InspireMD Allowed to Restart EU Production of its MGuard EPS Stent

Boston-based InspireMD, a devicemaker specializing in embolism protection, said Monday that EU authorities have cleared the way for the company to resume production and distribution of the MGuard Prime embolic protection system stent.

InspireMD issued a voluntary field action for the device on April 30, after it received reports of stent dislodgements. The problem occurred during the preparation of the sent, upon removal of the protective sleeve or during withdrawal of the stent into the guide catheter, CEO Alan Milinazzo told Device Daily Bulletin.

There have been no reports of patients being harmed as a result of these dislodgements, Milinazzo said.

The field action included modifications to the manufacturing process for the MGuard EPS. InspireMD expects to restart production over the next several weeks. Existing stents will be modified and returned to the customer, the company said.

Milinazzo said the company is also working to resume a U.S. clinical trial to support FDA premarket approval of the device. InspireMD expects the agency to review the submission in the late third quarter or early fourth quarter of this year. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.