No matter what your friends, girlfriend or co-workers tell you, when it comes to pacemakers, size matters. Since the advent of cardiac rhythm management (CRM), we've come to accept the fact that pacemaker implantation means invasive procedures, skin protrusion and a high risk of infection or lead malfunction CRM devices, which include pacemakers, defibrillators and cardiac resynchronization therapy systems, all currently require wires called leads to connect the pulse generator into the heart.
However, the leadless pacemaker is challenging these conventions; this type of device is implanted transcutaneously and is placed directly in the heart, eliminating the necessity for leads. St. Jude Medical is trailblazing the way to leadless pacing with its Nanostim pacemaker followed closely by Medtronic's Micra. The sizes of these devices are comparable to a small battery or a large vitamin, respectively. Currently, only the Nanostim has received a CE marking and clinical trials for both devices have started at the end of 2013.
This technology is innovative and opens up the possibility of eliminating leads completely from CRM devices. Thus it's no surprise that physicians are excited. Furthermore, the innovation aligns well with the medtech trend toward transcutaneous approaches at the expense of surgical procedures. This just goes to show that the old and mature CRM device market can still learn new tricks.