Micro Medical Systems Gets FDA Breakthrough Status for Vascular Stent

Micro Medical Systems has been given Breakthrough Device designation by the FDA for its MicroStent vascular stent.

The device is designed to reduce amputations and fatalities in patients with critical limb-threatening ischemia resulting from peripheral artery disease.

The company is currently conducting a multicenter pivotal trial for the device. The U.S. study, which began in May 2020, will continue at up to 25 sites, while an additional study is enrolling patients at centers in the EU.