Leadless Pacing

Happy couple walking hand in hand outdoors

This product is commercially available for use in select international markets. This therapy is not approved by the FDA for use in the United States. Caution: investigational device. Limited by Federal (or United States) law to investigational use.

Leadless Pacing: A First from St. Jude Medical

What if your pacemaker were invisible to everyone but you and your doctor?

It can be—with the Nanostim™ Leadless Pacemaker, the world’s first commercially available and self-contained leadless pacemaker.

This small cylindrical pacemaker is smaller than a AAA battery; it monitors your heart rhythm, stimulates your heart when needed and can provide information to your physician regarding your heart's performance. But unlike standard pacemakers, it resides entirely in the right ventricle of your heart. This pacemaker requires no leads, no chest incision, no scar and no permanent lump under the skin where the pacemaker sits.

Nanostim™ Leadless Pacemaker next to a one euro coin for size comparison
Doctor and patient discussion

How It Works

A normal, healthy heart automatically regulates its own heart rate. Unfortunately, some hearts beat too slowly or in an irregular pattern. If you are diagnosed with this problem, your doctor may recommend a pacemaker to correct it.

Nanostim leadless pacemaker is designed to achieve the same pacing results as a standard pacemaker, but the process for implanting the pacemaker is quite different from standard pacemakers. A standard pacemaker requires your doctor to create a surgical pocket to implant the pacemaker. Leads are then attached to the pacemaker and run to your heart, where they pace the heart.

Nanostim leadless pacemaker securely nestles inside your heart, sending small pulses of electricity when needed to prompt your heart to beat normally. The pacemaker requires no surgical pocket (no scar or lump), and it requires no leads. The pacemaker battery life is equivalent to that of similar standard single chamber pacemakers.


The Implant Procedure: What to Expect

To place this pacemaker, your doctor performs a minimally invasive procedure using X-ray images as a guide. A catheter that contains the pacemaker is passed through a small puncture in the groin and threaded into the heart.

For most people, the procedure is done under local anesthetic. You will be given some medicine to calm you and numbing medicine for your groin. The actual procedure will take about one hour, and in some cases less time. When it is over, you may have to wait in a recovery room until your doctor is certain you are ready for discharge.

The actual procedure will take about one hour, and in some cases less time.

Patient Education Handbook on Leadless Pacing

Questions You May Have

Q: Will I feel my Nanostim leadless pacemaker when it is in my heart, and what does a pulse from my leadless pacemaker feel like?

A: This pacemaker will probably not be noticeable to you. You should start to feel better, have more energy and be less fatigued. Other symptoms, such as dizziness, are likely to improve as well. Talk to your doctor if your symptoms do not improve in the first weeks and months after having your pacemaker implanted.

Most people cannot feel the pulse from the Nanostim leadless pacemaker at all. The electrical pulse is very small. If you do feel a pulse, your doctor or clinician may change the settings to make you more comfortable.

Get more answers

Get answers to other questions you may have and learn about your implant and follow-up care in our patient handbook.

Complications

Traditional pacemakers

Although the incidence of traditional pacemaker complications is relatively low (about 4 percent1,2,3), when complications occur, they typically happen in the pocket where the pacemaker is implanted or with the leads. In about 1 percent4,5 of patients, the pocket may become infected. In about 3 percent1,6 of patients, the leads may move out of place causing complications. Even if complications do not occur, all patients have a scar and lump where the pacemaker is implanted. In addition, research has shown that as many as 6 out of 10 patients experience reduced mobility in the shoulder region where the pacemaker is implanted.7

Nanostim leadless pacemaker

Similar to a standard pacemaker, rarely, the pacemaker may not act properly because it is being affected by outside sources of electromagnetic energy. It is also possible for the pacemaker to move from its original position in the heart that would impact the pacemaker's performance from regulating your heartbeat. This complication would require another surgery to remove the pacemaker and implant a new one. Finally, remember that these are man-made devices. It is important to monitor the device regularly with follow-up visits as often as your doctor recommends. 

Talk with your doctor to understand the potential risks* and benefits of this therapy.

