510(k) Clearance For NeuroMetrix SENSUS™ Pain Management Device

In short

NeuroMetrix, Inc., a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, announced that it has received 510(k) clearance for its SENSUS™ Pain Management device from the U.S FDA. The device is intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.

Background 

NeuroMetrix is a developer of home use and point-of-care devices, associated consumables, and support software for the treatment and management of diabetes and its complications. The company is focused on nerve related complications of diabetes, called diabetic neuropathies, which affect over 50% of people with diabetes. If left untreated, diabetic neuropathies trigger foot ulcers that may require amputation, cause disabling chronic pain, and increase the risk of falling in the elderly.

The annual cost of diabetic neuropathies has been estimated at $14 billion in the United States. The company’s products are used by physicians and other clinicians, in retail health settings such as pharmacies, and by managed care organisations to optimise patient care and reduce healthcare costs.

The company already markets the NC-stat® DPNCheck™ device, which it says 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.

SENSUS employs the same sophisticated nerve stimulation technology as the NC-stat DPNCheck device, and includes advanced features that NeuroMetrix believes may address the technical and clinical limitations of existing nerve stimulators. The device also includes technology to maximise patient compliance, which is one of the fundamental challenges with pain therapy.

The physiological principle is that excitation of normal nerves reduces transmission of pain signals to the brain. This may occur through inhibition of neurons in the spinal cord that transmit pain signals further up in the central nervous system. There is also evidence that supraspinal structures activate pain suppression pathways through release of opiod peptides and other neuromodulatory agents.

Company comments

“This product (Sensus) has attracted attention among health care providers because of its potential benefit to patients suffering from chronic pain,” said Shai N. Gozani M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. “FDA clearance keeps us on track to launch the SENSUS Pain Management System in the fourth quarter of 2012. We are particularly enthusiastic about adoption of the device by diabetes focused clinicians because a number of recent systematic literature reviews and meta-analyses have concluded that transcutaneous electrical nerve stimulation may be an effective and safe treatment for painful diabetic neuropathy.”

Source: NeuroMetrix, Inc., Business Wire