NeuRx DPS, the world leading diaphragm pacing device, helping hundreds of pateints move away from mechanical ventilation, has been granted a new approval in the United States.
FDA has granted premarket approval (PMA) of the NeuRx® Diaphragm Pacing System (NeuRx DPS®) for use in patients with spinal cord injuries who rely on mechanical ventilation.
PMA is the most stringent type of device marketing application required by FDA, and basically it indicates that the FDA has cleared NeuRx DPS for use without the need for any of the lengthy internal review and approval process required under the previous humanitarian device exemption.
“This is a very big deal for our community,” said Jen French, executive director of the North American Spinal Cord Injury Consortium “It will improve access and affordability for people living with spinal cord injuries and give them the chance to live life without the restrictions imposed by a ventilator.”
The latest guidelines for Spine Injury issued by the American College of Surgeons, Diaphragm pacing states that Diaphragm pacing is beneficial
for the patient in these ways:
Helps improve respiratory mechanics (specifically spontaneous tidal volume)
Reduces weaning time and achieves independence from the ventilator, and
Potentially decreases hospital cost and length of stay.
It further advises surgeons to consider stimulation of the diaphragm in their long-term ventilation strategies.
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