Pexels
The Food and Drug Administration gave Micro Medical approval for an Investigational Device Exemption (IDE) to start a clinical trial to investigate the safety of the MicroStent.
The MicroStent is used 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), according to Cision.
The FDA granted IDE status after a 3-center, 15-patient feasibility study. Some 90.9 percent of patients had primary patency six months post-index procedure and 100 percent did not have a clinically driven target lesion revascularization. Additionally, no patients had major adverse limb events or died during the study.
“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 re-intervention to effectively treat and lessen the impending limb and tissue loss,” said the study's lead investigator, Robert Beasley of Mount Sinai Medical Center in Miami Beach.
The STAND (Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in Subjects with Arterial Disease Below the Knee) Study will be the next step toward FDA approval. It will be a randomized, multicenter clinical study of 200 patients at 25 sites.
