Medtronic has secured Medicare coverage for its leadless pacemaker, Micra Transcatheter Pacing System (TPS). The Centers for Medicare & Medicaid Services (CMS) agreed to cover Micra TPS through its Coverage with Evidence Development, a policy that adds products to Medicare provided the manufacturer generates additional data.
The terms of the agreement mean Medicare, a U.S. federal health insurance program for people aged 65 or older, will only start covering Micra TPS once the CMS has approved two studies. Medtronic is seeking coverage of an existing postapproval trial and a planned study tracking longitudinal data on patients in the Medicare population. The postapproval trial is looking at the acute complication rate and long-term complication-free survival in patients who receive Micra TPS in the real world.
By adding a study focused on the Medicare population to its postapproval activities, Medtronic has secured Medicare coverage of patients in the trials nine months after FDA cleared the device for use in people who need a single-chamber pacemaker.
"Medtronic is pleased with the CMS decision to cover leadless pacemakers, which will allow broad patient access to this novel, minimally invasive pacemaker technology through an innovative approach to evidence and data collection to address research questions identified by CMS," Medtronic SVP John Liddicoat said in a statement.
Micra TPS stands apart from traditional pacemakers because of its size. At one inch long, the device is considerably smaller—Medtronic claims 93% smaller—than traditional pacemakers. And, unlike the competition, it is leadless. The device is hooked on to the heart using small prongs.
Medtronic thinks the design cuts the risk of complication. The complication rate in a 719-person trial came in below 7%. Subsequent long-term follow-up data linked Micra TPS to a 47% drop in risk of hospitalization and an 82% fall in the risk of the device needing removal, repositioning or replacement.