FDA Approves Wireless Pacemaker
There’s a new twist on an old invention that was, itself, once thought to be a medical miracle.
On Wednesday, the Federal Drug Administration (FDA) approved use of Medtronic Plc's wireless pacemaker in the U.S., making it the first pacemaker that does not need wired leads to correct slow heart rate.
Traditional pacemakers are small devices that are placed in the chest or abdomen to help control abnormal heart rhythms. They use low-energy electrical pulses to prompt the heart to beat at a normal rate.
This new pacemaker is delivered to the heart chambers through a patient's arteries by means of a catheter. It’s a huge improvement over traditional pacemakers, which are implanted through an incision and connected to the heart with a wired lead to send electrical pulses to correct heart rate.
In order to give the go-ahead to this revolutionary device, the FDA evaluated data from a 719-patient clinical trial that found that 98% of patients had a stable heart pacing 6 months after the device was implanted.