St Jude Medical unveils world\'s-first leadless pacemaker


Nanostim marks a breakthrough in cardiac care

St Jude Medical has announced the launch of the world’s-first leadless pacemaker.

Nanostim has just received CE Mark approval and has the potential to revolutionise cardiac care in the UK.

More than four million people worldwide have devices such as a pacemaker implanted to regulate their heartbeat, and an additional 700,000 patients receive them each year.

Considered one of the most-significant advances in pacemaker technology in decades, the Nanostim leadless pacemaker is smaller than an AAA battery and less than 10% of the size of available conventional pacemakers. It is implanted via minimally-invasive surgery and eliminates leads and surgical pockets known to cause device-related infections, lead failure and cosmetic issues.

It communicates to programmers through conductive communications – a relatively new avenue for devices that measures the electrical activity in the heart by placing electrodes on the body. It does this without depleting its battery, an issue that has been the limiting factor preventing the advance of current leadless technologies under development.

Initial results from the LEADLESS study, a study evaluating patients with the Nanostim leadless pacemaker, were presented earlier this year and demonstrated overall device performance comparable to conventional pacemakers.

As part of the announcement, St Jude has acquired Nanostim, the privately-held company that designed the device.

Facts about leadless pacemakers

What is a leadless pacemaker?

A leadless pacemaker is a small implantable device that sends electrical pulses to the heart whenever it senses the heartbeat is too slow. Leadless pacing devices are placed directly in the heart without the need for a surgical pocket and insulated wires, known as leads.

How does a conventional pacemaker work?

Conventional pacemakers work as part of a pacing system that consists of a pulse generator and pacing leads. The pulse generator is a device implanted just below the skin near the collarbone. It contains the battery and the electronic circuitry of the pacemaker, which directs the battery to send electrical pulses to the heart. The leads are thin wires that are inserted through a vein, which connect the generator to the heart. The leads also pick up the patient’s own heart rhythm and transmit this information to the generator, which adapts its responses to the patient’s needs. Conventional pacemakers require the doctor to make a surgical incision in the chest where a pacemaker permanently sits in a pocket under the skin. The doctor then implants leads from the pacemaker through the veins into the heart. These leads deliver electrical pulses that prompt the heart to beat at a normal rate.

How does a leadless pacemaker work?

Unlike conventional pacemakers, a leadless pacemaker is placed directly in the heart without the need for a surgical pocket and pacing leads. The device is much smaller than a conventional pacemaker and is comprised of a pulse generator that includes a battery and a steroid-eluting electrode that sends pulses to the heart when it recognises a problem with the heart’s rhythm. Leadless pacemaker technology is made up of computer chips and a small, but long-lived battery in a sealed case that resembles a AAA battery. The device is implanted through a vein that passes fairly close to the outer surface of the upper thighs. Because the implant procedure does not require surgery like a traditional procedure, it is considered a less-invasive approach for patients who need pacemaker technology.

What is Nanostim?

Nanostim is the world’s-first and only commercially-available leadless pacemaker. It offers patients a minimally-invasive option for pacemaker delivery. Implanted via the femoral vein with a steerable catheter, the device offers a less-invasive approach that eliminates the surgical pocket and lead, potentially reducing overall complications such as device-related infection of the pocket and lead failure. The small size of the device, coupled with the lack of a surgical pocket, improves patient comfort. In addition, the removal of patient activity restrictions that may prevent the dislodgement of a conventional lead may potentially improve the quality of life for patients with this technology.

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