Micro Medical Solutions said yesterday that it won a nod from the FDA to run a clinical trial of its MicroStent below-the-knee device for treating peripheral artery disease.
The Wilmington, Mass.-based company’s MicroStent won CE Mark approval in the European Union in February 2017. A small feasibility study completed last fall met all primary endpoints and prompted the FDA to grant an investigational device exemption for a pivotal U.S. trial, MMS said. Enrollment in the 200-patient, randomized Stand trial is slated to begin immediately, the company said.
“IDE approval for the pivotal clinical study of MicroStent is an encouraging step forward in our efforts to bring this technology to patients with [critical limb ischemia] in the U.S. who face the potential for amputation,” CEO Gregory Sullivan said in prepared remarks. “MMS developed the MicroStent platform in response to these patients’ needs, and we are excited to move closer to putting MicroStent in the hands of U.S. interventionalists treating CLI.”
“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,” added lead investigator Dr. Robert Beasley of Miami Beach’s Mount Sinai Medical Center.