Medtronic announced new, long-term data from a clinical evaluation of its inch-long leadless pacemaker, which, in April, was the first device of its kind to win FDA approval.
One-tenth the size of a traditional pacemaker, the Micra Transcatheter Pacing System does not need wired leads to connect itself to the heart. The only leadless pacemaker approved in the U.S. and Europe, the Micra is inserted minimally invasively via catheter rather than requiring a surgical procedure. It attaches to the heart using small tines and paces the heart with electrical impulses delivered through an electrode, the company said.
The new data showed that the risk for complications with the Micra remained low over the long term: 96% of patients had no major complications in the 12 months following implantation, according to a statement. The device cut the risk of hospitalization by 47% thanks to a 48% reduction in risk of major complications, compared with traditional pacemakers. It also dropped the risk of revision surgery--to remove, reposition or replace the device--by 82%.
"The Micra TPS has also shown a significant reduction in healthcare utilization compared to conventional pacemakers, which is promising for clinicians looking to adopt cost-effective therapies to improve patient outcomes,” said Dr. John Liddicoat, a Medtronic senior vice president and president of the devicemaker’s Cardiac Rhythm and Heart Failure unit, in the statement.
Micra is FDA-approved for patients with heart arrhythmia conditions, such as atrial fibrillation and bradycardia-tachycardia syndrome, but not for patients who have other implanted devices that may interfere with it. It is not indicated for severely obese patients, those with an intolerance for the device materials and those taking the blood thinner heparin, or those or whose veins are too small to accommodate the implant or the sheath used to deliver it.
- here's the statement