St. Jude Medical
The Nanostim has already been approved for use in Europe.
Unfortunately, those wires can break or get dislodged in the body. If the insulation sheathing them from the body cracks, it leads to a nasty infection.
Enter the pacemaker of the future: A wireless, coin-sized gadget that doesn't require surgery and can be implanted directly inside the heart in about 28 minutes.
While the new pacemaker still needs to be tested in large numbers of patients, if you're one of the few people across the country who's currently trying it out, the device is less futuristic than realistic.
Marlene Artale was the first patient in Ohio to have the gadget placed inside her heart. On Feb. 14, doctors at the Cleveland Clinic used a catheter inserted in her leg vein to steer the device deep into her right ventricle.
The gadget, called Nanostim and owned by St. Jude Medical, is powered by a lithium battery that's designed to last 8-10 years at minimum (about the same as a traditional pacemaker) and 19 at most. If it needs replacing, doctors can remove it the same way they inserted it (via a catheter) and put in a new one - though there are still questions about how challenging that process will be after the device has been implanted for many years.
Before receiving the new device, Artale experienced debilitating fainting spells twice a week. She had a common irregularity called atrial fibrillation that was being worsened by an already irregular heartbeat that resulted from tachy-brady syndrome. As a result, Artale's heartbeat would repeatedly climb to a rapid crescendo and then gradually slow down again. Sometimes, her heart would stop beating completely, her doctor told the Cleveland Clinic. These periods worried her the most.
The new pacemaker helps Artale by monitoring her heart rate using a tiny electrode. If Artale's heart is beating too slowly, it uses its generator to nudge it into action via a gentle electric shock.
St. Jude Medical
The new pacemaker is placed in the heart's lower right chamber.
While traditional pacemakers have been used for decades, they can have complication rates as high as 15%. In the latest Nanostim study, which involved a very small cohort of 33 patients, just 6% (2 patients) experienced complications. Still, as the researchers noted, "only a randomized trial with a control group could prove the hypothesis that there would be more complications with traditional pacemakers."
St. Jude is now going full speed ahead with a study to try to prove just that.
Artale is part of a nationwide trial of the device that will eventually enroll as many as 700 patients like her. A larger post-approval trial in Europe is also in progress, though it was temporarily halted after two patient deaths. (According to reports, researchers adjusted the criteria for who could be included in the trial, and it was allowed to proceed.)
If all goes well in the US trial, the FDA could approve the device as early as next year. Medtronic and Boston Scientific are working on similar devices, but the Nanostim is the furthest along.
See how the device is implanted and works inside the heart, in this video from St. Jude: