InspireMD announced that the FDA has approved the company's submitted Investigational Device Exemption (IDE) amendment for 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).
InspireMD said while patient enrollment in the US MASTER II trial has been discontinued, which was intended to support this IDE application, the FDA’s approval of the IDE amendment is an important endorsement of the process changes.
"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."
The company received European regulatory approval for these process changes in June, and now believes all returned MGuard Prime EPS inventory has been successfully modified and returned to direct hospital customers and the majority of their distributors.
As such, the Company resumed full commercial activities in direct markets in Western Europe as of mid-October and expects direct and distributor based selling to ramp up throughout the fourth quarter of 2014.
As previously announced, in light of current market conditions moving toward drug eluting stent (DES) adoption and the delay in enrollment due to the FDA review process, the Company revised its MGuard strategy for the US.
This included the decision not to resume enrollment in the MASTER II trial for the primary endpoints of ST segment resolution and death and target vessel re MI. This decision will allow the Company to direct more resources to the DES program and commercial activities for the MGuard and CGuard.
The Company successfully enrolled 310 patients in the MASTER II trial prior to suspending enrollment in April due to the product manufacturing process changes that were just approved by the FDA.
The initial clinical analysis of these 310 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.
InspireMD seeks to utilize its proprietary MGuard with MicroNet technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.