What is a Pacemakers Device?

A pacemaker is a small device that is placed near the chest or the abdominal area in order to control arrhythmia. During arrhythmia, the heart can beat too fast or too slow, thus creating an abnormal rhythm of the heart. The pacemakers can be used for sending electrical pulses in order to maintain the normal rhythm and rate of the heart. Pacemakers are also used in order to help the chambers of the heart to beat in sync so that the heart can pump blood efficiently to the rest of the body.

An individual might need a temporary/short-term pacemaker or a permanent/long-term pacemaker. A temporary/short-term pacemaker is inserted normally through a vein in the neck and tends to remain outside the body. The permanent pacemaker is placed in the chest or the abdomen

Pacemakers are used to treat patients suffering from arrythmias and are implanted in the chest or the abdominal region. They are small-sized electrical devices and are used in order to monitor the electrical impulse activity in the atrium and then assist in synchroinizing the electrical actvity with the intrinsic impulse activity of the heart.

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Mechanism of Pacemakers:

Pacemakers work by using low-energy electrical pulses for controlling the rate and the rhythm of an individual’s heartbeat. The traditional pacemakers send electrical pulses via wires, also known as the leads. The wireless forms of pacemakers are a newer type of pacemakers that are able to send signals without leads.

Traditional Pacemakers

The traditional form of pacemakers, also known as the transvenous pacemakers are composed of three main parts: The device is composed of pulse generators which creates electric pulses. Wires/leads, which are implanted inside the veins and are used for carrying pulse to the heart. Electrodes that sense the normal heartbeat. In case the heart beats are slower than normal, the electrical impulses that are sent by the pacemaker revert the normal functioning of the heart.

Wireless pacemakers

Wireless pacemakers are smaller in size than the traditional form of pacemakers. The pulse generator and the electrodes are all in one device that can be implanted inside the chambers of the heart via a small tube inserted in one of the veins. No surgery is required for the process. After the pacemaker is placed, it can then be used for sending pulses to the right ventricle. Wireless forms of pacemakers are recommended if the patient has a slow heartbeat, or in case of an electrical block, that can be observed when the flow of electricity is delayed to the heart region between the upper and lower chambers of the heart of an individual.

Indications for which Pacemakers are recommended

Pacemakers are used for treating certain types of arrhythmias, as well as heart failure, a conditions that can be observed when the heart is not able to pump adequate amount of blood to the body. Other problems where a pacemaker is recommended involves problems associated with electrical signaling in the heart, certain congenital heart defects, heart attacks, heart transplants among others.

Pacemakers are devices that are implanted to maintain the irregular heartbeat activity in the body, also known as arrhythmias. These devices belong to Class III. The device should be classified using the search engine through the FDA classification database. The manufacturer must implement a Quality Management System (QMS) that meets FDA. Quality System Regulation (QSR). Clinical studies are required for the innovative Class II and all Class III devices. The sponsor shall get a “Pre-Submission (Pre-Sub)” feedback from the FDA. An Investigational Device Exemption (IDE) must be applied if clinical studies are required and sponsor should develop clinical trial protocol and conduct study. After that the manufacturer must prepare and submit a PMA Premarket Notification application and pay required fee. FDA issues PMA approval letter and is posted online.

Cardiac pacemakers are covered as prosthetic devices under the Medicare program, subject to the following conditions and limitations. While cardiac pacemakers have been covered under Medicare for many years, there were no specific guidelines for their use other than the general Medicare requirement that covered services be reasonable and necessary for the treatment of the condition. Services rendered for cardiac pacing on or after the effective dates of this instruction are subject to these guidelines, which are based on certain assumptions regarding the clinical goals of cardiac pacing.

While some uses of pacemakers are relatively certain or unambiguous, many other uses require considerable expertise and judgment. Consequently, the medical necessity for permanent cardiac pacing must be viewed in the context of overall patient management. The appropriateness of such pacing may be conditional on other diagnostic or therapeutic modalities having been undertaken. Although significant complications and adverse side effects of pacemaker use are relatively rare, they cannot be ignored when considering the use of pacemakers for dubious medical conditions, or marginal clinical benefit.