Medtronic (NYSE:MDT) said today the U.S. Centers for Medicare and Medicaid Services released a National Coverage Determination which will cover leadless cardiac pacemakers, including the company’s Micra TPS.
With the designation, Medicare patients will have access to Fridley, Minn.-based Medtronic’s Micra through Medicare’s policy of Coverage with Evidence Development, the company said.
The Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle to deliver single-chamber pacing, Medtronic said. The Micra device has an estimated 12-year battery life and is approved as safe for full-body MRI scans, the company said.
The CED policy requires additional evidence to be collected as a condition of the coverage. The decision will provide coverage when procedures with leadless devices are performed in FDA-approved studies and prospective longitudinal studies cleared by CMS, Medtronic said.
Medtronic said it will seek coverage of the existing FDA-approved Micra Post-Approval study as well as a new study tracking longitudinal data in the Medicare population. The company said coverage for the device will be effective upon approval of the studies by CMS.
“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. We are working closely with CMS to ensure patient access to the Micra TPS as quickly as possible under this decision,” Medtroinc cardiac rhythm and heart failure prez Dr. John Liddicoat said in a press release.
Micra won CE Mark approval in the European Union in April 2015 and landed FDA approval a year later.
Last August, Medtronic touted 12-month results for its Micra leadless pacemaker, released at the annual meeting of the European Society of Cardiology in Rome, showing a vastly lower safety profile than conventional implanted pacemakers.
The device beat the safety and efficacy endpoints in trial results released in November 2015, showing a 99.2% successful implantation rate and a freedom-from-major-complications rate of 96%, which the company said was 51% lower than the rate for conventional pacemakers.
