New ALS Device Trial; The PARADIGM Study Will Continue Research Of The NeuRx® Diaphragm Pacing System (DPS) In ALS Patients
Synapse Biomedical Inc. (www.synapsebiomedical.com) announced today that it will be rolling out a new ALS trial for its NeuRx Diaphragm Pacing System (DPS). The PARADIGM study will look at the safety and benefit of on-label Humanitarian Device Exemption (HDE) use of the NeuRx DPS® in patients with ALS on non-invasive ventilation (NIV).
There have been 5 studies previously looking at the use of NeuRx DPS in ALS. Two smaller studies in Europe were stopped prematurely. Two larger US trials reported a survival benefit in ALS patients. The US studies, IDE (n=85) and PAS (n=60), showed a median post-implant survival of 19.7 and 21 months respectively. A third US study, the NEALS randomized-control trial, has not yet provided analysis of its data.
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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