Today’s medical devices for the heart save lives every day. For patients whose hearts beat too slowly or too quickly, or who are awaiting heart transplants, heart medical devices can work miracles. These devices are designed to meet strict medical compliance in order to take over where patients’ hearts lack the capability to keep them alive. There have been many scientific breakthroughs in this field, culminating into devices that help the heart perform such functions as pumping blood and keeping a regular beat. Cardiac pacemakers, defibrillators, assist devices, angioplasty devices, stents, prosthetic heart valves, ablation catheters … these are all wonders of modern medical science. Additionally, the medical device compliance regulations that oversee this part of the medical field are a vital. They are an important component of an industry that exists to improve the quality of life for residents of the entire nation.
Cardiac pacemaker
These are small, battery-powered devices that are implanted into the body when the heart’s natural rhythm becomes defective, causing the heart to either beat too quickly, too slowly, or irregularly. Pacemakers monitor the heart’s rhythm and assist it in beating at a regular pace. They do this through wires that are implanted into the heart’s tissue to send electrical impulses that help the heart beat regularly.
Implantable cardioverter defibrillator
Also referred to ‘ICD,’ this device is used in patients who are at risk for recurrent, sustained ventricular tachycardia or fibrillation, which is a fast rhythm that lasts for more than one minute and requires medical intervention to bring it back to normal rhythm. ICDs monitor heart rhythms and restore the heart to normal pace if dangerous rhythms are detected, often preventing sudden cardiac death. Newer models can even record the heart’s electrical patterns and transmit the information back to doctors.
Ventricular assist device
This is a mechanical pump that assists weak hearts in pumping blood adequately. Often called a ‘bridge to transplant,’ the ‘VAD’ (or ‘LVAD,’ for left ventricular assist device) can be used in patients who are awaiting the availability of a donor heart. These devices are now even used as long-term therapy for patients who have severe heart failure, but are not considered heart transplant candidates. This device, in essence, buys time for the patient until they can receive a transplant. VADs can sometimes even eliminate the need for transplant.
Cardiac angioplasty device
Angioplasty devices are thin, flexible tubes that are threaded into the heart’s blood vessel in order to open areas that have been narrowed by blockage. These are designed to improve blood flow to the heart and even to treat heart attacks.
Stents
These are small, metal tubes that are inserted into an artery in order to improve blood flow. Some stents even contain drugs that help to reduce the chances of arteries becoming blocked in the future.
Prosthetic heart valve
Also referred to as ‘artificial heart valves,’ these devices replace dysfunctional or diseased heart valves and are available in two forms, either mechanical or biological. Mechanical heart valves are made of man-made materials and typically can last a lifetime, while biological valves are made from tissue that is taken from animals or human cadavers.
Cardiac ablation catheter
These are long, thin tubes that are flexible in order to be threaded onto the heart or into it. Ablation catheters are designed to treat abnormally rapid heartbeats that are unable to be controlled with either medications or lifestyle changes. They work by modifying the small areas of the heart tissue that cause abnormal heart pace.
The U.S. Food and Drug Administration, or FDA, is the governmental agency that approves and regulates these medical device innovations, ensuring that manufacturers meet medical device compliance. The FDA has within it the Center for Devices and Radiological Health, or CDRH. This branch of the FDA was created to oversee the safety and effectiveness of all medical devices sold in the United States. In fact, this agency is responsible for maintaining every medical device on the American market, from low risk devices such as sutures, to more complicated mechanical innovations, including those designed to aid heart function. The FDA is also responsible for inspecting all companies that innovate new heart monitoring and assistive devices, ensuring that they follow strict regulations and uphold such medical device compliance.
