May 12, 2020
Micro Medical Solutions Begins Pivotal STAND Trial of MicroStent to Treat BTK Arterial Disease
May 12, 2020—Micro Medical Solutions (MMS) announced the first implantation of the company’s MicroStent vascular stent in STAND, the randomized, multicenter pivotal clinical study to support FDA approval of the device to treat arterial disease below the knee.
MMS received FDA investigational device exemption approval for the pivotal trial after completing a three-center, 15-patient feasibility study in which MicroStent met all primary endpoints for both safety and efficacy.
Medical institutions and outpatient centers in the United States are now enrolling patients in the STAND trial. When completed, the study will include approximately 177 patients enrolled at up to 25 sites across the United States.
The first procedure was performed on March 25 by the study’s lead investigator, Robert E. Beasley, MD, 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 1 year, I’m delighted that the STAND study is now underway,” commented Dr. Beasley in the company’s announcement. “MicroStent offers hope for limb salvage, better health, and quality of life to patients at risk for below-the-knee [BTK] amputation, and the clinical trial will bring us closer to offering this new solution to thousands more candidates.”
According to the company, the MicroStent vascular stent features both a 3-F and 4-F delivery system to allow for multiple access points. It is designed to achieve and maintain vessel patency and improve blood flow in order to reduce BTK amputations for patients with critical limb ischemia resulting from peripheral artery disease. The MicroStent was granted European CE Mark approval in 2017.