Minimally Invasive Pacemaker Implant from Medtronic Has Been Approved By the FDA

The compact, portable, and minimally invasive pacemaker implant from Medtronic has been approved by the FDA. It is less than one-tenth of the size of conventional pacemakers and does not require separate electrode wiring to run between the heart and the implant; the company claims that their system would open up pacemaker treatment options for those who otherwise would not have undergone the operation. The Micra AV system is recognized as one of the smallest pacemakers in the world which ismounted entirely within the right heart ventricle. This system is attached to the muscle wall using small tines, which can be inserted in a minimally invasive procedure via a catheter compared to larger conventional devices usually installed under the skin near the collarbone, which need to be connected with electrical leads to the organ.

 “The introduction of Micra AV reinvents our own innovation, bringing the many benefits of leadless pacemakers to more patients,” said Rob Kowal, chief medical officer and vice president of medical affairs for Medtronic’s cardiac rhythm and heart failure division.

Approval of the FDA was obtained after a successful clinical study testing the movement-based sensing algorithms of the system and the ability to detect atrial contractions as well as coordinate pacing in which results showed that 95 percent of the participants displayed 70 percent or greater atrioventricular synchrony with the treatment.