

Patient care and treatment has reached new dimensions and Medtronic is a company that believes in developing pioneering technologies. For instance – The Enrhythm MRI compatible pacemaker has changed the lives of a large number of patients who need to undergo an MRI scan for diagnosing other ailments. MRI was contraindicated for pacemaker patients until now i.e. patients need to get the pacemakers explanted for getting the MRI done which is a major procedure as it means that besides the pacemeaker, even the leads that are implanted in the heart of patient need to be removed.

Pacemakers are most often implanted in people whose heart rate is so slow that they are in danger of losing consciousness. As a result, millions of patients have implanted pacemakers, and the numbers of new implants have averaged about 225,000 per year over a recent 5-year period (as per US Statistics). In India an average of 20,000 patients get pacemaker implants every year and will now have the option of getting an MRI SAFE PACEMAKER.

Medtronic’s latest V3D range of devices has proprietary features:

  • Shock Reduction
  • Disease Management
  • Therapy Efficacy
  • Remote Patient Care

Medtronic’s Vision 3D portfolio allows physicians to specify the unique feature options needed to meet their patients’ individual needs. These products continue Medtronic’s legacy of leadership in the industry by delivering products based on customer feedback and mounting clinical evidence, including:

  • MVP�, or Managed Ventricular Pacing
  • OptiVol� Fluid Status Monitoring
  • Conexus� Wireless Telemetry
  •  ATP During Charging� 
  • External Defibrillators

As performing manual chest compressions is both difficult and physically demanding, one of the emerging technologies is mechanical compression devices. At Medtronic, the largest medical device company in the world, we offer Mechanical Chest Compression Device “LUCAS� which is an easy-to-use and lightweight device that provides quality chest compressions according to the European Resuscitation Council and American Heart Association Guidelines for CPR (cardiopulmonary resuscitation). It assists rescuers in facilitating the delivery of vital oxygen to the brain and priming the heart for a defibrillation shock in cardiac arrest situations. LUCAS is simple to use, applied within seconds and feasible for use on most cardiac arrest patients. LUCAS is used by firefighters and paramedics on the scene of a cardiac arrest and used by clinical personnel in the emergency departments and cath labs of hospitals.

LUCAS offers the best opportunity for effective CPR by performing consistent and uninterrupted compressions throughout a cardiac arrest. It is designed to deliver uninterrupted compressions at a consistent rate and depth (100 compressions per minute, depth 1.5 to 2 inches) to facilitate the return of spontaneous circulation in cardiac arrest patients.

By ensuring consistent blood flow, LUCAS helps emergency medical responders deliver a more viable candidate for recovery to the Emergency Department.  Furthermore, LUCAS can assist in improving the operations of an emergency response system or hospital by helping to reduce the chaos on the scene and free up staff for other emergencies.

Cardiac Arrest in the Cath Lab are  not uncommon and its difficult to provide manual chest compression and continue fluoroscopy. As  the LUCAS Back Plate and Support Legs are made out of plastic which is radiotranslucent (creates a shadow in x-ray). It allows for continued intervention during CPR,a bridge for LVAD, ECMO, CABG.

LIFEPAK 15 monitor/defibrillator from Medtronic is the new standard in emergency care which is most clinically and operationally innovative and technology advanced device available today.

It has large dual-mode color display, controls and speed dial for ease of use, User Configurable display and features to match customer need, ADAPTIV Biphasic, energy to 360J,Advanced Resuscitation features cprMAX, metronome, IP44 rating�will work in a steady wind and rain storm, harsh environments. IT integrates Masimo Rainbow SET technology that monitors SpO2, Carbon Monoxide and Methemoglobin, includes a metronome to guide CPR compressions and ventilations and provides an option to escalate energy to 360J. An entirely new platform, the 15 is powered by Lithium-ion battery technology, incorporates the SunVue display screen for viewability in bright sunlight, and data connectivity to easily and securely collect and send patient information.

Other products in this category include LP-20, LP-1000 and LP-CR+.

Cardiac Surgery

A significant advancement in the surgical treatment of coronary artery diseases recently has been minimally invasive coronary artery bypass grafting (MICS CABG). Medtronic has recently introduced stabilization and positioning devices for MICS CABG.

Worldwide, approximately 675,000 patients require some form of coronary artery bypass surgery each year.  Coronary Artery Bypass Grafting (CABG) is a surgical procedure that restores blood flow to the portion of the heart that has blocked arteries.  Using other arteries or veins from your body, the procedure involves attaching these vessels or grafts to the heart in order to reroute the blood around the blockage, creating an alternative pathway for blood to reach the heart muscle that is not receiving sufficient bloodflow.

Growing number of patients in developed countries are receiving minimally invasive CABG procedures or MICS CABG.  This minimally invasive procedure does not require cutting of chest bone (sternotomy); instead the operation is performed through a 5-7 cm under the left breast.

The potential benefits of the MICS CABG procedure include reduced hospital stay, faster recovery, invisible surgical scar, and greater satisfaction to the patient and his physician.

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