Micro Medical Solutions: First Case Completed in STAND Study, the Pivotal Clinical Trial of MicroStent

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 .

  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 .

CONTACT: Peg Thornton, Director of Corporate and Market Development, Micro Medical Solutions 732-616-9123

About CLI

Peripheral artery disease (PAD) and critical limb ischemia (CLI) affected 215 million people worldwide in 2015, predicted to be 230 million by 2020.1 CLI currently afflicts 2.8 to 3.5 million of those with PAD and is projected to rise to 4.5 to 5.6 million.2 Rates of amputations in the general population with PAD are declining, but amputations in CLI continue to escalate. It has been estimated that 25% of CLI patients will undergo major amputation. Prognosis with respect to limb preservation in CLI patients is poor, particularly in no-option CLI patients, where six-month major amputation rates have been reported to be as high as 50%.3 If something doesn’t change, the number of amputations due to CLI could exceed one million by 2030.

References: 1. Global Peripheral Artery Disease Market: Trends & Opportunities (2015-2020), February 2016 (Page 19). Daedal Research Group. 2. Critical Limb Ischemia. Volume 1 United States Epidemiology, 2010. Accessed at[orts/cliepiusreprot.php., October 14, 2016. 3. Teraa M, Conte MS, Moll FL, Verhaar MC. Contemporary Reviews: Critical Limb Ischemia: Current Trends and Future Directions. J Am Heart Assoc 2016; 5: e002938.

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