Micro Medical Solutions Receives FDA IDE Approval for Pivotal Clinical Trial of MicroStent
Cioffe Enterprises [CEI], is pleased to announce it has acquired a position in Micro Medical Solutions (MMS), an innovator in the field of microvascular interventions that improve clinical outcomes and quality of life.
WILMINGTON, Mass., June 24, 2019 /PRNewswire – MMS announced today that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). IDE approval allows MMS to initiate a U.S. pivotal clinical trial to evaluate MicroStent’s safety and efficacy. MicroStent has already obtained CE Mark approval for use in the EU.
MicroStent is a vascular stent specifically designed to achieve and maintain vessel patency and improve blood flow in order to reduce below-the-knee amputations for patients with critical limb ischemia (CLI) resulting from peripheral artery disease (PAD). Last fall, MMS completed a 3-center, 15-patient feasibility study of MicroStent in which MicroStent met all primary endpoints for both safety and efficacy.
The study demonstrated in the device-related per protocol population that 90.9% of subjects had primary patency at 6 months post-index procedure, which is a composite of 90.9% subjects with freedom from occlusion, while 100% were free from a clinically driven target lesion revascularization. The study also showed 100% of subjects had freedom from the primary safety endpoint at 6 months post-index procedure, which is a composite of 100.0% subjects with freedom from death and 100% freedom from MALE (major adverse limb events) in the same population.
The FDA has granted IDE status based on these outcomes. MMS will immediately initiate the process to begin enrollment in the clinical trial, called the STAND study (A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in subjects with Arterial Disease Below the Knee).
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