"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," according to a press release.
The move involves only the cobalt-chrome version of the device, not the MGuard stainless steel EPS or InspireMD’s CGuard nitinol products, according to the release. InspireMD said it’s temporarily suspended enrollment in the Master II FDA trial, "pending a review by the FDA of the manufacturing improvements to the MGuard Prime EPS."
The FDA review is expected to delay enrollment in the Master II trial for 3-6 months, InspireMD said.
"The company intends to focus on site activation during this review period in order to accelerate enrollment once the study resumes," according to the release.
"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," CEO Alan Milinazzo said in prepared remarks. "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."
InspireMD said it "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 anticipates regulatory review to be completed by the end of the current, 2nd quarter and would then commence shipping MGuard Prime EPS back into the marketplace," according to the release.
InspireMD said it began notifying clinical and commercial partners about the problem and "intends to modify all units in the field once regulatory approval is received."