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8 types of FDA-approved devices that treat the heart

February 13, 2020 By Chris Newmarker

FDA-approved devices for treating the heart cardiology

[Image courtesy of FDA]

Just starting to learn about all of the medical devices out there for treating cardiovascular diseases? The U.S. FDA has a good, basic roundup on its website of the most common types of cardiovascular devices it regulates.

Here’s the list, along with the FDA’s descriptions:

1. 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.”

2. 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.”

3. 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.”

Medtronic Micra medical device miniaturization

Medtronic’s Micra leadless pacing system [Image courtesy of Medtronic]

4. 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.”

5. 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.”

Edwards Sapien 3 Ultra TAVR

Edwards Lifesciences’ Sapien 3 Ultra TAVR [Image courtesy of Edwards Lifesciences]

6. 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.”

7. 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.”

8. 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.”

About The Author

Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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