MDT Medtronic PLC

By Jeanne Whalen 

The U.S. Food and Drug Administration approved a new pacemaker for the heart that doesn't require the use of wires that can sometimes cause complications.

The inch-long device from Medtronic PLC, called Micra, uses small prongs to attach directly to the heart, where it delivers electrical pulses that help the heart beat more regularly. Older pacemaker devices are implanted under the skin near the collarbone and are hooked to the heart by one or more wires that are fed through the veins.

Those wires, sometimes called leads, can break or grow infected, causing complications and the need for extra procedures.

"As the first leadless pacemaker, Micra offers a new option for patients considering a single chamber pacemaker device, which may help prevent problems associated with the wired leads," William Maisel, acting director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in a statement.

The FDA said Micra is intended for patients with irregular heartbeats such as atrial fibrillation or bradycardia-tachycardia syndrome.

In a clinical trial funded by Medtronic and published last year in the New England Journal of Medicine, 725 patients were implanted with a Micra device. After six months about 98% of them had adequate heart pacing. According to the paper, there were major complications in 25 patients, including cardiac injuries and blood clots.

No patients in the study received older pacemakers for the sake of comparison. After the study was completed the researchers compared the Micra's rates of complication with those of older pacemakers in other studies and found that Micra patients had "significantly fewer major complications," according to the study results.

The Micra is implanted through a thin tube inserted in a vein in the patient's groin. The vein leads to the heart, where the pacemaker is affixed to the inside of the right ventricle of the heart. The Micra paces only the lower chambers of the heart and is therefore not suited for all patients, some of whom need pacing in the upper and lower chambers, according to John Hummel, a cardiologist and medical professor at Ohio State University who helped conduct the trial published in the New England Journal of Medicine.

He said other wireless pacemakers are being developed that would work in the upper and lower chambers of the heart. The Micra "represents the threshold of a future of leadless pacemakers," he said.

Apoor Patel, a cardiologist at North Shore University Hospital in New York, a unit of Northwell Health, said he is optimistic the Micra can "reduce some of the complications associated with traditional devices."

In a statement, Medtronic said it was pleased "to be the first to introduce a transcatheter pacemaker to patients in the U.S."

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.

Josh Beckerman contributed to this article.

Write to Jeanne Whalen at jeanne.whalen@wsj.com

(END) Dow Jones Newswires

April 06, 2016 20:49 ET (00:49 GMT)

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