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

The 10 Golden Rules for GMP Production – Part 1

The 10 Golden Rules for GMP Production – Part 1

Good Manufacturing Practices (GMP) is a system that consists of processes, procedures and documentation that ensures products are consistently produced and controlled according to set quality standards; for pharmaceutical production this is especially important. In general, there are 10 golden rules that apply in order to fulfill the GMP requirements. This article is part 1 of a 2-part series that discusses the first 5 rules and why they are important.
The eSTAR 510k

The eSTAR 510k

The voluntary eSTAR (electronic Submission Template And Resource) is a fillable portable document format (PDF) document that seeks to make 510(k) and De Novo submissions quicker and easier due to its automation from its form construction and autofill capability
Medical Device Reporting

Medical Device Reporting

Medical device reporting (MDR) is one of the post market surveillance tools used by the FDA to monitor medical devices’ performance post release (21 CFR part 803)

Ready to learn more about working with us?

Pin It on Pinterest

Share This