MicroStent to treat PAD below the knee receives FDA breakthrough device designation

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Micro Medical Solutions (MMS) recently revealed Food and Drug Administration (FDA) breakthrough device designation for its MicroStent vascular stent. This novel technology is designed to achieve and maintain vessel patency, enhance wound treatment and improve quality of life and blood flow in order to reduce amputation and mortality for patients with chronic limb-threatening ischemia (CLTI) resulting from peripheral arterial disease (PAD).

“As we remain focused on the completion of our FDA clinical study, STAND, it is gratifying to know we are now one step closer to our goal to help as many CLTI patients as possible live without the trauma of amputation,” said Micro Medical Solutions CEO Gregory Sullivan.

MMS is currently engaged in an FDA randomized, multicenter pivotal clinical study for MicroStent, called STAND (A clinical evaluation of the MicroStent peripheral vascular stent in subjects with arterial disease below the knee), which began in May 2020 and will continue at up to 25 sites across the US.

In addition, the MMS study HEAL (An all-comers observational study of the MicroStent peripheral vascular stent system in subjects with peripheral arterial disease) is currently enrolling patients at centers in the European Union.

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