Micro Medical Solutions Receives Approval for Pivotal Clinical Trial of MicroStent
June 24, 2019—Micro Medical Solutions (MMS) announced that it has received investigational device exemption (IDE) approval from the FDA to initiate a United States pivotal clinical trial evaluating the safety and efficacy of its MicroStent peripheral vascular stent.
MMS will immediately initiate the process to begin enrollment in the STAND trial, which is a randomized, multicenter pivotal clinical study of the MicroStent device in patients with below-the-knee artery disease. The trial will include approximately 200 patients at a maximum of 25 sites across the United States and support the company's efforts to gain FDA approval of the device.
According to MMS, MicroStent is designed to achieve and maintain vessel patency and improve blood flow to reduce below-the-knee amputations for patients with critical limb ischemia (CLI) resulting from peripheral artery disease (PAD). The device has obtained CE Mark approval for use in the European Union.
The company advised that the FDA granted IDE status based on the outcomes of a three-center, 15-patient feasibility study completed in the fall of 2018, in which MicroStent met all primary endpoints for both safety and efficacy.
The study demonstrated a 90.9% primary patency rate at 6 months post-index procedure in the device-related per-protocol population, which is a composite of 90.9% of patients who were free from occlusion, and 100% of patients who were free from a clinically driven target lesion revascularization. The study also showed 100% of patients had freedom from the primary safety endpoint at 6 months post-index procedure, which is a composite of 100% of patients with freedom from death and 100% freedom from major adverse limb events in the same population.
The study's lead investigator, Robert E. Beasley, MD, commented in the MMS announcement, “Because CLI represents the most severe clinical manifestation of PAD, we are excited to have a device that offers physicians multiple access points, as well as a trial that allows for reintervention to effectively treat and lessen the impending limb and tissue loss.” Dr. Beasley is Section Chief of Vascular and Interventional Radiology at Mount Sinai Center in Miami Beach, Florida.
Jihad A. Mustapha, MD, added, “For patients with PAD, the risk of amputation is high, particularly if they have CLI. Amputees face decreased quality of life, as well as amputation-associated mortality. I look forward to the clinical trial for MicroStent because we need new solutions to help save CLI patients from amputation.” Dr. Mustapha is an interventional cardiologist and Cofounder of Advanced Cardiac & Vascular Centers for Amputation Prevention in Grand Rapids, Michigan.