NeuroMetrix,
Inc. (NURO),
a medical device company focused on the treatment of the neurological
complications of diabetes, reported that the SENSUS Pain Management
System became the first transcutaneous electrical nerve stimulator to
receive 510(k) clearance (K130919) from the U.S. Food and Drug
Administration (FDA) for use during sleep.
SENSUS is a convenient and wearable non-invasive device that offers
physicians and their patients a non-narcotic pain relief option as a
complement to medications. The device is lightweight and can be worn
during the day while remaining active. It is the only transcutaneous
electrical nerve stimulator designed specifically for people with
diabetes and chronic pain. The most common cause of such pain in people
with diabetes is painful diabetic neuropathy (PDN), which affects up to
5 million people in the US alone. About half of patients with PDN suffer
from sleep disturbances, which can aggravate their diabetes. With this
expanded regulatory indication, the device may now be marketed for
overnight use.
Under its draft guidance on transcutaneous electrical nerve stimulators
for pain relief, the FDA requires that these devices carry a warning
against use during sleep, primarily because of electrical hazards
following dislodgement of electrodes. SENSUS utilizes a proprietary
electrode peeling detection algorithm to address this risk.
“SENSUS is the first and only transcutaneous electrical nerve stimulator
that specifically includes use during sleep within its 510(k)
indications,” said Shai N. Gozani, M.D., Ph.D., President and Chief
Executive Officer of NeuroMetrix. “We believe that growing recognition
of the inter-relationship between chronic pain, such as painful diabetic
neuropathy, and sleep disturbances is clinically important and
represents a unique market position for SENSUS. We will build on this
expanded indication by launching a series of novel sleep enabling
features for SENSUS over the next 12 months.”
About NeuroMetrix
NeuroMetrix is a medical device company that develops and markets home
use and point-of-care devices for the treatment of diabetic
neuropathies, which affect over 50% of people with diabetes. If left
untreated, diabetic neuropathies trigger foot ulcers that may require
amputation and cause disabling chronic pain. The annual cost of diabetic
neuropathies has been estimated at $14 billion in the United States. The
company markets the SENSUS™ Pain Management System for
treating chronic pain, focusing on physicians managing patients with
painful diabetic neuropathy and similar peripheral neuropathies. The
company also markets the NC-stat® DPNCheck®
device, which is a rapid, accurate, and quantitative point-of-care test
for diabetic neuropathy. This product is used to detect diabetic
neuropathy at an early stage and to guide treatment. For more
information, please visit http://www.neurometrix.com.
Copyright Business Wire 2013