FDA Approves Medtronic Device, Billed as World's Smallest Pacemaker
April 06 2016 - 6:27PM
Dow Jones News
By Josh Beckerman
A Medtronic PLC device that the company calls the world's
smallest pacemaker received U.S. Food and Drug Administration
approval.
The inch-long device, called Micra, is implanted directly in the
right ventricle chamber of the heart. It works like other
pacemakers but doesn't require wired leads to provide an electrical
connection. It is the first approved "leadless" pacemaker, the FDA
said.
The Micra system delivers electrical impulses through an
electrode at the end of the device, and it is intended to treat
heart arrhythmias including atrial fibrillation.
In November, Medtronic said the pacemaker met safety and
effectiveness goals in a clinical trial by wide margins. At the
time, Medtronic said it was "extremely pleased with the remarkably
successful implant rates and safety profile." The company said
patients receiving the device had a significantly lower level of
major complications than patients with conventional pacemaker
systems.
The device received the CE Mark in Europe a year ago.
On March 1, Medtronic reported a 12% growth in net income in its
fiscal third quarter, while a strong U.S. dollar and
weaker-than-expected sales of some products pressured the company's
revenue and operating margins.
The earnings report was the fourth since the $43 billion
purchase of Covidien in an inversion deal.
On Wednesday, after proposed regulations on inversions led to
the collapse of Pfizer Inc.'s planned $150 billion deal with
Allergan PLC , Medtronic said the regulations won't have a material
financial impact on the company.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
April 06, 2016 18:12 ET (22:12 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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