Choronary mguard prime mgp40286/14/2023 ![]() The symposium will focus on the importance of thrombus management in primary PCI for STEMI patients, provide an update on relevant clinical data on device selection in STEMI treatment and showcase real-life examples of how device selection can influence the outcome of STEMI patients. This event allows attendees to discover new products and R&D projects as well as interact with practitioners and industry partners to further development and innovation in the cardiovascular field.ĭuring the event, InspireMD will share the results of its 12-month follow-up from its MASTER Trial for the first time in Europe at a symposium titled “MGuard Embolic Protection Stent: The Importance of Thrombus Management in STEMI Primary PCI,” which will be attended by world-renowned faculty. The conference will take place in Paris, France from May 20-23, 2014.Įach year, more than120 companies from the cardiovascular industry, including device and equipment manufacturers, attend EuroPCR. (“InspireMD” or the “Company”), a leader in embolic protection systems, today announced that it will be attending EuroPCR 2014, the leading cardiovascular event in Europe. 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."įor more information about InspireMD and its offerings, visit Source: InspireMD, Inc.Company to Present at European Symposium Titled MGuard™ Embolic Protection Stent: The Importance of Thrombus Management in STEMI Primary PCIīOSTON, MA – InspireMD, Inc. 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 also anticipate a delay of up to six months before resuming enrollment activities for the Master II FDA trial. ![]() "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 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," stated Alan Milinazzo, Chief Executive Officer of InspireMD. The Company intends to focus on site activation during this review period in order to accelerate enrollment once the study resumes. This agency review is likely to delay enrollment in the trial for approximately 3 to 6 months. The Company anticipates regulatory review to be completed by the end of the current, second quarter and would then commence shipping MGuard Prime EPS back into the marketplace.Īs a result of the VFA, the Company has temporarily suspended enrollment in its MASTER II FDA trial pending a review by the FDA of the manufacturing improvements to the MGuard Prime EPS. The VFA will have a short term impact on both the commercial and clinical activities relating to the MGuard Prime EPS. Today, InspireMD began notifying its clinical and commercial partners worldwide of its VFA for the MGuard Prime EPS and intends to modify all units in the field once regulatory approval is received. ![]() The Company 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 VFA for InspireMD's MGuard Prime cobalt chrome EPS does not apply to or impact the Company's MGuard stainless steel EPS or CGuard nitinol products. To date, there have been no reports of any patients being harmed in these recent reports reviewed by the Company. 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. BOSTON, /PRNewswire/ - InspireMD, Inc. ("InspireMD" or the "Company"), a leader in embolic protection systems (EPS), today announced that it has initiated a Voluntary Field Action (VFA) following recent reports of MGuard Prime EPS stent dislodgements.
0 Comments
Leave a Reply. |