Major milestone reached in journey toward FDA approval for potentially limb-saving treatment of peripheral artery disease
WILMINGTON, Mass., May 12, 2020 — Micro Medical Solutions (MMS) today announced the first implantation of the MicroStent vascular stent in the FDA randomized, multicenter 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 centers designated across the United States are now enrolling patients in STAND.
The first procedure was performed March 25 by the study's lead investigator, Dr. Robert E. Beasley of Mount Sinai Medical Center in Miami Beach, Florida. "With a very successful MicroStent procedure and positive early results from the feasibility study showing a 90.9% patency rate at one year, I'm delighted that the STAND study is now underway," Dr. Beasley said. "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 ischemia (CLI) resulting from peripheral artery disease (PAD). MMS received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) after completing a 3-center, 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 U.S. MicroStent has already obtained CE Mark approval for use outside the US.
Micro Medical Solutions CEO, Gregory Sullivan, added, "At MMS, 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 CLI from the devastation of below-the-knee amputation."
About Critical Limb Ischemia
Peripheral artery disease and critical limb ischemia (CLI) affect millions each year. It has been estimated that nearly 25% of CLI patients will undergo major amputation,1 and amputations due to CLI continue to escalate.2 For more information on CLI, visit www.micromedicalsolutions.net.
1. Henry AJ, Hevelone ND, Belkin M, Nguyen LL. Socioeconomic and hospital-related predictors of amputation for critical limb ischemia. J Vasc Surg. 2011 Feb;53(2):330-9.e1.
2. Baser O, Verpillat P, Gabriel S, et al. Prevalence, incidence, and outcomes of critical limb ischemia in the US Medicare population. Vasc Dis Mgmt. 2013:10;E26-36.
About Micro Medical Solutions
Micro Medical Solutions is on a mission to provide solutions to some of the most pressing unmet needs in microvascular intervention by helping to significantly reduce the rate of amputations, improve clinical outcomes and patient quality of life, and minimize the financial and human costs associated with the treatment of peripheral artery disease and critical limb ischemia. For more about Micro Medical Solutions, visit www.micromedicalsolutions.net.
Director of Corporate and Market Development
SOURCE Micro Medical Solutions