Micro Medical Solutions (MMS) is set to begin a US pivotal clinical study to assess the safety and efficacy of MicroStent vascular stent.
The company has secured investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence the trial of MicroStent. It already secured CE mark approval for use in the EU region.
Micro Medical Solutions CEO Gregory Sullivan 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 CLI in the U.S. who face the potential for amputation.
“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.”
MicroSten has been specifically designed to achieve and maintain vessel patency, as well as enhance blood flow to decrease below-the-knee amputations in patients with critical limb ischemia (CLI) resulting from peripheral artery disease (PAD).
The company completed a three-centre and 15-patient feasibility study of MicroStent, in which the vascular stent achieved all primary endpoints for both safety and efficacy.
According to the company, the trial demonstrated in the device-related per protocol population that 90.9% of subjects had primary patency at 6 months post-index procedure, which is a composite of 90.9% subjects with freedom from occlusion and 100% were free from a clinically driven target lesion revascularisation.
Based on these outcomes, the FDA has granted IDE status to the MicroStent vascular stent.
The firm will immediately start the process to commence enrolment in the STAND clinical randomised and multicentre study (a clinical evaluation of the microstent peripheral vascular stent in subjects with arterial disease below the knee).
The study lead investigator Dr Robert Beasley said: “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.”