Inspire MD Initiates Voluntary Field Action for Mguard Prime Embolic Protection Stent

Inspire MD Inc. has initiated a voluntary field action (VFA) following recent reports of Mguard Prime EPS (embolic protection stent) 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 the cobalt chrome EPS does not apply to or impact the company’s Mguard stainless steel EPS or Cguard nitinol products.

Inspire MD 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. The company has already begun notifying its clinical and commercial partners worldwide of the 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.

As a result of the VFA, Inspire MD has temporarily suspended enrollment in its MASTER II U.S. Food and Drug Administration (FDA) trial pending a review by the agency of the manufacturing improvements to the Mguard Prime EPS. This FDA review is likely to delay enrollment in the trial for approximately 3 to 6 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,” said CEO Alan Milinazzo. “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.”

The Israeli embolic stent company has its U.S. offices in Boston, Mass.