Release date: 2015-04-20
Recently, Medtronic announced that the company's development of the world's smallest pacemaker Micra TPS has obtained CE certification, which is based on a safety and effectiveness evaluation study involving 60 patients. The Micra TPS Global Clinical Trial (MTGC) is still underway and will recruit 780 patients from 20 countries in 50 clinical centers.
The preliminary findings of the MTGC will be presented at the Heart Rhythm Society's 2015 Annual Scientific Sessions in May. Although the Micra TPS has not been approved by the FDA, it has been implanted in the initial patient.
The Micra TPS is only half the size of a 25-cent coin, 24 mm long and 0.75 cubic centimeter in size, which is only one-fifth the size of a traditional pacemaker. In addition, the Micra TPS battery can operate at full load for 8 to 10 years.
As the only test site in the Northwestern United States, the Providence St. Vincent Medical Center has successfully completed three implants. On November 6, 2014, 76-year-old Bill Pike implanted the Micra TPS at the St. Vincent Medical Center in Providence, USA, and walked the next day.
According to Dr. Randy Jones, who is responsible for Pike, the Micra TPS is about the same time as a typical pacemaker, about 40 minutes. However, when surgically implanted, Micra TPS is implanted from the shoulder or chest like a traditional pacemaker, but in a minimally invasive manner, the blood vessels in the leg enter the heart and attach to the heart muscle, with minimal risk of infection. .
In addition, traditional cardiac pacemakers need to be connected to the heart via electronic leads, sometimes causing them to fall off; Micra TPS uses a leadless design with a built-in wireless synchronous pacing device to reduce electrode complications.
About cardiac pacemaker
A pacemaker is a pocket-sized electronic therapy device that is implanted directly into the patient's chest. The device monitors the patient's heart rate 24 hours a day. Once the patient's heart rate is abnormal (too fast or too slow), pacing is achieved. The device will automatically correct the abnormal heart rate in a dozen seconds by the doctor's pre-set treatment plan, so that it will resume normal beating.
The world's first artificial pacemaker was born in the United States and was invented by the chest surgeon Hyman in 1932. In Sweden in 1958, Dr. Rune Elmqvist designed an implantable pacemaker with a circular shape and two series of nickel-cadmium batteries as energy sources. In the United States in 1960, Wilson Greatbatch successfully implanted a pacemaker with zinc-mercury batteries as an energy source for patients. Since then, pacemakers have entered the era of implantable artificial cardiac pacemakers.
As an electronic therapeutic instrument implanted in the body, the implantable cardiac pacemaker is easy to be accepted by doctors and patients during clinical operation because of its simple installation, small trauma, light pain and remarkable curative effect. Clinical applications have saved the lives of tens of thousands of patients for more than 50 years.
Source: Bio-Exploration
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