FDA Approves Medtronic Device, Billed as World's Smallest Pacemaker

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 [e-mail]

(END) Dow Jones Newswires

April 06, 2016 18:15 ET (22:15 GMT)

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