The Micra won reimbursement through Medicare’s policy of Coverage with Evidence Development, the Fridley, Minn.-based company said.
At 1/10th the size of a conventional pacemaker, or roughly the size of a large vitamin, Micra is designed to be implanted via catheter in the right ventricle to deliver single-chamber pacing. The device has an estimated 12-year battery life and is approved for full-body MRI scans. The FDA approved Micra in April 2016.
Medtronic said that in Jan., CMS issued a National Coverage Determination that covered leadless pacemakers under its CED policy when used in accordance with FDA-approved labeling in FDA approved studies. The company has 2 Micra studies approved by CMS – the Micra post-approval study and a longitudinal coverage study which looks to address questions identified by CMS in its NCD.
The PAS study is slated to enroll a subset of Micra patients through a traditional clinical research design, while the CED study will examine all Medicare Micra beneficiaries.
“Since the Medicare coverage decision was announced earlier this year, we have been working closely with CMS to secure study approvals which will provide additional evidence supporting the Micra TPS. We are pleased that all Medicare beneficiaries indicated for Micra according to the FDA label are now covered by the NCD and, as a result, have access to this innovative pacing technology,” Medtronic cardiac rhythm & heart failure division prez Dr. John Liddicoat said in a press release.
In February, Medtronic said that Japanese regulators approved its Micra leadless pacemaker. Medtronic said the approval from Japan’s Pharmaceuticals & Medical Device Agency was based on its single-arm, 744-patient Micra TPS study at 56 centers in 19 countries including Japan.