Micro Medical Solutions today said it has received FDA breakthrough device designation for its MicroStent vascular stent.
The stent is designed to maintain vessel patency, enhance wound treatment and improve quality of life and blood flow to reduce amputations and mortality for patients with critical limb-threatening ischemia (CLTI) from peripheral artery disease.
“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 recognizing the importance and severity of CLTI and look forward to collaborating with them as we go through the PMA process,” CEO Gregory Sullivan said in a news release. “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.”
The MicroStent is currently in an FDA randomized, multi-center pivotal clinical study that began in May 2020 and will continue up to 25 sites across the U.S. to study the peripheral vascular stent in people with arterial disease below the knee. Micro Medical Solutions is also currently enrolling patients in the EU for an all-comers observational study of the MicroStent in people with peripheral arterial disease.