SUBSEQUENT EVENTS

3 Months Ended

Mar. 31, 2014

SUBSEQUENT EVENTS [Abstract]

SUBSEQUENT EVENTS

NOTE 12 - SUBSEQUENT EVENTS:

On April 30, 2014, the Company initiated a voluntary field corrective action ("VFA") of our MGuard Prime EPS to address the issue of stent retention following reports of MGuard Prime EPS stent dislodgements. To date, there have been no reports of any patients being harmed in these recent reports reviewed by the Company. The Company believ es that it has identified the root cause of these dislodgements and, upon approval from the European regulatory agency, intends to modify all existing units of the MGuard Prime EPS in order to improve stent retention and performance. The Company began notifying its clinical and commercial partners worldwide of its VFA and intends to modify all units in the field once regulatory approval is received. The VFA will have a short term impact on both the commercial and clinical activities relating to the MGuard Prime EPS. The Company anticipates regulatory review to be completed by the end of the current, second quarter and would then commence shipping MGuard Prime EPS back into the marketplace.

The expense associated with the VFA, which the Company expects to incur primarily during the second quarter of 2014, is currently estimated to be between $200,000 and $300,000.