Medtronic, Inc. (MDT) recently received the U.S. Food and Drug Administration (FDA) Neurological Devices Panel’s approval for its Deep Brain Stimulation (DBS) Therapy for Epilepsy. The DBS therapy can be used for treating epilepsy in patients who have continued seizures. This is an alternative to presently available epilepsy treatments.
The panel recommendation was based on data from SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) clinical trial in the U.S. The trial enrolled 110 patients from 17 U.S. trial centers who had severe epilepsy for an average of 22 years prior to study enrollment. Successful clinical data had resulted in the panel voting seven to five in favor of approving the product.
It has been seen that epilepsy affects the normal working life of a patient. Per the Epilepsy Foundation, epilepsy and seizures affect more than three million Americans of different ages. This results in an estimated annual direct and indirect cost of $12.5 billion.
If the FDA follows the recommendation of the panel, the product approval will be a shot in the arm for Medtronic as it will boost its Neuromodulation segment revenues.
Medtronic’s DBS therapy is presently approved by the FDA for treating advanced Parkinson’s disease and the disabling symptoms of essential tremor. It can be also used for treating dystonia, and chronic, severe, treatment-resistant obsessive-compulsive disorder under a Humanitarian Device Exemption (HDE).
Medtronic is one of the world’s leading medical technology companies, specializing in implantable and interventional therapy devices and products. The company’s main competitors include St. Jude Medical (STJ) and Boston Scientific Corp. (BSX).
Currently, we are Neutral on Medtronic.
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