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Leadless Pacemakers Assuage Shortcomings of Conventional Predecessor Devices, Seek Approval from US FDA

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Published on : Dec 28, 2015

Technology is an intrinsic part of medical advancement is well recognized. Be it for cardiac care, renal diseases or cancer care, right from the diagnostics to treatment and rehabilitation, technologically advanced devices and clinically tested procedures are the standard. In this context, medical devices that are used to control arrhythmic heartbeats are transforming from conventional wired ones to leadless type. 

Pacemakers, as these devices are called, have been in use for a very long time, and are essential for individuals with slow heartbeats. However, these devices are associated with issues that are vitally related with – incision needed in the upper part of the chest to implant the device and the wired connection from the generator to the heart’s muscle that delivers energy.

Particularly, the wire is associated with several problems such as fracturing over a period of time and getting absorbed into the healing tissue that can lead to building of scar tissue. Removing the wire for reasons of fracture or infection is complicated as well. For these reasons, leadless pacemakers have been sought for quite some time, however, technological advances in the near recent have allowed the manufacture of these devices. 

The design of leadless pacemaker is the distinguisher that has brought a striking change in the utilization of these devices. This includes generator, pacing element, and electronics that are of minuscule sizes, which allows the surgical procedure to be avoided altogether. Instead, with the help of a transvascular procedure, the device is advanced through a vein in the leg to the heart’s right ventricle. 

For the purpose of installing or removing if needed, the device has a hook at its back end that the catheter can latch on as per the need. This is essentially how a leadless pacemaker works. 

Nanostim developed by St Jude Medical is the pioneer leadless pacemaker. After the necessary feasibility testing, the device approved for use in Europe found its way to being used on the first patient in the U.S. in December 2014. The first leadless pacemaker was implanted at the Mount Sinai Hospital, New York that led to a pivotal trial for the device to receive FDA approval.