Neuros Medical Inc. received Investigational Device Exemption approval from the FDA allowing it to commence a clinical trial to evaluate its Altius System High Frequency Nerve Block technology for the management of intractable limb pain in amputees.
The prospective, randomized, controlled pivotal clinical trial will consist of 130 patients at 15 institutions in the Unites States to evaluate the safety and efficacy of the Altius System. The results will support a premarket approval application to the FDA to market the device, according to a company press release.
Neuros Medical recently announced the results of a pilot study, in which more than half of study subjects stopped using their pain medications.
“We look forward to executing the next steps in the pivotal study process with the eventual goal of receiving approval to market the Altius System to provide long-term pain relief to those suffering from chronic amputation pain,” Jon J. Snyder, president and chief executive officer of Neuros Medical, stated in the release.