St. Jude Medical Headquarters building in St. Paul, Minnesota

About St. Jude Medical

St. Jude Medical is a medical device company committed to advancing the treatment of some of the world’s most expensive epidemic diseases. That is one reason we are proud to be a market leader in creating next-generation medical therapies for expensive epidemic diseases such as atrial fibrillation and heart failure.

If you have questions or would like more information about the Nanostim™ leadless pacemaker, please contact our Technical Sales Team: +46 8 474 41 47

Learn more about St. Jude Medical.

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References

*Adverse Events: Potential complications associated with the use of the Nanostim™ leadless pacemaker system are the same as with the use of single chamber pacemakers with active fixation pacing leads including, but not limited to: cardiac tamponade; diaphragmatic/phrenic nerve stimulation; device embolism; air embolism; perforation; excessive bleeding; pulmonary edema; induced ventricular arrhythmias; infection; interruption of desired pulse generator function due to electrical interference, either electromyogenic or electromagnetic; loss of pacing and/or sensing due to dislodgment or mechanical malfunction of the device including battery malfunction; loss of capture or sensing due to embolization or fibrotic tissue response at the electrode; valve damage; pneumothorax/hemothorax; inability to interrogate or program device due to programmer or device malfunction; thrombosis; pericardial effusion; and increased capture threshold. As with any percutaneous catheterization procedure, potential complications include, but are not limited to: thromboembolism; air embolism; local and systemic infection; arterial puncture; bleeding or hematoma at puncture site; perforation (femoral vein or other structures); thrombus formation; embolization of the Nanostim leadless pacemaker; and femoral vein dissection. Talk with your doctor to learn more about the potential risks and benefits. Nanostim™ leadless pacemaker is designed, developed and manufactured by St. Jude Medical.

This product is commercially available for use in select international markets. This therapy is not approved by the FDA for use in the United States. Caution: investigational device. Limited by Federal (or United States) law to investigational use.

1. Pakarinen, S., Oikarinen, L., & Toivonen, L. (2009). Short-term implantation-related complications of cardiac rhythm management device therapy: A retrospective single-centre 1-year survey. Europace, 12(1), 103-108. http://dx.doi.org/10.1093/europace/eup361
2. Borek, P. P., & Wilkoff, B. L. (2008). Pacemaker and ICD leads: Strategies for long-term management. Journal of Interventional Cardiac Electrophysiology, 23(1), 59-72. http://dx.doi.org/10.1007/s10840-008-9249-7 
3. Gul, E. E., & Kayrak, M. (2011). Common pacemaker problems: Lead and pocket complications. In M. K. Das (Ed.), Modern pacemakers—present and future (299-318). Rijeka, Croatia: InTech Europe. Retrieved from http://cdn.intechopen.com/pdfs-wm/13786.pdf
4. Hercé, B., Nazeyrollas, P., Lesaffre, F., Sandras, R., Chabert, J-P., Martin, A., … Metz, D. (2012). Risk factors for infection of implantable cardiac devices: data from a registry of 2496 patients. Europace, 15, 66-70. http://dx.doi.org/10.1093/europace/eus284
5. Klug, D., Balde, M., Pavin, D., Hidden-Lucet, F., Clementy, J., Sadoul, N., … Kacet, S. (2007). Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators. Circulation, 116, 1349-1355. http://dx.doi.org/10.1161/CIRCULATIONAHA.106.678664
6. Kirkfeldt, R. E., Johanson, J. B., Nohr, E. A., Moller, M., Arnsbo, P., & Nielsen, J. C. (2011). Risk factors for lead complications in cardiac pacing. Heart Rhythm, 8(10), 1622-1628. http://dx.doi.org/10.1016/j/hrthm.2011.01.014
7. Daniels, J. D., Sun, S., Zafereo, J., Minhajuddin, A., Nguyen, C., Obel O., Wu, R., & Joglar, J. A. (2011). Preventing shoulder pain after cardiac rhythm management device implantation: A randomized controlled study. Pacing and Clinical Electrophysiology, 34(6), 672–678. http://dx.doi.org/10.1111/j.1540-8159.2010.03026.x