Medtronic wins CMS coverage for Micra leadless pacer

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...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Centers for Medicare and Medicaid Services (CMS) Medtronic Source Type: news