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CMS decides to cover first leadless pacemaker
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Medtronic announced that CMS will now cover its leadless pacemaker, the first of its kind on the U.S. market.
The CMS issued a national coverage decision providing access to the leadless pacemaker (Micra TPS) for Medicare patients consistent with FDA-approved labeling through Medicare’s Coverage with Evidence Development policy, according to a press release from Medtronic.
Under the policy, coverage for the technology will be provided for patients receiving it in FDA-approved studies or in prospective longitudinal studies approved by CMS, according to the release.
"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," John Liddicoat, MD, Medtronic’s senior vice president and president of its Cardiac Rhythm and Heart Failure division, said in the release. "We are working closely with CMS to ensure patient access to the Micra TPS as quickly as possible under this decision."
According to the press release, the leadless pacemaker, which is less than one-tenth the size of traditional pacemakers, is compatible with both 1.5 and 3 Tesla MRI scans, allows patients to send data remotely to physicians and is expected to provide remote monitoring later in the year.
In preliminary results of the Medtronic Micra TPS Global Clinical Trial, published in The New England Journal of Medicine, the Micra TPS was associated with a successful implantation rate of 99.2% and met its primary safety and efficacy endpoints, and results were consistent at 1 year, according to the release.
Disclosure: Liddicoat is an employee of Medtronic.