![]() ![]() Reason of Field Safety Corrective Action:įollowing recent complaints of MGuard Prime EPS dislodgements, InspireMDhas announced a Voluntary Field Safety CorrectiveAction. The diameter and length of each item is provided in the attached letter Implants, Non Active, Coronary Artery Stents. We believe the CGuard and the associated CARENET trial will be of great interest to physicians treating patients with carotid artery disease worldwide.MGuard Prime Coronary Stent System Embolic Protective Stent (EPS) Milinazzo continued, “We remain on track to complete enrollment in the CARENET study and interest among physicians here at EuroPCR remains very high. The size, or aperture, of the MicroNet ‘pore’ is only 150-180 microns in order to maximize protection against plaque and thrombus. This protects patients from plaque debris and blood clots breaking off and traveling distally in the arteries which can lead to life threatening strokes. The proprietary CGuard carotid EPS uses the same patented MicroNet™ technology featured on its MGuard Prime™ coronary system. InspireMD will also be speaking with investigators about the CARENET (CARotid Embolic protection study using microNET) multi-center European clinical trial using the CGuard™ carotid embolic protection system (“EPS”). “We look forward to sharing this information with the European cardiology community for the first time at EuroPCR and we anticipate a similarly positive reception.” “When we presented the MASTER I trial findings in Q4 in the United States, they were extremely well received, as the data suggested that InspireMD’s MGuard EPS offers STEMI patients a higher likelihood of survival at 12 months than standard bare metal and drug eluting stents,” stated Alan Milinazzo, President and Chief Executive Officer of InspireMD. The secondary endpoint continued to show lower mortality rates with MGuard use as opposed to the control group. Further, the MASTER trial achieved its primary endpoint in complete ST-segment resolution at 60-90 minutes post-procedure, which is historically a strong predictor of mortality. Throughout the meeting, presenters will discuss data from InspireMD’s 12-month MASTER (MGuard for Acute ST Elevation Reperfusion) trial demonstrating that the MGuard outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients. 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. Company to Present at European Symposium Titled MGuard™ Embolic Protection Stent: The Importance of Thrombus Management in STEMI Primary PCIīOSTON, MA – InspireMD, Inc. ![]()
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