World's Smallest Pacemaker Can Be Fitted Without SurgeryPublished: Tuesday, April 12, 2016 By: Anthony Cuthbertson Source: Newsweek
A tiny pacemaker that requires no surgery to be implanted, nor leads to operate, has become the first such device to receive approval from the U.S. Food and Drug Administration.
The Micra Transcatheter Pacing System (TPS) from Medtronic is around the same size as a vitamin pill, just one tenth of the size of traditional pacemakers. The clinical trial—conducted at 56 centers across 19 countries—demonstrated 51 percent fewer complications after six months, compared to traditional devices.
“For many years we’ve been hopeful that a transcatheter pacing solution—with a safety and effectiveness profile on par with conventional devices—would become available, and today Micra has achieved this milestone,” Dwight Reynolds, chief of the Cardiovascular Section at the University of Oklahoma Health Science Center and principal investigator in the Micra TPS clinical trial, said in a statement.