[Dysphagia] e-stim for swallowing

[kcopeland at sjmc.org (Copeland, Karen)]

Do they hold the patents? Or have the patents just been "applied for"?
There is a big difference


Karen Copeland
Therapy Coordinator, Bernsen Rehabilitation
St. John Medical Center
918-744-2291
kcopeland@sjmc.org
**************************************
"No snowflake ever falls in the wrong place." ~Zen saying


-----Original Message-----
From: dysphagia-bounces@b9.com [mailto:dysphagia-bounces@b9.com] On
Behalf Of Casper219@aol.com
Sent: Tuesday, February 28, 2006 11:42 PM
To: dysphagia@b9.com
Subject: [Dysphagia] e-stim for swallowing

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
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