Cleveland Clinic physicians recently became among the first in the U.S. to implant a new miniature leadless cardiac pacemaker that stimulates the heart to a regular rhythm without the connecting leads or wires of a conventional device.
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If approved by the Food and Drug Administration, the device could improve patient comfort by:
- Replacing a surgical procedure with a percutaneous one (through the skin)
- Eliminating the visible lump and scar on a patient’s chest
- Removing the need for activity restrictions to prevent dislodging of conventional leads
A Cleveland Clinic patient with a slowed heartbeat is the third in the nation to receive the Nanostim device as part of an international, multicenter clinical trial testing its safety and efficacy for FDA approval. The procedure was performed by Daniel Cantillon, MD.
The Nanostim device resembles a small, metal tube and is a few centimeters long – less than 10 percent the size of a conventional pacemaker. Using a small flexible tube, doctors placed the battery-operated device into a vein in the leg and guided the pacemaker through the vein into the heart. The battery is expected to last about eight years.
The device and the less-invasive procedure used for implantation are aimed at lowering infection rates, speeding recovery and improving mobility afterward.
Traditional pacemaker surgery
Conventional pacemakers are placed under the skin of a patient’s chest, with insulated wires called leads that doctors guide into the heart and attach to the heart muscle. The conventional pacemaker can be seen under the skin and its placement leaves an incision scar. After receiving a pacemaker, a patient must limit certain activities to avoid dislodging the device.
Conventional pacemakers can be implanted in a special electrophysiology lab or during surgery, and although complications are uncommon, infections in the “pocket” under the skin where the device is implanted occur in 2 percent to 3 percent of cases. Areas around the leads can become infected as well.
Pending results of the clinical trial, the Nanostim device could be an important milestone because of its use of nanotechnology, which allows unprecedented miniaturization and the ability for doctors to implant the device directly in the heart, Dr. Cantillon says.
“Complications arising from traditional pacemaker surgery most often involve either the leads or patient’s chest incision. This device has neither,” Dr. Cantillon says. “Its miniaturization allows implantation directly into the heart using a catheter delivery system introduced from the femoral vein.”
Opportunity to advocate and innovate
Cardiac pacemakers treat a too-slow heart rate called bradycardia. The pacemaker closely monitors the heart’s electrical rhythms. If the heartbeat is too slow, the pacemaker provides electrical stimulation to regulate it.
More than 4 million patients around the world have a pacemaker, and 700,000 new patients receive one each year. A pacemaker keeps people’s heart rhythms at the proper speed so that they feel well or to avoid dizziness or fainting.
“This innovation could improve patient care if the North American clinical trial results are favorable,” says Dr. Cantillon, who holds a position on the study’s steering committee. “Through our participation in this trial, Cleveland Clinic has a significant opportunity to advocate for quality and patient safety in parallel with innovation.”