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FDA Approves Implantable Heart Device

The FDA has approved a new implantable device for the heart that could bring relief to more than half a million people with congestive heart failure. Dr. Emily Senay is here with more.

How does the device work?

Some people with advanced congestive heart failure can eventually reach a stage where the two chambers of their heart are so weak, that they are not beating with the normal simultaneous rhythm needed for proper function and full strength.

The new device is called the INSYNC System, and it resynchronizes the heartbeat to return some of that strength. Although it looks exactly like a pacemaker, and it delivers electrical impulses to the heart like a pacemaker, the actual job it’s performing is quite different.

The device has three wires that are attached to the weakened heart. Two of the devices are connected to the right pumping chamber and one is threaded through to attach to the left pumping chamber. Once in place, electrical impulses resynchronize the pumping action of the lower chambers of the heart.

That resynchronization gives each heartbeat an extra boost to improve the overall function of the heart.

Who is this device good for?

The device will help people with congestive heart failure who are not responding to any other treatments. Patients with heart failure deteriorate to the point where they are in pretty bad shape, either bedded down or unable to walk even a few steps. Studies have been done that show this new device improves their situation, in some cases quite dramatically. People could walk much further and said that they felt much better.

Is this good for everybody with advanced heart failure?

No, this device won’t help everybody. The studies looked at very severe heart failure with people who developed a weakened heart where the muscle itself is weak. The results were very promising, but there are different kinds of heart failure. Some people develop stiffened heart tissue and this device will not help them. The technology is still in the early stages, but there is good reason to be enthusiastic about the results.

Does this device allow people to live longer?

That is not clear, because the studies didn’t look at that. But some patients have had the device for up to 3 years, and what they are finding is that it is actually improving the condition of the heart. It’s not clear as to exactly why yet.

Is there a cure for heart failure?

No, you still have to take your medicine.

Is the deviceavailable?

The device is available right now, but it may take some time to train doctors to perform the operation since it requires three leads attached to the heart instead of one or two with standard pacemakers. Six hundred centers in the US and Canada will initially be geared up to implant the device.

Is it covered by insurance?It is more expensive than a typical pacemaker, about $11,00, but it is expected to be covered by insurance.
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