Market & Competition
Market Size
Heart failure is a major cause of death throughout the world, and is associated with a high rate of morbidity and a lower quality of life than that of patients suffering from any other chronic disease. More than 10 million people suffer from heart failure worldwide. In the US alone, approximately 5 million people suffer from heart failure with more than 500,000 new diagnoses each year. Approximately 10% of heart failure patients, approximately 1 million, are at the end stage of the condition; these patients are considered Class IV heart failure patients per the New York Heart Association guidelines. HeartWare® estimates that each year approximately 100,000 Class IV patients worldwide might benefit from a left ventricular assist device (LVAD), such as the HeartWare® Ventricular Assist Device (HVADTM). The market for LVADs is increasing enormously each year, at a compound annual growth rate of 29.6% for 2010-2015, details in Table 1.
LVADS are used for two primary purposes when treating heart failure patients: bridge-to-transplant therapy (BTT) and destination therapy (DT). BTT refers to the temporary use of an LVAD while awaiting transplantation, whereas DT refers to the permanent or quasi-permanent use of an LVAD. While BTT patients account for the vast majority of the currently treated population, DT is the long-term goal and accounts for the majority of the prospective market. As such, HeartWare®'s primary emphasis is on DT; however, regulatory approval for BTT is an important interim step.
It is estimated that the market for heart failure patients worldwide who do not qualify for transplantation and would require destination therapy is as large 100,000 new patients annually. The ev...
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...s based upon the same principles as the MVAD™ but marketed towards pediatrics.
In addition to improving ventricular assist pumps, HeartWare® is also looking to improve its electronic products. It is currently working towards designing a prototype for an implanted controller, through the means of a Transcutaneous Energy Transfer System (TETS). 17 The goal is to successfully implant a battery and controller pack in the patient to eliminate connecting the pump to external electronics. The implanted TETS pack would be recharged via induction across the skin. 17 The TETS platform would eliminate the need for the external driveline, and consequently reduce the risk of infection caused by the driveline. These products in development aim to treat more heart failure patients while also providing more comfort and convenience to those who currently use a HeartWare® pump.
Transcatheter aortic valve replacement or TAVR is the latest technology used principally for the treatment of aortic stenosis, a condition in which one of the major valves of the heart, the aortic valve, becomes tight and stiff, usually as a result of aging (3). Since many patients who need aortic valve replacement for aortic stenosis are too sick to undergo major valve replacement surgery, they are unable to get the treatment they need. With the transcatheter aortic valve, this issue is bypassed because this valve can be implanted in the heart by accessing the patient’s heart through an artery in the groin. The valve can be inserted through a wire that can be pushed to the heart and the old valve is simply pushed to the side when the new valve is implanted. This technology has been in use in the US with Edwards’ Sapiens valve since 2011 and has saved the lives of many patients with aortic stenosis (4). Medtronic’s CoreValve uses similar technology and has won patent fights in Europe and has been in use internationally. However, within U.S., Medtronic has not been...
Heart disease is the leading cause of death in the United States and the estimated cost of treatment is $32 billion yearly. Approximately 5 million people living in the United States suffer from congestive heart failure (CHF) and half of those diagnosed will die within 5 years. An individual may present to the hospital with weakness, short of breath (SOB), swelling of the extremities, ascites, and breathing difficulties while lying down. The quality and length of life for someone suffering from heart failure can be improved with early diagnosis, medication, physical activity, and diet modification (CDC, 2013).
Takeda A, Taylor SJC, Taylor RS, Khan F, Krum H, Underwood M. (2012). Clinical service organisation for heart failure (Review). Cochrane Database of Systematic Reviews. Issue 9. Art. No.: CD002752. DOI: 10.1002/14651858.CD002752.pub3.
The Burden of the disease is high with a prevalence of 3.4% 2. With the progressive nature of the disease and the increased severity of the symptoms made the surgery the gold standard for symptomatic AS patients ,however up to 30% of cases are considered too high risk for classical valve replacement surgery and remain untreated and experiencing poor prognosis . Fortunately , with the introduction of TAVR its offer a valuable option for the inoperable or at high risk of surgery patients3..the annual eligible candidate for this procedure expected to be 27,000 in 19 European countries and North America according to recent meta-analysis an...
My clinical rotation for NURN 236 is unique in that all patients I care for at Union Memorial Hospital in Baltimore, Maryland have a diagnosis of heart failure (HF). HF occurs when the heart is unable to pump adequate blood supply, resulting in insufficient oxygen and nutrients to the tissues of the body (Smeltzer, Bare, Hinkle, and Cheever, 2012). Approximately 670,000 Americans are diagnosed with HF each year and is the most common hospital discharge diagnosis among the elderly (Simpson, 2014). Moreover, according to the Centers for Medicare and Medicaid Services (CMS), HF is the leading cause of 30-day hospital readmission followed by acute myocardial infarction (AMI) and pneumonia (medicare.gov|Hospital Compare, 2013). This information along with my weekly HF patient cohort prompted my curiosity regarding impacts of HF readmissions, factors of HF readmission, and to compare suggested evidence based practice with policies utilized at Union Memorial for reducing the 30-day readmission rate for HF.
