US-based medical device company Neuros Medical has enrolled the first patients in the pivotal clinical trial, to assess its patented Altius System High Frequency Nerve Block technology for the management of intractable limb pain of amputees.
The randomized and controlled pivotal clinical study will include around 130 patients at 15 institutions to assess the safety and efficacy of the firm’s Altius System.
The study principal investigator Dr Leonardo Kapural said: "The Neuros High Frequency Nerve Block has the opportunity to be a paradigm shift in treating chronic pain, especially post-amputation pain, due to its on-demand blocking effect, versus traditional stimulation."
The trail is being conducted to support FDA PreMarket Approval Application, which will allow the company to market the device.
Neuros noted that the pivotal trial is based on their long-term pilot study which reported significant pain reduction, up to 30 months.
Neuros Medical president and CEO Jon Snyder said: "We are excited to have our first implants underway as we execute our pivotal study, with our wave of sites commencing recruitment and enrolment."
The firms’ patented platform technology, Electrical Nerve Block will help in reducing chronic pain in a variety of conditions including amputation pain, post-surgical pain, migraine, and trigeminal neuralgia.