Fwd: FDA....
James Lubin (jlubin(AT)eskimo.com)
Thu, 12 Mar 1998 18:23:07 -0800
>
> Resent-Date: Mon, 9 Mar 1998 07:58:38 -0800
> Date: Mon, 09 Mar 1998 10:59:41 -0500
> From: Maxim Bily
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> To: Spinal Cord Injury ,
> Spinal Cord Injury Peer Net
> Subject: FDA....
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> FDA Approves Marketing of New
> Breathing Pacemaker
>
>
>
> NEW YORK, March 9 /PRNewswire/ -- 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 Dobelle Institute,
> a biotechnology company, is based at
> Columbia-Presbyterian Medical Center.
>
> 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 paralyzed 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.
> Columbia-Presbyterian, through its collaboration
> with the Dobelle Institute, is now the world's
> most active center for the implantation of
> breathing pacemakers.
>
> 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. "The new
> model is like an air-conditioned, four-wheel-drive
> Mercedes, while the older pacers ranged from a
> Model T Ford to a Volkswagen Beetle," says a
> Swedish patient, Anders, who has used both
> systems.
>
> Most patients implanted with the earlier models
> can now be upgraded to the Mark IV without
> surgery.
>
> The Institute's breathing pacemakers are the only
> ones to meet FDA standards for safety and
> efficacy.
>
> 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.
>
> The Dobelle Institute, a privately owned
> corporation, is entirely supported by the sale of
> neurological pacemakers and does not accept
> funds from foundations or government agencies
> or venture capital from investors. The Institute is
>
> led by William H. Dobelle, Ph.D., a former
> member of the Department of Surgery at
> Columbia-Presbyterian Medical Center. He also
> served as Director of the Division of Artificial
> Organs and Director of the Organ Bank. The
> Dobelle Institute was one of the first companies
> in Columbia University's biotechnology business
> incubator, the Mary Woodard Lasker Research
> Building, located in the Audubon Biomedical
> Science and Technology Park. The Lasker
> Building, the only site of its kind in New York
> City, opened in 1995 and now houses 16
> technology companies.
>
> --
> Maksim (Max) Bily
>
> mail to: imax(AT)odyssee.net
----
Jim Lubin jlubin(AT)eskimo.com
Bothell, WA, USA <http://www.eskimo.com/~jlubin>
disAbility Resources: <http://www.eskimo.com/~jlubin/disabled>