May 9, 2014 — InspireMD Inc. initiated a Voluntary Field Action (VFA) following recent reports of MGuard Prime EPS (embolic protection systems), stent dislodgements. These reports have primarily occurred during the preparation of the MGuard Prime EPS, 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. 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.
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.
As a result of the VFA, the company has temporarily suspended enrollment in its MASTER II FDA trial pending a review by the U.S. 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 three to six months. The company intends to focus on site activation during this review period in order to accelerate enrollment once the study resumes.
"We believed it was prudent to initiate this voluntary field action in order to proactively address the issue of stent retention and to uphold our strong commitment to quality," stated Alan Milinazzo, chief executive officer of InspireMD. "There will be a short-term impact on our revenue, as we have chosen to discontinue shipments of MGuard Prime while we work through the regulatory portion of this voluntary action. We also anticipate a delay of up to six months before resuming enrollment activities for the Master II FDA trial. The costs associated with upgrading the inventory of MGuard Prime units is minimal and should have little impact on our short term cash position. We view this action as a corporate responsibility and while it is a near-term setback, improving the quality of our product performance should result in long-term clinical and commercial benefits."
For more information: www.inspire-md.com