A cardiac pacemaker is a small device placed under the skin in the chest to control heartbeats, more regularly used in irregular heartbeats or arrhythmia. The rapidly rising elderly population across the globe is expected to increase the number of patients suffering from chronic cardiovascular diseases. The enormous and increasing burden of cardiovascular diseases among the global population and the alarming trends in cardiovascular risk profiles of young people are leading towards the increased adoption of cardiac pacemakers.
Cardiovascular medicine is rapidly evolving as advancements in technology and engineering provide clinicians innovative ways to care for an aging population. Cardiac pacing, in particular, has seen a series of game-changing technologies emerge in the past several years spurred by low-power electronics, high-density batteries, improved catheter delivery systems, and innovative software designs.
The continuous focus on innovation by leading players in the cardiac rhythm management devices industry, including cardiac pacemakers through increased R&D activities & related investments, has supported the emergence of enhanced features in pacemakers to offer better healthcare. Some notable advancements in the innovative cardiac pacemaker devices launched during the last three years include miniaturization, complete magnetic resonance imaging (MRI) compatibility, improved longevity with enhanced battery life, wireless remote monitoring features, and innovative leadless pacemakers.
Many leading players recently launched the MRI-conditional/compatible pacemakers by redesigning the components of pacemakers to minimize heating potential, dislodgement, current induction, and electromagnetic interference. For instance, Medtronic Public Limited Company (Ireland) received the U.S. FDA approval for three MR-conditional quadripolar cardiac resynchronization therapy-pacemakers, namely, PerceptaQuad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan, and Solara Quad CRT-P MRI SureScan.
In addition to this, pacemaker technology has also developed significantly over the years. Early batteries used nickel-cadmium or zinc mercury and had limited durability. Today’s lithium-iodine-polyvinyl pyridine batteries allow for smaller devices with much greater longevity. Lead designs have improved to provide greater stability at the interface with the myocardium and less susceptibility to flexion damage. To overcome the cardiac pacing system problem associated with lead infection, lead failure, and related lead replacement, there has been the introduction of leadless pacemakers.
Leadless pacemakers can be used in conjunction with a subcutaneous defibrillator for independent pacing and anti-tachycardia pacing. Apart from this, a crucial step in leadless PPM was achieved by reducing their energy requirements, which enabled the use of a miniaturized power source. Medtronic (Ireland) launched the world’s smallest leadless pacemaker Micra AV. Micra AV, with atrioventricular (AV) synchrony, received USFDA approval in January 2020. This pacemaker offers the advantages of leadless pacing, including a minimally invasive implant procedure and a cosmetically invisible device.
In addition to this, the batteries used in implantable cardiac pacemakers present unique challenges to their developers and manufacturers in terms of high levels of safety and reliability. In addition, the batteries must have longevity to avoid frequent replacements. Technological advances in leads/electrodes have reduced energy requirements by two orders of magnitude. Micro-electronics advances have sharply reduced the internal current drain, concurrently decreasing size and increasing functionality, reliability, and longevity.
Along with this, the pacemakers compatible with technology for remote monitoring with a smartphone or tablet were introduced. These had a higher rate of scheduled transmission success compared with other remote monitoring options. Medtronic plc (Ireland) BlueSync technology enables automatic, secure wireless communication via Bluetooth via the Medtronic CareLink Network. For instance, in October 2020, India Medtronic Private Limited, a subsidiary of Medtronic plc, launched the Azure pacemaker with BlueSync technology. This was designed to accurately detect and reduce the likelihood of atrial fibrillation and is the only pacemaker in India that can communicate directly with patients’ smartphones and tablets.
Further, one of the biggest trends in pacemaker technology in the last few years has been the introduction of U.S.FDA-cleared MRI-conditional models. These allow patients to undergo MR imaging exams without harming the device or changes to the device settings. Pacemakers without MRI-conditional use technology usually prevented patients from being able to get an MRI. New MR conditional devices are frequently released with improved designs to limit the interference of MRI. For instance, the Advisa MRI SureScan pacemaker (Medtronic) is the second-generation FDA-approved pacing system designed for safe use in the MRI environment when specific conditions are met. Advisa is available in single and dual chamber options. Also, the Azure pacemaker (Medtronic) detects changes in the heart.
Thus, the availability of these innovative products across various geographies, the ongoing innovations through rising investment & research are expected to increase the adoption of cardiac pacemakers and thereby accelerate the cardiac pacemaker devices market at a CAGR of ~3.1% to reach $4.34 billion by 2028, according to the Meticulous Research®.