Aorta Aneurysm

Implantica’s Solution, AneurysmControl™

Implantica’s AneurysmControl™ is subject to further development and approval process. An aortic aneurysm is an abnormal bulge that occurs in the wall of the major blood vessel (aorta) that carries blood from your heart to your body. It affects more men than women and up to 8% of men above 60 years old¹. Larger aortic aneurysms could suddenly start to expand and burst, with potentially deadly consequences. More people die from this disease than from car accidents, in the US the magnitude of 28’000 people died from this disease in 2009. Therefore, a large screening program has been started all over the world. Due to the high-risk surgery only the largest sizes above 5,5 cm are operated, which is about 15% of the patients found during the screening process.

AneurysmControl™ is expected to save lifes by monitoring the expansion of the aneurysm.

Implantica’s AneurysmControl™ is designed to be a preventive method to control and treat the aneurysm in the remaining 80% of the patients, with the expected result that emergency operations and sudden deaths can be avoided.

Patients not operated are followed by ultrasound investigation every 3-6 months. AneurysmControl™  is designed to continuously monitor the aneurysm, estimated to make regular, costly and time consuming ultrasonography unnecessary, which is the current standard monitoring approach following the detection of an aneurysm. In addition, currently only later-stage aneurysms can be treated, whereas AneurysmControl™  is designed to be able to treat and monitor aneurysms at any stage.

AneurysmControl™ is expected to treat and monitor up to 80% of the patients identified as at risk through worldwide screening programs.

The innovative solution uses a pressure-calibrated hydraulic cuff, which is designed to help to slow down or prevent further expansion of the aneurysm. At the same time, the device is designed to monitor the change in size of the aneurysm to inform the Patient and the Caregiver – a novel and important feature. The hydraulic system is designed to exert constant light pressure against the aneurysm and is able to increase the pressure automatically if expansion should occur. AneurysmControl™ is designed to also prevent further expansion of the aneurysm as well as monitor it, to avoid both future aneurysm rupture with high risk of death and later highly risky surgery.

Benefits of AneurysmControl™

Prevents rupture of the aneurysm

AneurysmControl™ is designed to protect a growing aneurysm from rupture with a hydraulic support.

Continuous monitoring

AneurysmControl™ is designed to continuously monitor the growth of the aneurysm, thereby reducing patient risk. If an aneurysm would start to expand the smart implant is designed to automatically increase the contra pressure on the aneurysm to avoid self expansion and death.

Enables treatment of early stage aneurysms

Because of the increased use of ultrasound screening of patients at risk of developing aortic aneurysm, it will be possible to identify patients in an early stage of the disease. AneurysmControl™ is targeting to be the only product on the market to treat this group of patients.

Early protection proven beneficial

The large number of deaths caused by Aorta aneurysm motivates use of early protection implants such as AneurysmControl™ . Benefits of early protection and monitoring of the aneurysm to avoid self-expansion and bursting aneurysms causing deaths, outweigh the risks associated with a surgical procedure.

Field Description

An aneurysm is an abnormal bulging or swelling of a portion of a blood vessel. The aorta, which can develop these abnormal bulges, is the large blood vessel that carries oxygen-rich blood away from the heart to the rest of the body. Aorta aneurysm usually occurs in the abdomen below the kidneys (abdominal aortic aneurysm) but may occur in the chest cavity (thoracic aortic aneurysm).

Aorta aneurysm falls under the broader term cardiovascular disease which is used to describe a range of diseases that affect the heart and blood vessels of the human circulatory system. If untreated, an aneurysm may rupture, resulting in internal bleeding. A large rupture may be rapidly fatal. In order to prevent deaths, large screening programs have started all over the world to find specifically aortic aneurysms. These aneurysms cause more deaths than traffic accidents.

As mentioned abdominal aortic aneurysm is found in up to 8% of men¹ more than 60 years old, and while it is less common among women, studies have shown that women have a worse prognosis than men.

1. 1Fleming et al., 2005.

Existing Treatments

Currently, early stage aneurysms often go untreated. Instead, small aneurysms are monitored for their rate of growth and only large aneurysms are treated.

Small aneurysms are deemed small when the risk of repair exceeds the risk of rupture, usually aneurysms with a diameter of less than 5 cm. Today, these are monitored by performing ultrasonography every 3 to 6 months.

When an abdominal aortic aneurysm, the most common form of aneurysm, is judged to be large enough to carry risk of rupture, there are two types of surgery performed, however, due to high risk only considered for about the 15% of the patients with the largest aneurysms. However, also smaller aneurysm could start to self expand and rupture. It does not fully help to perform an ultrasound every 3-6 months when an expansion could occur very rapidly anytime, however, no other treatment exists today.  Therefore AneurysmControlTM has been designed to save lives and monitor the aneurysms not operated.

The two prevailing surgical solutions today is replacing the aneurysm with an artificial blood vessel using a synthetic graft to repair the aneurysm and endovascular repair (EVar) using a large metal stent to place inside the aneurysm in the blood vessel. Both these procedures carries high risk and is only used for the largest aneurysms. The risk of death during an emergency repair of a ruptured aneurysm is about 50%².

