Micro Medical Solutions’ MicroStent Vascular Stent Receives FDA Breakthrough Device Designation

May 4, 2021—Micro Medical Solutions (MMS) announced that the FDA has granted Breakthrough Device designation for the company’s MicroStent vascular stent to treat patients with chronic limb-threatening ischemia resulting from peripheral artery disease.

According to MMS, the MicroStent technology is designed to reduce amputation and mortality by achieving and maintaining vessel patency, enhancing wound treatment, and improving quality of life and blood flow.

MMS stated that it is engaged in the randomized, multicenter STAND pivotal clinical study for MicroStent in patients with below-the-knee arterial disease. The study began in May 2020 and will continue at up to 25 sites across the United States. In addition, the company’s all-comers observational HEAL study of the MicroStent is currently enrolling patients at centers in the European Union.

The company advised that FDA Breakthrough Device designation is reserved for technologies that demonstrate improved effectiveness compared to the standard of care in the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program seeks to give patients and doctors timely access to these medical devices by speeding up their development, assessment, and review while preserving the statutory standards for premarket approval. To further enhance patients’ access to essential new medical technologies, the Medicare Coverage of Innovative Technology ensures FDA Breakthrough Devices are covered for 4 years.