FDA approves injectable pacemaker that does not require surgery

Cardiovascular patients who need a pacemaker need not, in the future, undergo surgery to have the life-saving device implanted. The US Food and Drug Administration (FDA) just approved Medtronic’s injectable pacemaker.

Besides being just one inch long, or a tenth of traditional pacemakers which makes it the smallest in the world, the Micra Transcatheter Pacing System does not need wired leads, a cause of complications. The new device is for atrial fibrillation patients, people suffering from irregular or rapid heart rate, reports Gizmodo.

Medtronic, maker of medical devices such as blood pressure monitors, got the FDA green light after a clinical trial with 725 patients, 99.2 percent of whom experienced adequate heart pacing six months after the device was implanted on them. It reduced complications by 51 percent in comparison to traditional pacemakers.

With the miniature pacemaker, patient experience has been redefined as the device’s ultra low-power circuit design delivers an estimated average 12-year battery longevity, according to Medtronic. There is no chest scar, bump or any other visible or physical reminder of its implantation.

The minimally invasive procedure involves the insertion of a thin 41-inch tube into a vein in the patient’s groin which travels through the vein until the pacemaker reaches the right ventricle of the heart. In contrast, conventional pacemakers are surgically implanted and need wired leads that run from the pacemaker to an implant placed below the collarbone.

Its leads run through a vein directly into the right ventricle of the heart and delivers electrical impulses to treat stalled or irregular heartbeats. But the wires, besides being clunky, sometimes malfunction and could cause more problems when infection develop in the surrounding tissues which require another operation to replace the pacemaker.

However, the Micra could only pace the heart’s lower chamber. It can’t be used by patients who require pacing in the upper and lower chambers. The FDA also says it cannot be used by patients with implanted devices, severely obese people and patients intolerant to heparin, a blood thinner, or to the materials in Micra.