Maker of Embolic Protection Systems (EPS), InspireMD, Inc., tells us the FDA has approved certain manufacturing process changes to the MGuard Prime EPS that were proposed in response to the Company’s April 30, 2014 Voluntary Field Action (VFA). The changes were made under the requirements of the US MASTER II IDE trial which has subsequently been discontinued, although the company points to the FDA’s approval of the IDE amendment as an important endorsement of the process changes.
The MGuard Prime EPS is integrated with a precisely engineered micro net mesh that is designed to prevent the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage from breaking off. The device is CE mark approved and InspireMD had received European regulatory approval for the process changes back in June. The Company resumed full commercial activities in direct markets in Western Europe as of mid-October.
Regardless, the company has changed tack, at least in the U.S., pointing to the move towards Drug-Eluting Stents(DES) as one reason for revising its MGuard strategy. It will not now resume enrollment in the MASTER II trial for the primary endpoints of ST segment resolution and death and target vessel re MI, a decision it says will allow it to direct more resources to its own DES program, while continuing commercial activities for the MGuard and CGuard.
The MASTER II trial had successfully enrolled 310 patients, prior to enrollment being suspended. The initial clinical analysis of these patients at 30 day follow up showed encouraging clinical results in the MGuard group versus the control group. The Company will continue to follow these 310 MASTER II patients for one year from time of enrollment, and expects to report 30 day data at a major medical meeting in the first quarter of 2015.
“The FDA approval of the amendment to our MASTER II IDE further validates the safety of our manufacturing process changes to our MGuard Prime EPS,” commented Alan Milinazzo, CEO of InspireMD. “Along with the European approvals of our process changes, the rigorous review of the FDA should provide an extra level of confidence to our physicians worldwide.”
Source: InspireMD, Inc., PR Newswire