[Dysphagia] e-stim for swallowing

[Casper219 at aol.com (Casper219@aol.com)]

Not trying to attack or even make comment about this approach to treatment 
but only to clarify here - the FDA gave VitalStim "clearance to market".  This 
means that their device is essentially the same as all other devices that do 
the same thing so they are allowed to sell it as an e-stim device.  VitalStim 
has INDICATION (one) listed on the FDA clearance to market that is to treat the 
pharyngeal muscles of swallowing.   Other e-stim devices have WARNINGS against 
placement of electrodes on the anterior neck, meaning the clinician needs to 
seriously consider whether or not to do it, not that it can never be done 
(that would be listed as a contraindication).  Other e-stim devices do not specify 
a muscle or muscle group, but have more general indications for use with 
neuromuscular re-education, edema control, etc.  To say VitalStim is APPROVED by 
the FDA is misleading and can get the company into trouble if they make that 
claim.  They have not been through the rigors required for approval, only 
clearance to market.  The FDA says nothing about effectiveness nor for which 
populations the device can be used.  
VitalStim also holds 5 patents on their device and method, which includes 
discussion of many disorders they make treatment claims for, beyond dysphagia.  
Mary