The UK study has come under scrutiny from ALS experts in the US. They have questioned the study design and authors’ conclusions. The US experts argue that the UK results did not show pacing was harmful, rather that the use of DPS should be used in conjunction with NIV. The other European study, conducted in France studied newly diagnosed patients. This patient group would be considered off-label in the US.
“We have always maintained, diaphragm pacing is for a select group of ALS patients that already have chronic hypoventilation but have intact lower motor neurons with loss of upper motor neuron control,” commented Dr. Ray Onders Interim-Chair of Surgery and Remen Chair in Surgical Innovation at University Hospitals of Cleveland and Professor of Surgery at Case Western Reserve University. “This study reaffirms this position and further supports our FDA approved indication; ALS patients with documented chronic hypoventilation and clinical confirmation of intact phrenic nerves.”
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