Neuros Medical, a US-based neurostimulation company, has obtained an investigational device exemption (IDE) clearance from the US Food and Drug Administration (FDA) to initiate a randomized, controlled pivotal clinical trial to evaluate the safety and efficacy of its Altius system.
This prospective, pivotal clinical trial will enroll 130 patients at 15 sites in the US for evaluating the Altius system high frequency nerve block technology for the management of intractable limb pain of amputees.
Results obtained from the pivotal clinical trial will support a premarket approval application to FDA to market the device.
Neuros Medical chief scientific officer Dr Zi-Ping Fang said: "Receiving the IDE approval from the FDA to move forward with our pivotal study is an important milestone in the development of our technology."
Recently, the company unveiled positive results from its long-term pilot study demonstrating significant pain reduction.
Additionally, over half of the patients discontinued their pain medication use during the long-term pilot study.
Neuros Medical president and CEO Jon J Snyder said: "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."