Based on reports of MGuard Prime EPS stent dislodgements InspireMD (NSPR -12.7%) initiates a Voluntary Field Action (VFA). The problems have allegedly occurred during the preparation of the device, upon the removal of the protective sleeve or during the withdrawal of the device into the guide catheter.
The company believes it has identified the cause of the problems and will modify all existing units of the CE Mark-designated device after the approval of European regulators. Products already shipped will be modified in the field. Shipments to European customers should restart in Q2.
Enrollment in the MASTER II U.S. clinical trial is suspended pending the FDA's review of manufacturing improvements to the MGuard Prime EPS. The delay will likely be three to six months.
Management says the costs to upgrade the products and delay the clinical trial are modest and will have minimal effect on the company's cash position.