E-Articles - Health and Fitness

The heart is a wonderful creation, designed to pump blood through the body 24/7/365 and Leap Year 366. Awake or asleep, humans depend on the heart to do its work. No one ever consciously directs that work. The heart operates without

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

conscious decision or effort.

Heart valve disease can hinder that operation, however. Heart valves are strong, thin flaps of tissue that open and close to allow blood to flow properly through the heart. As the heart pumps, the val

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

es stretch back and forth, keeping blood flowing in the right direction. They work hard, moving with each beat of the heart.

Heart Valve Disease

Heart valve disease may cause the valves not to open enough to let blood flow

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

reely. Or the opposite may happen – valves may not close as completely as they should, and blood leaks between chambers when it should not. Heart valve disease causes the heart to work harder. This may lead to heart failure.

Heart

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

alve disease can be present at birth, and silently can cause problems as the child grows. Heart valve disease might also be caused later in life by infections, heart attacks, heart damage, or other heart disease.

Sometimes, heart v

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

lve disease is minor. No treatment is necessary for minor problems. Other times, heart valve disease might require prescription drugs or a medical procedure. Surgery may be recommended to repair or replace the problem valve.

Hea

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

rt Valve Surgery

Heart valve surgery may be used in one of two ways. The surgeon may repair a valve, or take it out entirely and replace it with an artificial valve.

Mitral valves can usually be repaired and left where they ar

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

. Aortic valves usually must be replaced with artificial valves.

Once the cardiologist and patient have reached a decision to proceed with surgery, they will need to consider options as to which kind of artificial valve will be use

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

: biological or mechanical.

1. Biological valves: Biological heart valves are those made from humans or animals. These valves are often made from pig aortic valves. Some have been made from cow tissues.

2. Mechanical valves: Mecha

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ical heart valves are made of metal, plastic, and pyrolytic carbon. They are very strong, and will usually last a lifetime.

Heart Valve Surgery Complications

Heart valve surgery complications can occur. Usually these proble

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

s are linked to the type of artificial valve used. Although there is little difference among valve types as far as the patient is concerned, surgeons often prefer one over another because of the way it is sewn into place.

Heart val

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ve surgery complications that you will want to discuss with your cardiologist include, but may not be limited to the following.

1. Blood clots tend to form on all mechanical valves. The risk of these blood clots causing a stroke in

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

the patient is small, but definite. To counteract the blood clot risk, patients are required to take blood thinners for the rest of their lives. Blood thinners are usually safe, but they can increase bleeding within the body. If tha

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

bleeding occurs in the brain, it can lead to death.

2. Blood clots sometimes form on biological valves as well, but the risk is greatly reduced. Patients take anticoagulants for only 6 weeks to 3 months. The main problem with thes

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

artificial valves is that they eventually wear out and must be replaced. Their expected life is 10 to 15 years, so a young person might have to have several replacements.

3. Anesthesia and the rerouting of your blood through a byp

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ss machine may cause heart valve surgery complications such as arrhythmia, pneumonia, kidney failure, stroke, and death.

4. Blood clots are another complication that may result from heart valve surgery. These usually show up a few

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

days after surgery, causing pain and swelling in the leg or legs affected. If a blood clot is dislodged from the leg, it can travel to the lungs and cause shortness of breath, chest pain, or even death.

5. Other heart valve surgery

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

complications are: bleeding during or after surgery that may require a blood transfusion; infection in the chest incision; and deep infections in the heart or the breastbone.

6. The new valve may malfunction shortly after surgery o

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

much later, requiring emergency surgery. This is rare, but can result in death.

7. Arrhythmia (abnormal heartbeats) may occur after heart valve surgery. These are controlled by medication. They usually stop after a few days or wee

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

s, but some become permanent.

CAUTION: The author is not a medical professional, and offers the information in this article for educational purposes only. Please discuss it with your physician before relying on it in any way

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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