OBERLIN, Ohio, Oct. 4, 2016 /PRNewswire/ -- 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."
The PARADIGM study will compare patients on NIV to patients that initiate NIV and elect to have the new NeuRx DPS® implanted. Additionally, the investigators will use a virtual control arm as a second comparator. The virtual control is based on an advance predictive model, developed by Origent Data Sciences, and has created a lot of interest among researchers.
"We are encouraged by the previous US study results in ALS and believe there is a place for this technology," stated Dr. Miller. "The PARADIGM study will be unique in that we will be comparing the survival of patients on non-invasive ventilation (NIV) who receive DPS to patients on NIV without DPS, historical controls, and virtual controls. We hope to determine which ALS patients will benefit the most from the technology and how to best incorporate this into our treatment algorithm."
Please contact Synapse Biomedical directly (440-774-2488 ext. 137) or via email at firstname.lastname@example.org to find a participating study site near you.
About NeuRx DPS® Technology
The NeuRx DPS® received FDA approval for ventilator dependency from spinal cord injury on June 17, 2008. The NeuRx DPS® was approved September 28, 2011 by the FDA for treating chronic hypoventilation from ALS. The NeuRx DPS® has demonstrated that it can help people with ALS live longer and sleep better than the current standard of care alone. For more on current indications for use, visit www.synapsebiomedical.com/products/patientInfo.shtml
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SOURCE Synapse Biomedical Inc.