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FDA Grants Approval for Alternative to Ventilators: Implantable Device That Stimulates Breathing

Friday, June 20, 2008 at 4:00 AM

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Breathing: you do it when you're sleeping, when you're eating, while talking or laughing, and most of the time you never give it a second thought. But for patients with the neurodegenerative disease ALS or some spinal cord injuries - breathing is something a machine has to do for them. As ideastream Health and Science Reporter Gretchen Cuda explains, one Ohio company will soon be helping patients around the country breathe a little easier.

To say that existence on a ventilator is a drag, is well, an understatement.  Ventilators are loud, hard to move around, and always plugged into the nearest power outlet.  They prevent patients from traveling, and in some cases from leaving the hospital or their homes.  They disrupt speech, and impair the sense of taste and smell.  And they cost a lot, explains Anthony Ignagni of Synapse Biomedical.

IGNAGNI:  We had a patient - he was in the ventilator ward, cost 16 thousand dollars a month to Ohio Medicaid.  After weaining off the ventilator using our device, in 7 weeks he moved over 1 hallway in the facility and his cost went to 3 thousand dollars a month.  That’s a 13 thousand dollar a month savings to Ohio Medicaid.  He then moved home and now is married and working.

The device that transformed that patients life has just received FDA approval.  It’s eliminated the need for a ventilator in 50% of the patients who have tried it - and reduced the dependence on ventilators for 98%.  Dr. Ray Onders of University Hospitals is the surgeon who has implanted the Diaphram Pacemaker System in clinical trials.

ONDERS: We’ve been able to develop a technique through laproscopic surgery, you know the minimally invasive surgery through your belly button where we put electrodes on the diaphragm and these electrodes will cause the diaphragm to contract and that allows patients to breathe the same way they were breathing before their injury.

Cutting the costs of the equipment and specialized care alone, allows patients to participate in treatment programs and hospital settings they would otherwise be turned away from.  And many who have tried the system ... well, Dr. Onders explains it best.

ONDERS:  We have a patient that says once they’re off “I’m never going back.  If this doesn’t get FDA approval and you abandon this, I’d rather die.”

The FDA approval is currently for adult spinal cord patients only, but the company is seeking to extend the use of the device to pediatric patients and patients with Lou Gehrig’s Disease, otherwise known as ALS.  Gretchen Cuda 90.3

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