The U.S. Food and Drug Administration (FDA) said yes to the world’s first leadless pacemaker on Wednesday. It was reported in a press release that ‘more than four million people worldwide have an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive the devices each year.’
The Future Is Here: FDA Clears Leadless Pacemakers
Keeping these statistics in mind, two never seen before devices have been developed so far, one being manufactured by Medtronic’s (MDT) largest division, Cardiac Rhythm Disease Management (CRDM), called the Mirca Transcatheter Pacing Systems (TPS), and the other by St Jude, known as the Nanotism Leadless Pacemaker.
These silver metal tubes are both just an inch long and can easily fit in the palm of your hand. Their main function is to monitor the heart and regulate cardiac arrhythmia and treat bradycardia which is an abnormally slow heart action. The new pacemakers have a longer battery life of more than 12 years and are far more comfortable for the patient to use without the complicated use of wired leads and surgical pockets which the previously designed conventional pacemakers all had. The Mirca TPS (Medtronic) and Nanotism (St Jude) both serve features that are similar to those of the conventional pacemakers and are implanted in a laboratory setting by being directly planted inside the right ventricle of the heart with the help of a catheter. It is designed to automatically track patient’s activity levels and respond to it by adjusting the required therapy needed to complete the process.
Dr William Katsiyiannis, a cardiologist at Abbot Northwestern Hospital, says ‘The smaller devices address the weak links of pacing technology.’ He further goes on to say that ‘leads that go into the heart are under the stress of a beating heart over a hundred thousand times a day. They’re bent and twisted by the heartbeat. That lead over time breaks down and the insulation or the wires themselves become subject to failure.’
FDA formed its consent to give these devices a nod after various clinical trials were carried out, both randomized and non-randomized, to test the efficacy, safety and long term performance. In the Micra TPS Global Clinical Trial, patients who had used the Mirca device showed a very high success rate. The device has been planted in up to 96 patients with no complications. Leadless II researchers in their pivotal trial state that ‘the Nanotism was successfully implanted in 96 percent of 526 subjects’ and has proven to be useful and safe.
Medtronic is the world’s largest company specializing in medical technology, services and solutions. It offers facilities to approximately 168 countries and has as far as 85,000 employees, all helping patients, physicians and hospitals. St Jude medical has also made numerous contributions in the medical world by providing treatment at a reduced cost for all.
Dr Udo, who presented his research at the ESC congress in 2013, says, “Previous studies describing the survival of pacemaker patients used data that is more than 20 years old and cannot be used anymore for patient counseling and benchmarking. There have been considerable changes in pacemaker technology and in the profile of pacemaker patients and a new reference point of prognosis in modern day cardiac pacing was needed.’
Both devices, however, only serve the function of a single chamber pacing, which restricts their use. A dual chambered leadless pacemaker may have the potential to change the future. Work is already underway to improve the quality and function of these devices.