Top FDA Approved Devices That Keep the Heart Beating

Top FDA Approved Devices That Keep the Heart Beating

A pacemaker is the first thing that springs to most people’s minds when it comes to devices for the treatment of heart disease, but a variety of other devices have extended and improved the lives of heart disease sufferers worldwide.

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Giving the Heart a Helping Hand

Cardiovascular disease, more commonly known as heart disease, is currently the leading cause of death in the United States for both men and women according to the Center for Disease Control and Prevention, and is the number one cause of death worldwide according to World Health Organisation statistics.

Types of Device

Internal devices used to treat cardiovascular problems include the following:

– Cardiac pacemakers: These are small battery-powered devices which are implanted into the body permanently. Pacemakers deliver electrical stimulation when the heart is beating too slowly.
– Implantable cardioverter defibrillators (ICDs): These deliver shocks if the heart begins to beat dangerously fast.
– Cardiac ablation catheters: Used to correct abnormally rapid heartbeats, these are thin flexible tubes which are threaded into or on to the heart.
– Cardiovascular angioplasty devices: These help to treat heart attacks and chest pain by improving blood flow to the heart.
– Prosthetic heart valves: These are used to replace diseased or non-functional heart valves and can be made from man-made materials or from human or animal tissue.
– Stents: These are small, lattice-shaped metal tubes, sometimes containing drugs to reduce the likelihood of the arteries becoming blocked. They are inserted permanently into an artery and help to improve blood flow.
– Ventricular assist devices (VADs): These help weak hearts to pump blood more effectively and can be used for long-term therapy in patients who are not good candidates for heart transplants.

Before any medical device can be marketed in the US, an FDA 510k clearance submission must be submitted by the manufacturer in order for the device to be approved. To speed things along, these submissions are often fast-tracked by organisations such as

As an alternative to internal devices, an automated external defibrillator (AED) can be fitted. These are portable devices which help to restore normal heart rhythm in patients who are at risk of cardiac arrest, and can help to determine whether a shock is needed to restore a normal heartbeat.

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