First case completed in STAND study, the pivotal clinical trial of MicroStent

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STANDMicro Medical Solutions has announced the first implantation of the MicroStent vascular stent in the US Food and Drug Administration (FDA) randomised, multicentre pivotal clinical study, STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in subjects with Arterial Disease Below the Knee). The 25 leading medical institutions and outpatient centres designated across the USA are now enrolling patients in STAND.

The first procedure was performed 25 March 2020 by the study’s lead investigator, Robert E Beasley of Mount Sinai Medical Center in Miami Beach, USA. “With a very successful MicroStent procedure and positive early results from the feasibility study showing a 90.9% patency rate at one year, I am delighted that the STAND study is now underway,” Beasley comments. “MicroStent offers hope for limb salvage, better health and quality of life to patients at risk for below-the-knee amputation, and the clinical trial will bring us closer to offering this new solution to thousands more candidates.”

MicroStent is a vascular stent, with both a 3Fr and 4Fr delivery system that allows for multiple access points, designed to achieve and maintain vessel patency and improve blood flow in order to reduce below-the-knee amputations for patients with critical limb-threatening ischaemia (CLTI) resulting from peripheral arterial disease (PAD). Micro Medical Solutions received Investigational Device Exemption (IDE) approval from the FDA after completing a three-centre, 15-patient feasibility study in which MicroStent met all primary endpoints for both safety and efficacy. When complete, the STAND study will include approximately 177 patients at up to 25 sites across the US. MicroStent has already obtained CE mark approval for use outside the USA.

Micro Medical Solutions CEO, Gregory Sullivan, adds, “Our leadership team and scientific advisory board have worked diligently to design and plan the STAND trial, with encouraging response from the FDA every step of the way. This first case is a source of great pride and inspiration as we continue to work toward FDA approval, which will help save many patients with CLTI from the devastation of below-the-knee amputation.”


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