FDA-Approved Devices That Help Keep the Heart Beating
Heart disease, also called cardiovascular disease, can have serious consequences. It’s the leading cause of death for men and women in the United States. Medical devices approved by the U.S. Food and Drug Administration (FDA), such as pacemakers and defibrillators, have extended and improved the lives of millions of people living with heart disease.
The FDA evaluates certain devices for safety and effectiveness before they can be marketed to the public. These medical devices include certain devices used to treat cardiovascular disease, cardiovascular conditions, and other related issues. Many of these FDA-approved medical devices can be implanted in a person’s body, while others are used outside the body. Health care providers determine which cardiovascular devices, if any, are best for each patient.
Below are some categories of FDA-approved devices used to treat various cardiovascular issues. Types of heart devices include:
Automated external defibrillators (AEDs): Portable and automatic, these devices are often found in public places and can save lives. They can help restore normal heart rhythm in patients whose hearts suddenly and unexpectedly stop pumping blood, an event called cardiac arrest. AEDs analyze heart rhythm and can help rescuers determine whether a shock is needed to restore a normal heartbeat. These devices are not difficult to use, but training in the use of AEDs is highly recommended. Learn more about AEDs on the FDA’s website.
Cardiac ablation catheters: Long, thin flexible tubes that are threaded into or onto the heart, cardiac ablation catheters treat abnormally rapid heartbeats. They work by modifying small areas of heart tissue that are causing abnormal heart rhythms.
Cardiovascular angioplasty devices: These are long, thin, flexible tubes that are threaded into a heart or other blood vessel to open narrowed or blocked areas. They are intended to improve blood flow to the heart, reduce chest pain, and treat heart attacks.
Cardiac pacemakers: Small and battery-powered, pacemakers are implanted into the body. Used when the heart beats too slowly, they monitor the organ’s electrical impulses and, when needed, deliver electrical stimulation to make it beat at a more appropriate rate.
Implantable cardioverter defibrillators (ICDs): These devices monitor heart rhythms and deliver shocks if dangerously fast rhythms are detected. Many record the heart’s electrical patterns when certain abnormal rhythms occur, allowing doctors to review the patterns.
Prosthetic (artificial) heart valves: Used for replacing diseased or dysfunctional heart valves, which direct blood flow through the heart, these are available in two forms. Mechanical valves are made of man-made materials. The second type, called “bioprosthetic” valves, are made from tissue taken from animals or human cadavers.
Stents: Small, lattice-shaped, metal tubes that are inserted permanently into an artery, stents are intended to help improve blood flow. Some contain drugs that may reduce the chance that arteries will become blocked again.
Ventricular assist devices (VADs): Mechanical pumps that are intended to help weak hearts pump blood effectively, VADs were originally approved for short-term use until donor hearts became available. Some are now approved for long-term therapy in patients with severe heart failure who are not candidates for heart transplants.
When to Seek Medical Help
If you have questions or concerns about your heart, talk to your primary care doctor. If you feel like you’re having a heart attack or other emergency medical issues, immediately call 911.
Know the warning signs and symptoms of a heart attack. The chances of survival are greater when emergency treatment begins quickly.
Sudden cardiac arrest occurs when the heart suddenly and unexpectedly stops pumping blood. If cardiac arrest does occur, rapid treatment with an AED can be life-saving. Defibrillation is a time-sensitive issue. The probability of survival decreases by 7 percent to 10 percent for every minute that a victim stays in a life-threatening arrhythmia.
Emergency first-responders are typically equipped with and trained to use AEDs. AEDs are also often found in public areas, and people with CPR and AED training can use them to help a person in cardiac arrest.
Report Device Problems to the FDA
If you think you had a problem with a device or experienced a side effect related to the use of a device, report the problem through the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.
If you have questions about an AED device or AED accessory, contact the manufacturer. You can also call the FDA Consumer Complaint Coordinator who works with your state; phone numbers are listed online.