FDA Approves Breathing Pacemaker
The Food and Drug Administration has approved marketing of an improved version of a breathing pacemaker. The device stimulates breathing in people who have lost control of respiration.
The Mark IV pacemaker was developed by the Dobelle Institute at Columbia-Presbyterian Medical Center in New York. As part of the FDA trial, the pacemaker was already installed in 24 people, the developers said Monday. The FDA approved of the device on March 3.
One of the trial patients in the United States is a seven-year-old boy who, without a mechanical ventilator, would stop breathing as soon as he fell asleep, they said.
Another recipient is a 64-year-old man who has had intractable hiccups since a stroke in 1996. The hiccuping, thousands of time a day, interrupts his breathing.
The Mark IV device, which costs about $50,000 a unit, differs from earlier models in that it controls the body's two phrenic nerves and hemidiaphragms independently, rather than in unison.
The phrenic nerve is generally known as the nerve that activates the diaphragm, which in itself aids respiration by moving up and down.
The diaphram is made up of two hemidiaphragms that are each motored by their own nerve supply, and normally can function independently.
The external part of the device is a small flat box which can be attached to a belt. It sends signals to antennae attached to the patient's chest. A small radio receiver implanted inside the patient then passes the signal to electrodes on the phrenic nerves.
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