Research & Development
Micro Medical Solutions awarded FDA Investigational Device Exemption (IDE) approval to evaluate MicroStent for CLI and PAD
25 June 2019 -

Microvascular company Micro Medical Solutions (MMS) reported on Monday the receipt of US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to evaluate MicroStent's safety and efficacy to restore blood flow and reduce amputations from CLI and PAD diseases under a US pivotal clinical STAND trial.

In addition, MicroStent has already obtained CE Mark approval for use in the EU, disclosed the company.

According to the company, MicroStent is a vascular stent specifically 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). About 25% of CLI patients will undergo major amputation and amputations due to CLI continue to escalate.

As part of a prior three centre, 15-patient feasibility study of MicroStent, the company demonstrated in the device-related per protocol population that 90.9% of subjects had primary patency at six months post-index procedure, which is a composite of 90.9% subjects with freedom from occlusion, while 100% were free from a clinically driven target lesion revascularization. The study showed 100% of subjects had freedom from the primary safety endpoint at six months post-index procedure.

The company stated the STAND trial (Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in Subjects with Arterial Disease Below the Knee) is a randomised, multicentre pivotal clinical study of the MicroStent device in 200 patients at a maximum of 25 sites across the US.

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