They have now invented a “beating heart transplant.” It consists of a mechanical system to keep the heart beating, while it is being transferred to the candidate. Statistics have proven that these candidates have a higher recovery rate, because of the “beating heart.” Throughout reading above, it is a given that organ donation is vital to saving lives, but it is not deemed proper to be made mandatory.
Congestive Heart Failure is when the heart's pumping power is weaker than normal. It does not mean the heart has stopped working. Blood moves through the heart and body at a slower rate, and pressure in the heart increases. This means the heart cannot pump enough oxygen and nutrients to meet the body's needs. The chambers of the heart respond by stretching to hold more blood to pump through the body, or by becoming more stiff and thickened.
Heart failure is a major clinical, social and economic problem in the United Kingdom according to the Department of Health [DH] (2013).The National Institute for Health and Clinical Excellence [NICE] (2010) reported that about 900,000 people suffer from heart failure in the United Kingdom. The National Institute for Cardiovascular Outcomes Research [NICOR] (2011) conducted a national audit which found that one in every 20 people over the age of 65 is diagnosed with heart failure which demonstrates that it mainly affects the elderly. As a leading cause of mortality, heart failure contributes to more than 6,000 deaths each year (NICOR, 2011). Newly diagnosed cases of heart failure have a 40% risk of dying within a year (NICOR, 2011). Despite advances in therapy, mortality is still high and only half of patients are alive five years after being diagnosed with heart failure (NICE, 2010).
...rtinelli, M., Moroni, D., & Salvetti, O. (2010). Decision support in heart failure through processing of electro- and echocardiograms. Artificial Intelligence in Medicine, 2010-10-01, Volume 50, Issue 2, 95-104.
Moisse, Katie. “Stem Cells: New Hope for Heart Failure Patients”. Abcnews.com. 14 Nov 2011. Web. 15 Nov 2011.
left ventricular function and heart failure.” Clinical Investigative Medicine. 31.2 (2008): E90-E97. Web. 15 Feb. 2014.
Each and every day there are as many as 79 people receiving organ donations that will change their life, but on the other hand there are many people who die from failed organs while they are waiting for transplants that never happen for them (U.S. Department of Health & Human Services, 2016). People find out that one, or even several of their organs are failing and they are put on a list to receive a transplant with no intended time frame or guarantee. Organ transplants are an essential tool when it comes to saving someone’s life from a failing organ; the history of organ transplants, organ donation, and the preceding factors of organ failure all play a very important role in organ transplant in the United States.
With this newer technology Physicians, nurses, and other approved medical staff have the option to monitor their patient’s heart functionality, and fix pacemaker electrical signals to fit patients need from a mobile device, without ever bringing the patient into the Physicians’ office. Cardiac remote patient monitoring uses smart phones, and specific designed (secured) e-mails to deliver information sent from the device implanted within the patient’s heart. This allows medical staff to receive pertinent up-to date- information on the condition of the patient’s pacemaker, and heart. This can help create profound patient care, early critical heart failure, or heart defibrillation detection; while adding to medical staff’s proficiency, and cutting costly emergency room visits with prevention detection ("Remote Monitoring Technology Improves Pacemaker Performance", 2012).
“Despite worldwide softness in the sale of luxury goods, LVMH has cemented its position as the world’s largest and most profitable player in the category. To stay there it must keep its customers loyal and its brand strong and find new markets worldwide” (Hazlett C. 2004). That is why in its mission they state to represent the most refined qualities of Western “ art de vivre” all around the world. Their objective is to be the leader in the luxury market, continuing to transmit elegance and creativity. This poses some major challenges, the main one is to keep being the leader in the luxury market through a sustainable growth. The main problem to achieve it is the high dependency on three main countries, France, Japan and USA. This becomes a threat because if there is an economic downturn in one country it affects LVMH directly that is why.
We have started utilizing many devices, applications on smart phones to help us with diagnosing and capturing important information regarding patient’s disease. Livecor, a mobile electrocardiogram enable patient to capture their heart rhythm at the finger tips. All patients have to do is to place their fingers tips at the back of a smart phone such as an iPhone with the Livecor case attached to the phone. The patient’s rhythm will show up on the smart phone screen, if patients are having palpitations, they can easily use this technology to detect abnormal cardiac rhythms, and with a charge of fees, they can have the rhythm being reviewed and interpreted by a certificated cardiologist and obtain an official report. Technology like this prevents unnecessary emergency room visits and decrease hospital admissions, which overall decrease health care