Clinical Studies

Completed

Based on this study, consisting of 86 patients from 8 study centers, the U.S. FDA approved the NeuRx DPS^® under a Humanitarian Device Exemption (HDE) for use in people with ALS and symptoms of reduced breathing capability (chronic hypoventilation). The FDA reviewed the results of this clinical study and determined that the probable benefit to health from the use of the device outweighs the risk of injury or illness from its use in people who have ALS and reduced breathing capability and meet certain other criteria. This analysis of outcomes in the HDE study has been reviewed, audited and disseminated by the FDA in the Summary of Safety and Probable Benefit available on the FDA web site (http://www.accessdata.fda.gov/cdrh_docs/pdf10/H100006b.pdf).

Inclusion criteria:

• Age 18 or older
• Participants with familial or sporadic ALS diagnosed as laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria will be eligible
• Forced Vital Capacity (FVC) between 50 – 85% of predicted values at time of screening
• FVC greater than 45% of predicted value at time of surgery
• Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with EMG recordings and nerve conduction times
• No underlying cardiac or pulmonary diseases that would increase the risk of general anesthesia greater than the expected risk of the patient with ALS
• Negative pregnancy test in females of child-bearing potential

Results:

• IDE pivotal trial (N = 86, 8 study centers)
• The patients who used the NeuRx DPS^® plus non-invasive ventilation (NIV) survived 16 months longer (on average) than patients who just used NIV. This 16 month time frame is from the time of diagnosis. Survival time was measured until death or the need for a full time ventilator and a tube in the throat (tracheostomy).
• The patients who used the NeuRx DPS^® plus NIV survived 9 months longer (on average) than patients who just used NIV, when survival is measured from the initiation of NIV.
• Some patients had a feeding tube placed with the NeuRx DPS^®. All of these patients survived past 30 days.  Normally, 2 to 25 patients out of 100 (up to a fourth of all patients) would not survive this long.
• Some patients could not get used to or were unable to use NIV but used the NeuRx DPS^®. They survived an average of 16 months after getting the DPS.

Some patients had their sleep tested after using the NeuRx DPS^® for 4 months.  They tended to have better sleep than before they received DPS.

In Progress

In Progress

Post Approval Clinical Study Summary