1. 2Merck, 2008.

Detailed Treatment Field Information

Cardiovascular disease (CVD) is a broad term used to describe a range of diseases that affect the heart and blood vessels of the human circulatory system. The various diseases or conditions that fall under the description of cardiovascular disease include coronary heart disease (heart attack), hypertension (high blood pressure), stroke, heart failure, and rheumatic heart disease. An estimated 17 million people globally die of cardiovascular diseases, particularly heart attacks and strokes, every year (WHO, 2008). A substantial proportion of these deaths can be attributed to tobacco smoking, physical inactivity and unhealthy diet. At least 20 million people survive heart attacks and strokes every year, a significant proportion of them requiring costly clinical care, which puts a huge burden on long-term care resources.

While the term cardiovascular disease technically refers to any disease that affects the cardiovascular system, it is usually used to refer to those related to atherosclerosis (hardening of the arteries) or arterial disease. These conditions have similar causes, mechanisms and treatments. By the time these problems are detected, the underlying cause is usually quite advanced, having progressed often for decades.

Treatment of cardiovascular disease depends on the specific form of the disease in each patient, but effective treatment always includes preventive lifestyle changes. Medication, such as blood pressure reducing medication, anticoagulants such as aspirin, and cholesterol-lowering pharmaceuticals, may be helpful. Surgery or angioplasty may be warranted to reopen, repair or replace damaged blood vessels.

Implantica is developing new technology which will allow the treatment of aortic aneurysm.

Overview

Aortic aneurysm. An aneurysm is an abnormal bulging or swelling of a portion of a blood vessel. The aorta, which can develop these abnormal bulges, is the large blood vessel that carries oxygen-rich blood away from the heart to the rest of the body. Aortic aneurysm usually occur in the abdomen below the kidneys (abdominal aortic aneurysm or AAA), but may occur in the chest cavity (thoracic aortic aneurysm or TAA). This can happen if the wall of the aorta becomes weakened by build ups of fatty deposits called plaque. This is called atherosclerosis.

Description and definition

Aortic aneurysm

The aorta extends upward from top of the left ventricle of the heart in the chest area (ascending thoracic aorta), then curves (aortic arch) downward through the chest area (descending thoracic aorta) into the abdomen (abdominal aorta). The aorta delivers oxygenated blood pumped from the heart to the rest of the body.

Aortic aneurysm can develop anywhere in the aorta. The more common form of aortic aneurysm is abdominal aortic aneurysm (AAA) that is a localized dilatation (bulge) of the abdominal aorta that exceeds the normal diameter by more than 50%. The normal diameter of infrarenal aorta is 2 cm. Aneurysm is caused by a degenerative process of the aortic wall most commonly located infrarenally. The pressure of blood inside the artery forces the weak area to balloon outward. If untreated, an aneurysm may rupture, resulting in internal bleeding. A large rupture may be rapidly fatal. The aneurysm can extend to include one or both of the iliac arteries. The less common form of aortic aneurysm, thoracic aortic aneurysm (TAA), is aneurysms in the part of the aorta that passes through the chest (thorax). About 25% of patients with TAA also have AAA (Nelson, 2006).

AAA is less common in women than in men, but there is evidence that women with AAA have a worse prognosis (Norman, 2007). AAA is found in 4% to 8% of older men and 0.5% to 1.5% of older women (Fleming et al., 2005).

Causes and effects

By the time that the problems associated with a cardiovascular disease become apparent, the underlying cause may have been active for many years and may be quite advanced. Vascular injury accumulates from adolescence, making primary prevention efforts necessary from childhood.

There are many factors which increase the risk of cardiovascular disease. The major causes are tobacco use, physical inactivity, and unhealthy diet. High blood pressure, high blood cholesterol, obesity, and the chronic disease of type 2 diabetes are among the major biological risks.

Aortic aneurysm

The major risk factors and causes of aortic aneurysm are:

• Genetic influences. The influences of genetic factors are highly probable, most notable in male individuals.
• Lifestyle influences. Smoking, alcohol consumption, high fat/cholesterol diet and stress leading to high blood pressure are all believed to increase the risk.
• High blood pressure.
• Atherosclerosis. The wall of the aorta becomes weakened by build ups of fatty deposits called plaque.
• Injury to the chest.
• Hemodynamic influences. Abdominal aortic aneurysm is a focal degenerative process with predilection for the sub renal aorta. The elasticity of the arteries decline with age and this can result in gradual dilatation of the segment. Higher intraluminal pressure in patients with arterial hypertension contributes to the progression of the pathological process.

Thoracic aortic aneurysms do not usually produce any noticeable symptoms. However, as the aneurysm becomes larger, chest, shoulder, neck, lower back, or abdominal pain can result. Abdominal aortic aneurysms cause pain in the lower back, hips, and abdomen. A painful abdominal aortic aneurysm usually means that the aneurysm could rupture very soon.

Aortic aneurysms are potentially life-threatening conditions. If the aneurysm is untreated and eventually ruptures, it can lead to death.

Existing treatments

Aortic aneurysm

Small aneurysms should be monitored for their rate of growth and large aneurysms require consideration for a surgical repair.

