The Centers for Medicare & Medicaid Services (CMS) has granted approval to the Micra Transcatheter pacemaker (Micra TPS) that is manufactured by Medtronic plc. Ordinary Shares (NYSE:MDT). This was done after two studies were conducted and which were fundamental in order to allow for reimbursement though the CMS program.
One of the two studies was necessary in order for the Food and Drug Administration to approve the device while the other one was required in order to address questions that had been raised by Centers for Medicare & Medicaid Services.
“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,” Senior Medtronic VP, John Liddicoat, said.
FDA approval
The Micra TPS got the approval of the Food and Drug Administration in 2016 and is aimed at patients who require a pacemaker that comes with a single-chamber. In the United States, it is the only pacemaker that is leadless that has received approval for use. A recent U.S. News & World Report named the device as one of the biggest achievements of 2016 in medicine.
Despite being around 10% the size of regular pacemakers, Micra TPS offers pacing technology that is highly advanced and in a way that is minimally invasive. During the procedure for implanting it, the process of attaching the device to the heart is done using small tines. This assists in delivering electrical impulses that are involved in the pacing of the heart using an electrode that is located at the device’s end.
Surgical pockets
Another difference the Micra TPS has with other regular pacemakers is that it does not require ‘surgical pockets’ thereby eliminating potential causes of complications that ‘surgical pockets’ and leads could exacerbate. Additionally, the pacemaker is not easily visible.
While the device has a retrieval feature, it is meant to remain in the human body. Even if a patient requires another device, it can be turned off permanently without having to remove it and then another one implanted.
On Friday shares of Medtronic plc edged up by 0.30% to close the day at $83.04.
