Spotlight on Heart Health

by | Feb 16, 2018 | Medical Devices

Posted By: Stephanie Bouzounis, Senior Communications Specialist

February is American Heart Month, according to the American Heart Association. One of the aims of this federally designated month is to raise awareness about cardiovascular disease. The National Institutes of Health’s Heart, Lung, and Blood Institute (NHLBI) has created The Heart Truth program to encourage Americans to get more physical activity.

Types of Cardiac Devices

For those who need a cardiac device, there are several ones out on the market that serve different purposes. New York University’s Langone Health wrote a list giving an overview of the following cardiac devices and the purposes they serve:

  • Pacemaker, a small device that keeps the heart beating at a regular pace;
  • Biventricular pacemaker helps resyncs the heart’s left ventricle;
  • Implantable Cardioverter Defibrillator detects an irregular heartbeat and delivers pulses or a shock to correct the heart rate or rhythm; and
  • Implantable Cardiac Loop Recorder continuously records the heart’s rhythm.


Additionally, the FDA released its list of approved ‘heart devices’:

  • Automated External Defibrillators (AED) restore normal heart rhythm in people whose hearts suddenly stop pumping blood;
  • Cardiac Ablation Catheters are long, thin, flexible tubes threaded into or onto the heart that treat abnormally rapid heartbeats;
  • Cardiovascular angioplasty devices are long, thin, flexible tubes threaded into a heart or blood vessel to open narrowed or blocked areas;
  • Prosthetic (artificial) Heart Valves are used for replacing diseased or dysfunctional heart valves;
  • Stents are small, lattice-shaped metal tubes inserted permanently in an artery to improve blood flow; and
  • Ventricular Assist Devices (VADs) are mechanical pumps that will help weak hearts pump effectively.



Interesting advancements have been made for heart devices. A tiny valve has been produced in order to accommodate babies who have congenital heart disease. A team of three doctors, Henri Justino, M.D., Daniel Harrington, Ph.D., and Kwon Soo Chun, Ph.D., started PolyVascular to change the manufacturing paradigm and produce tiny heart valves in varying sizes. The goal is to create these valves without human or animal tissue. A team at ETH has made a 3D-printed soft heart – a major step toward making a soft, implantable one. And this one actually beats.

FDA Efforts

In its mission to protect the public from potentially harmful products, the U.S. Food and Drug Administration issued a recall in January 2018 of a heart device due to a faulty valve. Johnson & Johnson created the device and issued a recall the previous June. Over 100 Agilis Steerable Introducer Sheath devices manufactured between January 1 and May 5 of 2016 are a part of a Class I Recall – the strictest form of recall issued.

Another major recall issued by the FDA in October 2017 affected St. Jude Hospital patients. The Implantable Cardiac Defibrillator and Cardiac Resynchronization Therapy Defibrillators were recalled to include information about the Battery Performance Alert (BPA), a new battery performance management tool.

Have a question about medical devices or FDA requirements we didn’t answer here? Feel free to contact us at or call (248) 987-4497, or connect with us on LinkedIn, Twitter, and Instagram.

For further reading about medical devices, or how to manage a recall, check out these blogs on our site:

Emma International

Emma International

More Resources

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.

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