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FDA Approves Portable Breathing Pacemaker NEW YORK, NY -- March 9, 1998 -- The Food and Drug Administration has given marketing approval to a new breathing pacemaker for patients who have lost neurological control of respiration. The portable device can significantly improve the quality of life and dramatically reduce the cost of care of people who are dependent on mechanical ventilators, including those with brain-stem or spinal cord injuries or with sleep apnea. The Mark IV pacemaker was developed by the Dobelle Institute through its affiliates on Long Island and in Switzerland. The pacemaker controls breathing by delivering repetitive electrical impulses to the phrenic nerves, which control movement of the diaphragm. Implantation of the device takes about an hour and can be performed on an outpatient basis. Two patients implanted at Columbia-Presbyterian are among the first in the United States to receive the new system. One of the recipients is a seven-year-old boy who has had sleep apnea since birth and stops breathing whenever he falls asleep. Another recipient is a retired telecommunications professional, age 64, who had a small stroke in 1996 and suffers from intractable hiccups, which interrupt his breathing thousands of times a day. A third patient, age 33, was paralysed from the neck down in a 1993 wrestling accident. After initial implant surgery, in Virginia, he came to Columbia-Presbyterian for pacemaker tuning at the Dobelle Institute. The Mark IV completely supersedes earlier versions of the device, which affiliates of the Dobelle Institute have been making since 1971. Patients in 24 foreign countries have been using the new system during the FDA review, through the Institute Dobelle AG of Zurich. Most patients implanted with the earlier models can now be upgraded to the Mark IV without surgery. In the future, by changing electrodes and the nerves selected for stimulation, the device will also be used to control many types of intractable pain, movement disorders such as Parkinson's disease, urinary incontinence and male sexual dysfunction. The Mark IV is the direct outgrowth of ongoing research into artificial vision for the blind (TV camera and computer connected to the brain), conducted by Dr. Dobelle and his collaborators, beginning in 1968 at the University of Utah. E-mail this page to a friend or colleague! To print, use this version