Micro Medical Solutions (MMS) recently announced that the US Food and Drug Administration (FDA) has granted 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 ischaemia (CLTI) resulting from peripheral arterial disease (PAD).
“FDA breakthrough device designation is an exciting step forward for MMS and for patients with CLTI, who will have expedited access to MicroStent. We are pleased that the FDA is recognising the importance and severity of CLTI and look forward to collaborating with them as we go through the PMA [premarket approval] process,” said Micro Medical Solutions CEO Gregory Sullivan. “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.”
MMS is currently engaged in an FDA randomised, multicentre 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 USA. 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 centres in the EU.