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April 6 (Reuters) - Medtronic Plc’s wireless pacemaker was approved by the U.S. Food and Drug Administration on Wednesday, making it the first pacemaker in the United States that does not need wired leads to correct slow heart rates.
The Micra pacemaker is delivered to the heart chambers through arteries using a catheter, unlike traditional pacemakers that are implanted through an incision and connected to the heart with a wired lead.
The Micra pacemaker works without using a lead wire, eliminating the serious complications that can arise once the implanted leads wear out or get infected.
The FDA evaluated data from a clinical trial involving 719 and found that 98 percent of patients had a stable heart pacing for at least six months after the device was implanted, the health regulator said in a statement. (1.usa.gov/23iwftQ)
Less than 7 percent of the patients implanted with the device showed complications such as prolonged hospitalizations, blood clots in the legs and lungs and heart injury, the FDA said.
The MRI-safe Micra pacemaker was approved in the Europe in 2015.
St.Jude Medical Inc received European approval for its MRI-compatible leadless pacemaker in March.
MRI scans generate powerful radiations and patients with pacemakers are advised not to undergo the procedure.
Medtronic’s shares closed up 2 percent at $77.31 on the New York Stock Exchange on Wednesday. They were up less than a percent in extended trading. (Reporting by Rosmi Shaji in Bengaluru; Editing by Don Sebastian)
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