InspireMD Announces Voluntary Field Action for MGuard Prime EPS

April 30, 2014—InspireMD, Inc. announced that it has initiated a voluntary field action (VFA) following recent reports of stent dislodgements with the company’s MGuard Prime embolic protection system (EPS). These reports have primarily occurred during the preparation of the device, upon removal of the protective sleeve, or during withdrawal of the MGuard Prime EPS into the guide catheter. To date, there have been no reports of any patients being harmed in these recent reports reviewed by the company.

The VFA for InspireMD’s MGuard Prime cobalt chrome EPS does not apply to or impact the company's MGuard stainless steel EPS or CGuard nitinol products.

The company believes 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. On April 30, InspireMD began notifying its clinical and commercial partners worldwide of its VFA for the MGuard Prime EPS and intends to modify all units in the field once regulatory approval is received.

According to InspireMD, 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 second quarter of 2014 and it would then commence shipping MGuard Prime EPS back into the marketplace.

As a result of the VFA, InspireMD has temporarily suspended enrollment in its MASTER II trial pending a review by the US Food and Drug Administration (FDA) of the manufacturing improvements to the MGuard Prime EPS. This agency review is likely to delay enrollment in the trial for approximately 3 to 6 months. The company intends to focus on site activation during the review period in order to accelerate enrollment once the study resumes.