![]() History of cerebrovascular accident or transient ischemic attack within the last 6 months, or any permanent neurologic deficit.Concurrent medical condition with a life expectancy of less than 12 months.Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.Prior administration of thrombolytic therapy for the current admission.Manual thrombus aspiration may be used per operator discretion, but rheolytic thrombectomy is only permitted for procedural complications after randomization. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to excimer laser, rotational atherectomy, etc.).The subject requires a staged procedure of the target vessel (including branches) within 12 months or of any non-target vessel within 7 days post-procedure.Cardiogenic shock (SBP less than 80 mmHg for more than other hemodynamic support device for hypotension).Subject undergoing cardiopulmonary resuscitation (patients in whom cardiopulmonary resuscitation was successfully performed and in whom normal mental status was achieved, may be enrolled).Female patients of childbearing potential.A previous coronary interventional procedure of any kind within 30 days prior to the procedure.Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.Left bundle branch block (LBBB), paced rhythm, or other ECG abnormality interfering with assessment of ST-segment.TIMI flow of 2/3 is present prior to randomization (in case of baseline TIMI flow 0/1, blood flow must be restored).The entire lesion length requiring treatment is less than 24 mm (able to be covered by a single study stent), assessed either at baseline (if direct stenting is planned), or after pre-dilatation or thrombus aspiration (if direct stenting is not planned).The reference vessel diameter (RVD) of the infarct lesion is 2.75 to 4.0 mm by visual assessment, assessed either at baseline (if direct stenting is planned), or after pre-dilatation or thrombus aspiration (if direct stenting is not planned).Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting.The target lesion is a de novo lesion in a native coronary artery.Subject or legal representative provides written, informed consent.Subject agrees to all required follow-up procedures and visits.ST elevation more than 2 mm per lead in more than 2 contiguous leads is present in one ECG prior to consent.Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) of more than 30 minutes and less than 12 hours in duration.Why Should I Register and Submit Results?.SFDA urges all hospitals that have devices subjected to recall, to contact the company. This upgrade in the manufacturing process will improve stent retention and product performance.Īthorized Representative/Importer/Distributor: InspireMD intends to perform a manufacturing enhancement to all unexpired units of the MGuard Prime EPS systems. These complaints have not resulted in any patient injury. These complaints 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. 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. ![]() MGuard Prime Coronary Stent System Embolic Protective Stent (EPS) ![]()
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