Types Of Cardiology Devices – Operon Strategist

 

Cardiology Devices comprise one of the largest categories of medical devices by sales. They are second only to in-vitro diagnostic devices. Approximately one out of every ten medical devices made are Cardiology Devices. Ranging from small, implantable devices to large external machines, they are used to diagnose and treat heart diseases and related cardiovascular problems.

Cardiology Devices perform a variety of functions. Some monitor the heart for arrhythmias, sometimes responding with actions to correct irregular beats. Others supplement the heart’s pumping action. Individual valves can be manufactured, as can artificial organs to replace the heart completely. 

Types of Cardiology Devices 

• Implantable Cardioverter Defibrillators

People with advanced heart disease, heart failure and certain genetic arrhythmias are often at risk of life-threatening, fast, irregular heartbeats called ventricular arrhythmias. 

• Pacemakers

There are two kinds of pacemakers. The traditional model is placed under the skin and connects to the heart via electronic leads. A smaller, leadless pacemaker is placed inside the heart and does not require transvenous leads.

• Biventricular Devices

A biventricular pacemaker works like a conventional pacemaker but uses a third wire to send electrical impulses to the heart to resynchronize the contractions of the heart’s left lower chambers, or ventricles.Also called a cardiac resynchronization device, a biventricular pacemaker is implanted when medications don’t relieve symptoms of heart failure, a condition in which the heart does not pump a sufficient amount of blood to the body, and when the left chamber does not beat in a coordinated manner. 

• Implantable Cardiac Loop Recorders

Your cardiac electrophysiologist may recommend implanting a wireless cardiac monitor called a loop recorder. This device continuously records information about your heart’s rhythm for up to three years.

• Standards and Regulations for Cardiology Devices 

• ISO 14708-1:2014 — Active implantable cardiac devices: general requirements for safety, marking, and information to be provided by the manufacturer.
• ISO 14708-2:2012 — Cardiac pacemakers.
• ISO 14708-5:2010 — Circulatory support devices.
• ISO 14708-6:2010 — Particular requirements for active implantable medical devices intended to treat tachyarrhythmia.
• ISO 27185:2012 — Cardiac rhythm management devices, symbols to be used with cardiac rhythm management device labels, and information to be supplied, and 5555general requirements.
• IEC 62304:2006 — Medical device software.

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