The last time we covered NeuroMetrix, Inc., it was the news that its SENSUS Pain Management System had become the first transcutaneous electrical nerve stimulator to receive FDA 510(k) clearance for use during sleep.
Now the company tells us it has commenced shipments of the second generation of its wearable therapeutic technology, the SENSUS™ Pain Management System.
The SENSUS device is designed for people with diabetes that suffer from chronic pain. The most common cause of such pain is painful diabetic neuropathy (PDN), which affects up to 5 million people in the U.S. alone. Additional forms of chronic pain that may benefit from transcutaneous electrical nerve stimulation include fibromyalgia, post herpetic neuropathy (shingles), and conditions with both chronic pain and disturbed sleep such as restless leg syndrome.
SENSUS technology utilizes comfortable, non-invasive electrical nerve stimulation of sensory nerves to induce a safe and effective elevation in the level of naturally occurring neuromodulatory chemicals, called enkephalins, which block the transmission of pain signals throughout the nervous system. As a result, many patients experience fast-acting, non-narcotic relief from chronic pain when using the device.
Classed as a transcutaneous electrical nerve stimulator, SENSUS has broad regulatory indications for management of chronic pain and is the only such device cleared by the FDA specifically for use during sleep as we reported last year. The device is lightweight and can be worn during the day while remaining active, and at night while sleeping. It incorporates a tri-axial MEMS accelerometer that monitors patient body position and movement enabling automatic regulation of therapeutic parameters.
The second-generation SENSUS builds on the successful launch of the technology in early 2013. Over 2000 first generation devices have shipped since launch. The second-generation device is about 20% thinner and has several key hardware improvements. The thinner design makes the device more discreet when worn under clothing and more comfortable during sleep.
“The launch of our second generation SENSUS device demonstrates our scientific capabilities in wearable medical technology and commitment to continual innovation. Feedback from patients and physicians on the over 2000 first generation devices in use has been positive and provided us with a road-map for further improvements, many of which are incorporated into the second generation device,” said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. “In addition to the use of SENSUS in managing chronic pain, the novel integration of electrical stimulation and activity tracking through the embedded accelerometer offers exciting opportunities to develop wearable therapeutic devices for a variety of medical conditions.”
Source: NeuroMetrix, Inc., Business Wire