Pacemakers were developed in the 1950s and were mainly aimed at treating life-threatening heart blockages that occur after cardiac surgery. Though these devices were able to increase the life span, they were plagued by many disadvantages, including short life span of the battery, lead failure, and infections caused due to surgery.  Many of these same issues are present today with most left ventricular assisted pacemaker devices. With advancements in technology, the size of pacemakers has reduced significantly, which allowed for the first pacemaker to be implanted in Sweden in 1958. Trans-venous lead was developed and first used in pacemaker devices by Parsonnet etal. These early pacemakers had limited functionality and could only perform asynchronous pacing. Rapid advances have been made with pacemaker technology, including rate and output, to allow noninvasive communication with devices and improved battery technology in order to extend the life span of the pulse generator by one year. 

Trans-venous cardiac pacemakers have improved life and reduced mortality for patients. However, these pacemakers are still associated with many potential device-related complications. It is estimated that around 10% of patients experience complications related to trans-venous implantation of pacemakers. Conventional pacemakers are reliable, but they still face many limitations that arise from the subcutaneous pocket where pacemakers are placed. These may give rise to skin erosion. The use of trans-venous lead can lead to pneumothorax or deep vein thrombosis. Leadless pacemakers are of two types: single chambered and double chambered. Until now around five million conventional pacemakers have been implanted worldwide, and out of these, nearly 20% cases have failed annually because of lead wiring.

In order to eradicate the difficulty arising due to lead wiring, researchers have developed leadless pacemakers. Leadless pacemakers are designed to achieve the same pacing result as conventional pacemakers. Leadless pacemakers are self-contained devices that can be easily implanted within the right ventricle of the heart without surgery through the use of a catheter induced via the veins in the leg, thus leaving no scar marks.

The major drivers of the global leadless pacemaker market are an increase in the geriatric population, rise in the incidence of cardiovascular disorders, technological advancements, increase in health care expenditure, and rise in in favorable government reforms for promoting health care facilities.  Moreover, other factors such as avoiding the use of harmful lead, no infections and scar marks, MRI compatibility, and no postoperative mobility restriction are anticipated to boost the global leadless pacemaker market. However, factors such as lack of adequate personnel to perform procedures, reimbursement issues, and high cost of implantation are expected to drive the global leadless pacemaker market.  The cost of leadless pacemakers is approximately four times that of conventional pacemakers.

The global leadless pacemaker market can be segmented based on technology, end-user, and geography. In terms of technology, the global leadless pacemaker market can be divided into single chambered, double chambered, subcutaneous ICD leadless pacing, and other. Based on end-user, the leadless pacemaker market can be classified into hospitals, ambulatory surgical centers, academic & research institutes, and others.

Based on geography, the global leadless pacemaker market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America is expected to lead the global leadless pacemaker market, due to high prevalence of cardiac-related diseases and presence of major players in the global leadless pacemaker market. The market in North America was closely followed by that in the European region.

The leadless pacemaker market in Asia Pacific is anticipated to provide a lucrative market opportunity during the forecast period, owing to increasing patient population, technological advancements, and rising demand for efficient pacing systems. The market in Latin America and Middle East & Africa is expected to expand due to an increase in focus of manufacturers in the region for business expansion.

Major players operating in global leadless pacemaker market are Abbott, Medtronic’s, Boston Scientific Corporation, Biotronik, and others. Increase in product approvals and technological advancement is expected to drive the market during the forecast period. For instance, Micra Trans-catheter Pacing System (TPS) pacemaker by Medtronic’s received the U.S. FDA approval in April 2016.

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