News | Pacemakers | March 10, 2017

Leadless Pacemaker Gains Medicare Reimbursement

CMS approves required studies for the Micra Transcatheter Pacing System (TPS), the world's smallest pacemaker

Micra leadless pacemaker, CMS, medicare reimbursement

March, 10, 2017 - Medtronic announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has approved coverage for the Micra Transcatheter Pacing System (TPS). This decision, effective immediately, follows the approval of two studies required to enable reimbursement through Medicare's policy of Coverage with Evidence Development (CED).
 
In January 2017, CMS issued a final National Coverage Determination (NCD) that covered leadless pacemakers under CED when used in accordance with U.S. Food and Drug Administration (FDA)-approved labeling in FDA-approved studies that have been approved by CMS, or under prospective, longitudinal studies approved by CMS. The two Micra studies approved by CMS are the Micra Post-Approval Study (PAS), which was required by the FDA as a condition of approval of the device in April 2016, and a new Micra CED Study, the "Longitudinal Coverage with Evidence Development Study on Micra Leadless Pacemakers," which was developed by Medtronic to address research questions identified by CMS in the NCD.
 
The Micra PAS Study will enroll a subset of Medicare Micra patients through a traditional clinical research design, while the Micra CED Study will encompass all Medicare beneficiaries who receive Micra under an innovative new approach to CED, linking information from Medtronic's device registration system to Medicare health insurance claims and enrollment data.
 
"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," said John Liddicoat, M.D., senior vice president, Medtronic, and president of the cardiac rhythm and heart failure division. "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."
 
Approved by the FDA in April 2016 for patients who need a single-chamber pacemaker, the Micra TPS is the first and only leadless pacemaker approved for use in the United States. The miniaturized device was recently named at the top of U.S. News & World Report's list of "2016's Biggest Achievements in Medicine."
 
Comparable in size to a large vitamin, the Micra TPS is less than one-tenth the size of traditional pacemakers, yet delivers the most advanced pacing technology to patients via a minimally invasive approach. During the implant procedure, it is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.
 
Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical pocket under the skin, so potential sources of complications related to leads or pockets are eliminated.
 
The Micra design incorporates a retrieval feature which can be enabled, if possible; however, the device is designed to be left in the body. For patients who need more than one device, the miniaturized Micra TPS can be permanently turned off, allowing it to remain in the body so a new device can be implanted without risk of electrical interaction.

The Micra TPS is the first and only leadless pacing system to be approved for both 1.5 and 3 Tesla full-body magnetic resonance imaging (MRI) scans. It is designed to allow patients to be followed by their physicians and send data remotely via the Medtronic CareLink Network. Remote monitoring of Micra devices is expected to be available later this year.
 
Primary results from the Medtronic Micra TPS Global Clinical Trial, published November 2015 in the New England Journal of Medicine, showed the Micra TPS was successfully implanted in 99.2 percent of patients by 94 physicians around the world and that the system met its safety and effectiveness endpoints at 6 months follow-up with wide margins. Long-term results from the Micra Trial, published November 2016 in Heart Rhythm, reinforced these data, showing the risk of major complications at 12 months for Micra patients was low at 4 percent, 48 percent lower than for patients with traditional pacemakers (hazard ratio: 0.52, 95% CI: 0.35-0.77, P=0.001).

Read the article "One-Year Results for Micra TPS Pacemaker Trial Presented at ESC 2016."

For more information: www.medtronic.com

Related Content

An interventional radiologist consults with a patient in an out patient cath lab at a Modern Vascular clinic. The company is building several out patient clinics to capture a share of the interventional market for peripheral artery disease (PAD) catheter-based therapies. 

An interventional radiologist consults with a patient in an out patient cath lab at a Modern Vascular clinic. The company is building several out patient clinics to capture a share of the interventional market for peripheral artery disease (PAD) catheter-based therapies. 

News | Cardiovascular Business | February 03, 2021
February 3, 2021 — Modern Vascular is a medical group that has 13 outpatient cath lab clinics to treat...
COVID-19 cardiology related content continues to be among the top performers on the DAIC website in November 2020. TAVR also topped headlines with Boston Scientific taking its Lotus valve off the market and a review of TAVR registry data showing it is now the dominant method of aortic valve replacement in the United States. #DAIC

COVID-19 cardiology related content continues to be among the top performers on the DAIC website in November 2020. TAVR also topped headlines with Boston Scientific taking its Lotus valve off the market and a review of TAVR registry data showing it is now the dominant method of aortic valve replacement in the United States.

Feature | Cardiovascular Business | December 01, 2020 | Dave Fornell, Editor
December 1, 2020 — Here is the list of the most popular content on the Diagnostic and Interventional Cardiology (DAIC
Survey data showing opinions of physicians and hospital administrators on barriers to implementing new technology and how new technologies have improved cardiovascular care.

Survey data showing opinions of physicians and hospital administrators on barriers to implementing new technology and how new technologies have improved cardiovascular care.

News | Cardiovascular Business | September 14, 2020
September 14, 2020 — New global research released by Abbott takes a deep dive into the barriers of cardiovascular pat
Philips angiography system in a cath lab at Henry Ford Hospital.
Feature | Cardiovascular Business | July 13, 2020 | Deb Thompson and Christian Comeau
For a cardiovascular service line leader, addressing challenges in an evolving healthcare climate is a constant.
Leeds Hospital recently installed Philips Azurion angiography interventional labs to enhance procedural guidance capabilities.

Leeds Hospital recently installed Philips Azurion angiography interventional labs to enhance procedural guidance capabilities.

News | Cardiovascular Business | July 08, 2020
July 8, 2020 – Philips Healthcare and Leeds Teaching Hospitals NHS Trust announced a seven-year managed service agree
Medicare will pay for telehealth virtual doctor visits during the duration of the coronavirus COVID-19 outbreak.
News | Cardiovascular Business | March 17, 2020
March 17, 2020 — The Trump Administration today announced expanded Medicare telehealth coverage that will enable bene
Recognized as the “Pulitzer Prize of the business press,” the Jesse H. Neal Award finalists are selected for exhibiting journalistic enterprise, service to the industry and editorial craftsmanship
News | Cardiovascular Business | February 19, 2020
February 19, 2020 — Connectiv, a division of The Software and Information Industry Association (SIIA), has announced