The treatment options for the more common form of aneurysm, abdominal aortic aneurysm (AAA), are employed in accordance to their different indications:

• Conservative treatment is indicated in patients where repair carries a high risk of mortality and also in patients where repair is unlikely to improve life expectancy. The two mainstays of the conservative treatment are smoking cessation and blood pressure control.
• Surveillance is indicated in small aneurysms, where the risk of repair exceeds the risk of rupture. Although some controversy exists around the world, most vascular surgeons would not consider repair until the aneurysm reaches a diameter of 5 cm. If an aneurysm is detected, ultrasonography is done to estimate the rate of enlargement and determine when repair will be necessary. Procedures are done every 3 to 6 months.
• Open repair (operation) is indicated in young patients as an elective procedure, or in growing or large, symptomatic or ruptured aneurysm. Surgery consists of inserting a synthetic graft to repair the aneurysm. The risk of death during an emergency repair of a ruptured aneurysm is about 50% (Merck, 2008).
• Endovascular repair (EVAR) is generally indicated in older, high risk patients or patients unfit for open repair. EVAR is less invasive approach than open surgery. In EVAR, mostly stented grafts are used and placed in the aneurismal area of the aorta. Endovascular repair is feasible for only a proportion of abdominal aortic aneurysms, depending on the morphology of the aneurysm. The EVAR procedure does not offer any overall survival benefit but has a lower operative mortality with unruptured aneurysms. The cost for the EVAR procedure is higher than for open surgery. (Lundgren, 2007 et al.)

The treatments for the less common form of aneurysm, thoracic aortic aneurysm (TAA), are:

• Open surgery. Traditional treatment of diseases of the thoracic aorta has involved high-risk surgery requiring a large incision in the chest to place a synthetic graft to repair the diseased artery. This method can result in long hospital stays and painful recoveries.
• Endovascular repair.

There may be complications following aneurysm surgical procedures. Less serious complications that may follow include swelling, respiratory or urinary infections, or infections at the incision site. More serious complications include sexual dysfunction, spinal cord stroke, heart problems, breathing problems, kidney problems, and colon problems. Paralysis in the lower half of the body is very rare following AAA surgery but can occur more commonly following extensive TAA operations.

Socio-economic burden

As knowledge increases about the prevalence of vascular disorders, health care providers and government leaders have become more aware of the economic burden of these conditions. In addition to the negative impact on the quality of life of the sufferer, disorders such as renovascular hypertension, abdominal aortic aneurysm and the risk for embolism, impose financial burdens on many levels of society:

• Costs of healthcare services and medication.
• Loss of income.
• Non-productivity in the household, and in the overall economy.
• Job absenteeism and disruption in the workplace.
• Financial burden on family, friends and employers.
• Worker compensation costs and welfare payments.

Cardiovascular-related disease generates more healthcare costs and lost income than most other therapeutic areas. The cost is accelerating as the population ages and expands, creating unprecedented demand for new effective treatments that prevent, delay and cure vascular-related illnesses.

The Council of Ministers of the European Union (EU) has emphasized that cardiovascular disease (CVD) is the largest cause of sickness and morbidity and a major cause of death and premature death as well as reduced quality of life for the citizens of the EU. Each year CVD causes over 4.3 million deaths in Europe and over 2 million in EU (EHN, 2008). CVD cost EU healthcare systems approximately EUR 105 billion (USD 132 billion; rate 1.2557 in 31/12/03) in 2003, with this expenditure accounting for 12% of total healthcare expenditure in EU. CVD represented an annual healthcare cost of EUR 230 (USD 289) per EU citizen. Overall, CVD is estimated to have cost EU economy EUR 169 billion (USD 212 billion) in 2003. Germany and the UK represented over half (54%) of all CVD costs. (Leal et al., 2005) The cost has increase over the years. In 2008, overall CVD cost is estimated to cost EU economy EUR 192 billion (USD 282 billion; rate 1.47038 in 01/01/08) a year. Around 57% of the cost is due to health care costs, 21% due to productivity losses, and 22% due to informal care of people with CVD. (EHN, 2008)

In the United States, cardiovascular disease has become one of the most costly illnesses. The cost of CVD and stroke in the US in 2008 is estimated to be approximately USD 449 billion, according to the American Heart Association (2008) and the National Heart, Lung, and Blood Institute (NHLBI). This figure includes both direct and indirect costs. Direct costs include the cost of physicians and other professionals, hospital and nursing home services, the cost of medications, home health care and other medical durables. Indirect costs include lost productivity that results from illness and death. (American Heart Association, 2008)

Implanted medical devices are gaining increasing utility in the treatment of cardiovascular patients and have the potential to revolutionize treatment. Cost benefit analysis show that medical implants compared with pharmaceutical treatment are cost effective despite high initial costs. Cardiovascular medical implants are included in the reimbursement system.

Field conclusion

Cardiovascular disease can lead to aortic aneurysm, a significant and life-threatening condition. Implantica is developing new technologies which will be used in the treatment of this condition. AneurysmControl™ is designed to provide increased life expectancy and decreased mortality. The patient is expected to achieve increased quality of life.